ClinicalTrials.gov
ClinicalTrials.gov Menu

To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01068860
Recruitment Status : Completed
First Posted : February 15, 2010
Results First Posted : September 5, 2011
Last Update Posted : September 5, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Type 2 Diabetes Mellitus
Impaired Glucose Tolerance
Interventions Drug: Canakinumab 150 mg
Drug: Placebo to Canakinumab
Enrollment 246

Recruitment Details  
Pre-assignment Details Qualified patients entered a 4-week run-in period while taking current therapy thru the study. After the run-in, patients had the baseline meal challenge. Then patients were randomized. A 2nd meal challenge was performed after 4 wks. This ended the study except for a follow up phone call after approx.90 days to record serious adverse events (SAEs)
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Period Title: Overall Study
Started 33 17 33 17 32 16 28 15 28 27
Completed 33 16 33 16 32 14 28 15 28 23
Not Completed 0 1 0 1 0 2 0 0 0 4
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             2             0             0             0             3
Administrative problems; misrandomized             0             0             0             1             0             0             0             0             0             1
Lost to Follow-up             0             1             0             0             0             0             0             0             0             0
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT Total
Hide Arm/Group Description Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. Total of all reporting groups
Overall Number of Baseline Participants 33 17 33 17 32 16 28 15 28 27 246
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 17 participants 33 participants 17 participants 32 participants 16 participants 28 participants 15 participants 28 participants 27 participants 246 participants
55.9  (10.50) 56.5  (9.30) 60.0  (8.17) 59.4  (8.02) 59.1  (10.63) 57.2  (9.39) 58.6  (10.11) 57.0  (13.86) 52.8  (10.90) 57.6  (10.07) 57.4  (10.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 17 participants 33 participants 17 participants 32 participants 16 participants 28 participants 15 participants 28 participants 27 participants 246 participants
Female
19
  57.6%
3
  17.6%
14
  42.4%
10
  58.8%
11
  34.4%
5
  31.3%
13
  46.4%
10
  66.7%
12
  42.9%
16
  59.3%
113
  45.9%
Male
14
  42.4%
14
  82.4%
19
  57.6%
7
  41.2%
21
  65.6%
11
  68.8%
15
  53.6%
5
  33.3%
16
  57.1%
11
  40.7%
133
  54.1%
1.Primary Outcome
Title Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks.
Hide Description Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal.A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include patients from the IGT population
Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 32 16 31 15 31 14 26 15 28 21
Least Squares Mean (Standard Error)
Unit of Measure: pmol/min/m^2/mmol/L
-0.06  (0.943) -0.23  (1.334) 0.04  (0.958) 0.45  (1.378) -0.79  (0.958) 1.16  (1.426) 1.23  (1.046) -0.49  (1.378) -1.50  (1.975) -1.93  (1.737)
2.Secondary Outcome
Title Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks
Hide Description Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population
Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 32 16 30 15 31 14 26 15 28 20
Least Squares Mean (Standard Error)
Unit of Measure: pmol/min/m^2/mmol/L
0.21  (2.000) -2.15  (2.829) -2.98  (2.066) 2.02  (2.921) 0.15  (2.032) 1.19  (3.024) -0.43  (2.219) -0.51  (2.921) -0.71  (1.040) -1.00  (1.518)
3.Secondary Outcome
Title Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks.
Hide Description Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose, insulin and C-peptide at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 33 16 31 15 32 14 26 15 28 21
Least Squares Mean (Standard Error)
Unit of Measure: pmol/min/m^2/mmol/L
0.44  (0.858) -0.99  (1.232) -0.32  (0.885) 1.22  (1.272) -0.63  (0.871) 1.24  (1.317) 0.53  (0.966) -0.49  (1.272) -1.38  (1.356) -1.35  (1.330)
4.Secondary Outcome
Title Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks
Hide Description

Change in Fasting Glucose Level measured from plasma taken at Baseline and after 4 weeks of treatment.

A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population

Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 33 16 31 16 32 14 26 15 28 21
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.32  (0.272) 0.33  (0.391) -0.20  (0.281) -0.23  (0.391) -0.33  (0.276) -0.36  (0.418) -0.26  (0.307) -0.80  (0.404) -0.06  (0.107) 0.10  (0.094)
5.Secondary Outcome
Title Mean Change in Fructosamine, From Baseline to 4 Weeks
Hide Description

Change in Fructosamine Level taken from plasma, measured at Baseline and after 4 weeks of treatment.

A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population

Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 33 16 31 16 32 14 27 15 28 23
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-5.30  (3.727) -0.75  (5.353) -3.45  (3.846) -7.50  (5.353) -1.81  (3.785) -3.07  (5.722) -3.00  (4.121) -19.73  (5.528) -6.36  (3.259) 1.39  (3813)
6.Secondary Outcome
Title Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks
Hide Description

Change in Fasting Insulin level taken from plasma, measured at Baseline and after 4 weeks of treatment.

A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population

Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 33 15 30 15 31 13 26 15 28 23
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
-3.58  (8.703) 10.73  (12.908) -16.07  (9.128) -9.40  (12.908) -0.77  (8.979) 2.31  (13.866) 21.27  (9.805) 25.67  (12.908) -.021  (6.093) -3.43  (4.554)
7.Secondary Outcome
Title Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks
Hide Description

The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. The score is calculated by the equation: 1 /(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). In normal subjects the mean score ± SE is 0.366 ± 0.029.

A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.

Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 33 15 30 15 31 13 25 15 28 21
Least Squares Mean (Standard Error)
Unit of Measure: number
0.004  (0.0080) -0.000  (0.0119) 0.002  (0.0084) 0.009  (0.0119) 0.018  (0.0083) -0.001  (0.0128) -0.003  (0.0092) 0.005  (0.0119) -0.001  (0.0051) 0.001  (0.0034)
8.Secondary Outcome
Title Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks
Hide Description GDI 1 is the product of insulin sensitivity index (Si)during the 1st phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR).GDI 2 is the product of (Si)during the 2nd phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR). A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT group.
Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 32 15 30 15 30 13 25 15 26 21
Least Squares Mean (Standard Error)
Unit of Measure: number
Index 1 0.06  (0.374) -0.29  (0.546) 0.06  (0.386) 0.37  (0.546) 0.24  (0.386) 0.33  (0.586) 0.25  (0.423) -0.27  (0.546) -0.51  (0.672) -0.64  (0.530)
Index 2 (n= 32,15, 29,15, 30,13, 25, 15, 20, 26) 0.14  (0.652) -0.81  (0.952) -0.94  (0.685) 0.81  (0.952) 0.62  (0.673) 0.49  (1.023) -0.21  (0.738) -0.25  (0.952) -0.16  (0.396) -0.31  (0.509)
9.Secondary Outcome
Title Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks
Hide Description

Change in glucose level measured after 2 hours of fasting. Blood sample was drawn at 0 minutes and at 240 minutes.

A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.

Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 32 16 31 15 31 14 26 15 28 21
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.53  (0.389) 0.13  (0.551) -0.60  (0.396) 0.18  (0.551) -1.08  (0.396) -0.56  (0.589) -0.56  (0.432) -0.16  (0.569) -0.26  (0.241) -0.25  (0.213)
10.Secondary Outcome
Title Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks
Hide Description Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.
Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 32 16 31 15 31 14 26 15 28 21
Least Squares Mean (Standard Error)
Unit of Measure: pmol*hour/L
-9.37  (40.538) 1.21  (60.128) -73.25  (42.517) -38.32  (60.128) -36.96  (41.825) 8.46  (64.587) 163.87  (45.670) 139.24  (60.128) 44.27  (60.700) -106.68  (53.615)
11.Secondary Outcome
Title Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks
Hide Description Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.
Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 32 16 31 15 31 14 26 15 28 21
Least Squares Mean (Standard Error)
Unit of Measure: nmol*hour/L
-0.18  (0.225) -0.18  (0.324) -0.21  (0.232) 0.12  (0.334) -0.61  (0.229) 0.02  (0.346) 0.16  (0.249) -0.29  (0.334) -0.43  (0.253) -0.40  (0.288)
12.Secondary Outcome
Title Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks
Hide Description Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.
Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 32 16 31 15 31 14 26 15 28 21
Least Squares Mean (Standard Error)
Unit of Measure: mmol*hr/L
-0.59  (1.296) 0.46  (1.861) -1.37  (1.337) -1.24  (1.861) -3.58  (1.316) -2.88  (1.990) -1.49  (1.460) -1.76  (1.922) -0.71  (0.554) -0.10  (0.512)
13.Secondary Outcome
Title Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks
Hide Description

Change in peak plasma glucose level as measured from Baseline to 4 weeks of treatment.

A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.

Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 32 16 31 15 31 14 26 15 28 21
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.41  (0.369) 0.21  (0.531) -0.43  (0.381) -0.03  (0.531) -0.82  (0.375) -0.77  (0.567) -0.15  (0.416) -0.60  (0.548) -0.34  (0.181) -0.04  (0.189)
14.Secondary Outcome
Title Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks
Hide Description Change in mean peak plasma Insulin level as measured from Baseline to 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 32 16 31 15 31 14 26 15 28 21
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
8.09  (22.673) 44.56  (32.561) -55.07  (23.779) 11.33  (33.629) 5.13  (23.392) -5.15  (36.123) 91.74  (25.065) 36.87  (33.629) 56.21  (27.952) -26.43  (40.163)
15.Secondary Outcome
Title Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks
Hide Description

Change in mean peak plasma C-peptide level measured from Baseline to 4 weeks of treatment.

A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.

Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 32 16 31 15 31 14 26 15 28 21
Least Squares Mean (Standard Error)
Unit of Measure: nmol/L
-0.04  (0.081) -0.04  (0.116) -0.10  (0.083) 0.16  (0.120) -0.21  (0.082) 0.05  (0.124) 0.07  (0.089) -0.14  (0.120) -0.18  (0.101) -0.18  (0.134)
16.Secondary Outcome
Title Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks
Hide Description An adverse event is any unwanted event, whether related to study drug or not occuring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit.
Time Frame Baseline, 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population consisted of all participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metformin + Sulfonylurea Placebo + Metformin + Sulfonylurea Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia Placebo + Met + Sulfonyl + Thiaz Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Participants With IGT Placebo in Participants With IGT
Hide Arm/Group Description:
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Overall Number of Participants Analyzed 33 17 32 17 32 16 28 15 28 26
Measure Type: Number
Unit of Measure: participants
Number of Participants with Serious Adverse Events 0 0 0 0 0 0 0 0 0 0
Number of Participants with Non-serious AEs > 5% 0 4 6 3 4 3 6 3 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description Safety Set included all randomized participants who received study drug.
 
Arm/Group Title Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metforimin + Sulfonylurea Placebo + Metforimin + Sulfonylurea Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione Placebo + Met + Sulfonyl + Thiazolidinedione Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Patients With IGT Placebo in Patients With IGT
Hide Arm/Group Description Eligible participants received a single subcutaneous injection Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
All-Cause Mortality
Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metforimin + Sulfonylurea Placebo + Metforimin + Sulfonylurea Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione Placebo + Met + Sulfonyl + Thiazolidinedione Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Patients With IGT Placebo in Patients With IGT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metforimin + Sulfonylurea Placebo + Metforimin + Sulfonylurea Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione Placebo + Met + Sulfonyl + Thiazolidinedione Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Patients With IGT Placebo in Patients With IGT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/17 (0.00%)   0/32 (0.00%)   0/17 (0.00%)   0/32 (0.00%)   0/16 (0.00%)   0/28 (0.00%)   0/15 (0.00%)   0/28 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Canakinumab 150 mg + Metformin Placebo + Metformin Canakinumab 150 mg + Metforimin + Sulfonylurea Placebo + Metforimin + Sulfonylurea Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione Placebo + Met + Sulfonyl + Thiazolidinedione Canakinumab 150 mg + Insulin Placebo + Insulin Canakinumab 150 mg in Patients With IGT Placebo in Patients With IGT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   4/17 (23.53%)   6/32 (18.75%)   3/17 (17.65%)   4/32 (12.50%)   3/16 (18.75%)   6/28 (21.43%)   3/15 (20.00%)   0/28 (0.00%)   0/26 (0.00%) 
Ear and labyrinth disorders                     
Vertigo  1  0/33 (0.00%)  1/17 (5.88%)  0/32 (0.00%)  0/17 (0.00%)  0/32 (0.00%)  0/16 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  0/28 (0.00%)  0/26 (0.00%) 
Eye disorders                     
Vision blurred  1  0/33 (0.00%)  0/17 (0.00%)  0/32 (0.00%)  0/17 (0.00%)  1/32 (3.13%)  1/16 (6.25%)  0/28 (0.00%)  0/15 (0.00%)  0/28 (0.00%)  0/26 (0.00%) 
Visual impairment  1  0/33 (0.00%)  0/17 (0.00%)  0/32 (0.00%)  0/17 (0.00%)  0/32 (0.00%)  1/16 (6.25%)  0/28 (0.00%)  0/15 (0.00%)  0/28 (0.00%)  0/26 (0.00%) 
Gastrointestinal disorders                     
Diarrhoea  1  0/33 (0.00%)  1/17 (5.88%)  1/32 (3.13%)  0/17 (0.00%)  0/32 (0.00%)  0/16 (0.00%)  0/28 (0.00%)  1/15 (6.67%)  0/28 (0.00%)  0/26 (0.00%) 
Dyspepsia  1  0/33 (0.00%)  0/17 (0.00%)  0/32 (0.00%)  0/17 (0.00%)  0/32 (0.00%)  0/16 (0.00%)  0/28 (0.00%)  1/15 (6.67%)  0/28 (0.00%)  0/26 (0.00%) 
Nausea  1  0/33 (0.00%)  0/17 (0.00%)  1/32 (3.13%)  0/17 (0.00%)  0/32 (0.00%)  1/16 (6.25%)  1/28 (3.57%)  0/15 (0.00%)  0/28 (0.00%)  0/26 (0.00%) 
Infections and infestations                     
Bronchitis  1  0/33 (0.00%)  0/17 (0.00%)  1/32 (3.13%)  0/17 (0.00%)  0/32 (0.00%)  0/16 (0.00%)  0/28 (0.00%)  1/15 (6.67%)  0/28 (0.00%)  0/26 (0.00%) 
Hordeolum  1  0/33 (0.00%)  1/17 (5.88%)  0/32 (0.00%)  0/17 (0.00%)  0/32 (0.00%)  0/16 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  0/28 (0.00%)  0/26 (0.00%) 
Nasopharyngitis  1  0/33 (0.00%)  2/17 (11.76%)  0/32 (0.00%)  1/17 (5.88%)  0/32 (0.00%)  0/16 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  0/28 (0.00%)  0/26 (0.00%) 
Pharyngitis  1  0/33 (0.00%)  0/17 (0.00%)  1/32 (3.13%)  1/17 (5.88%)  0/32 (0.00%)  0/16 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  0/28 (0.00%)  0/26 (0.00%) 
Investigations                     
Antinuclear antibody positive  1  0/33 (0.00%)  1/17 (5.88%)  0/32 (0.00%)  0/17 (0.00%)  0/32 (0.00%)  0/16 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  0/28 (0.00%)  0/26 (0.00%) 
Metabolism and nutrition disorders                     
Hypoglycaemia  1  0/33 (0.00%)  0/17 (0.00%)  0/32 (0.00%)  1/17 (5.88%)  0/32 (0.00%)  0/16 (0.00%)  3/28 (10.71%)  0/15 (0.00%)  0/28 (0.00%)  0/26 (0.00%) 
Nervous system disorders                     
Dizziness  1  0/33 (0.00%)  0/17 (0.00%)  1/32 (3.13%)  0/17 (0.00%)  2/32 (6.25%)  1/16 (6.25%)  0/28 (0.00%)  0/15 (0.00%)  0/28 (0.00%)  0/26 (0.00%) 
Tremor  1  0/33 (0.00%)  0/17 (0.00%)  1/32 (3.13%)  1/17 (5.88%)  2/32 (6.25%)  0/16 (0.00%)  2/28 (7.14%)  0/15 (0.00%)  0/28 (0.00%)  0/26 (0.00%) 
Psychiatric disorders                     
Confusional state  1  0/33 (0.00%)  0/17 (0.00%)  0/32 (0.00%)  1/17 (5.88%)  0/32 (0.00%)  0/16 (0.00%)  0/28 (0.00%)  0/15 (0.00%)  0/28 (0.00%)  0/26 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Dysphonia  1  0/33 (0.00%)  0/17 (0.00%)  0/32 (0.00%)  0/17 (0.00%)  0/32 (0.00%)  0/16 (0.00%)  1/28 (3.57%)  1/15 (6.67%)  0/28 (0.00%)  0/26 (0.00%) 
Skin and subcutaneous tissue disorders                     
Hyperhidrosis  1  0/33 (0.00%)  0/17 (0.00%)  1/32 (3.13%)  0/17 (0.00%)  2/32 (6.25%)  1/16 (6.25%)  1/28 (3.57%)  0/15 (0.00%)  0/28 (0.00%)  0/26 (0.00%) 
Rash papular  1  0/33 (0.00%)  0/17 (0.00%)  0/32 (0.00%)  0/17 (0.00%)  0/32 (0.00%)  0/16 (0.00%)  0/28 (0.00%)  1/15 (6.67%)  0/28 (0.00%)  0/26 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Dr. Tom Thuren/Global Brand Medical Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-1828
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01068860     History of Changes
Other Study ID Numbers: CACZ885I2207
First Submitted: February 12, 2010
First Posted: February 15, 2010
Results First Submitted: August 3, 2011
Results First Posted: September 5, 2011
Last Update Posted: September 5, 2011