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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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01068860
First received: February 12, 2010
Last updated: August 3, 2011
Last verified: August 2011
Results First Received: August 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Type 2 Diabetes Mellitus
Impaired Glucose Tolerance
Interventions: Drug: Canakinumab 150 mg
Drug: Placebo to Canakinumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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)

Reporting Groups
  Description
Canakinumab 150 mg + Metformin 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
Placebo + Metformin 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
Canakinumab 150 mg + Metformin + Sulfonylurea 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.
Placebo + Metformin + Sulfonylurea 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.
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia 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.
Placebo + Met + Sulfonyl + Thiaz 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.
Canakinumab 150 mg + Insulin 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
Placebo + Insulin 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
Canakinumab 150 mg in Participants With IGT 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.
Placebo in Participants With IGT 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.

Participant Flow:   Overall Study
    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
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 
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 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Canakinumab 150 mg + Metformin 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
Placebo + Metformin 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
Canakinumab 150 mg + Metformin + Sulfonylurea 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.
Placebo + Metformin + Sulfonylurea 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.
Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia 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.
Placebo + Met + Sulfonyl + Thiaz 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.
Canakinumab 150 mg + Insulin 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
Placebo + Insulin 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
Canakinumab 150 mg in Participants With IGT 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.
Placebo in Participants With IGT 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 Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 33   17   33   17   32   16   28   15   28   27   246 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
 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) 
Gender 
[Units: Participants]
                     
Female   19   3   14   10   11   5   13   10   12   16   113 
Male   14   14   19   7   21   11   15   5   16   11   133 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks.   [ Time Frame: Baseline, 4 weeks ]

2.  Secondary:   Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks   [ Time Frame: Baseline, 4 weeks ]

3.  Secondary:   Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks.   [ Time Frame: Baseline, 4 weeks ]

4.  Secondary:   Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks   [ Time Frame: Baseline, 4 weeks ]

5.  Secondary:   Mean Change in Fructosamine, From Baseline to 4 Weeks   [ Time Frame: Baseline, 4 weeks ]

6.  Secondary:   Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks   [ Time Frame: Baseline, 4 weeks ]

7.  Secondary:   Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks   [ Time Frame: Baseline, 4 weeks ]

8.  Secondary:   Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks   [ Time Frame: Baseline, 4 weeks ]

9.  Secondary:   Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks   [ Time Frame: Baseline, 4 weeks ]

10.  Secondary:   Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks   [ Time Frame: Baseline, 4 weeks ]

11.  Secondary:   Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks   [ Time Frame: Baseline, 4 weeks ]

12.  Secondary:   Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks   [ Time Frame: Baseline, 4 weeks ]

13.  Secondary:   Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks   [ Time Frame: Baseline, 4 weeks ]

14.  Secondary:   Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks   [ Time Frame: Baseline, 4 weeks ]

15.  Secondary:   Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks   [ Time Frame: Baseline, 4 weeks ]

16.  Secondary:   Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks   [ Time Frame: Baseline, 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Tom Thuren/Global Brand Medical Director
Organization: Novartis Pharmaceuticals
phone: 862-778-1828
e-mail: tom.thuren@novartis.com



Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01068860     History of Changes
Other Study ID Numbers: CACZ885I2207
Study First Received: February 12, 2010
Results First Received: August 3, 2011
Last Updated: August 3, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India
Italy: The Italian Medicines Agency
United States: Food and Drug Administration