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Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01915849
Recruitment Status : Completed
First Posted : August 5, 2013
Results First Posted : February 6, 2015
Last Update Posted : February 6, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator)
Condition Type 2 Diabetes Mellitus
Interventions Drug: LIK066
Drug: Placebo
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg
Hide Arm/Group Description Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days. Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods. Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods. Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods. Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
Period Title: Treatment Period 1 (4 Days)
Started 5 3 3 3
Completed 3 3 3 3
Not Completed 2 0 0 0
Reason Not Completed
Protocol Violation             1             0             0             0
Withdrawal by Subject             1             0             0             0
Period Title: Treatment Period 2 (4 Days)
Started 3 3 3 3
Completed 3 3 3 3
Not Completed 0 0 0 0
Period Title: Treatment Period 3 (4 Days)
Started 3 3 3 3
Completed 3 3 3 3
Not Completed 0 0 0 0
Period Title: Treatment Period 4 (4 Days)
Started 3 3 3 3
Completed 3 3 3 3
Not Completed 0 0 0 0
Arm/Group Title Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg Total
Hide Arm/Group Description Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days. Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods. Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods. Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods. Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods. Total of all reporting groups
Overall Number of Baseline Participants 5 3 3 3 14
Hide Baseline Analysis Population Description
Safety analysis set: all patients that received study drug and with no protocol deviations with relevant impact on safety.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 3 participants 3 participants 3 participants 14 participants
53.4  (9.29) 54.0  (10.54) 62.3  (3.06) 56.0  (8.19) 56.0  (8.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 3 participants 3 participants 14 participants
Female
3
  60.0%
1
  33.3%
2
  66.7%
1
  33.3%
7
  50.0%
Male
2
  40.0%
2
  66.7%
1
  33.3%
2
  66.7%
7
  50.0%
1.Primary Outcome
Title Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose
Hide Description Glucose fluxes during a mixed meal were measured using a dual glucose tracer method and non-steady state Steele equations. The rate of appearance of meal (or exogenous) glucose in the blood (also referred to as intestinal glucose absorption or Ra meal) after a mixed meal following LIK066 administration on Days 1 and 4 was the primary PD assessment in this study.The postprandial AUC was calculated using the linear trapezoidal rule. The sample collected at 7 hours after the start of the infusion was treated as the pre-meal, 0 hour measurement for the AUC0-5 hr calculation.
Time Frame Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4)
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacodynamic (PD) analysis set included all patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.
Arm/Group Title LIK066 15 mg LIK066 50 mg LIK066 150 mg Placebo
Hide Arm/Group Description:
All patients who have received LIK066 15 mg once daily for 4 days.
All patients who have received LIK066 50 mg once daily for 4 days.
All patients who have received LIK066 150 mg once daily for 4 days.
All patients who have received placebo once daily for 4 days.
Overall Number of Participants Analyzed 14 12 12 11
Mean (Standard Deviation)
Unit of Measure: (umol/kg FFM/min)*hr
Day 1 101.97  (29.348) 93.89  (25.852) 63.84  (22.589) 97.76  (30.615)
Day 4 109.99  (27.144) 117.81  (30.881) 112.45  (31.129) 103.97  (23.335)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety analysis set: all patients that received study drug and with no protocol deviations with relevant impact on safety.
 
Arm/Group Title Placebo LIK066 15 mg LIK066 50 mg LIK066 150 mg
Hide Arm/Group Description Placebo LIK066 15 mg LIK066 50 mg LIK066 150 mg
All-Cause Mortality
Placebo LIK066 15 mg LIK066 50 mg LIK066 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo LIK066 15 mg LIK066 50 mg LIK066 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/14 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo LIK066 15 mg LIK066 50 mg LIK066 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/12 (41.67%)   8/14 (57.14%)   7/12 (58.33%)   11/12 (91.67%) 
Blood and lymphatic system disorders         
Anaemia  1  1/12 (8.33%)  0/14 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Eye disorders         
Vision blurred  1  1/12 (8.33%)  0/14 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  0/12 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Diarrhoea  1  0/12 (0.00%)  0/14 (0.00%)  2/12 (16.67%)  8/12 (66.67%) 
Flatulence  1  0/12 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  1/12 (8.33%) 
Nausea  1  1/12 (8.33%)  2/14 (14.29%)  2/12 (16.67%)  4/12 (33.33%) 
Vomiting  1  1/12 (8.33%)  0/14 (0.00%)  1/12 (8.33%)  1/12 (8.33%) 
General disorders         
Cyst  1  0/12 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Fatigue  1  0/12 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Implant site haemorrhage  1  1/12 (8.33%)  0/14 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Non-cardiac chest pain  1  0/12 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Infections and infestations         
Rash pustular  1  0/12 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/12 (0.00%) 
Upper respiratory tract infection  1  0/12 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Vulvovaginitis  1  0/12 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Injury, poisoning and procedural complications         
Incision site erythema  1  0/12 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Metabolism and nutrition disorders         
Hypoglycaemia  1  2/12 (16.67%)  3/14 (21.43%)  2/12 (16.67%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/12 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/12 (0.00%) 
Nervous system disorders         
Headache  1  0/12 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/12 (0.00%) 
Tremor  1  0/12 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/12 (0.00%) 
Reproductive system and breast disorders         
Vulvovaginal pruritus  1  0/12 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/12 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis contact  1  0/12 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/12 (0.00%) 
Ecchymosis  1  0/12 (0.00%)  2/14 (14.29%)  0/12 (0.00%)  2/12 (16.67%) 
Erythema  1  1/12 (8.33%)  0/14 (0.00%)  2/12 (16.67%)  1/12 (8.33%) 
Pruritus  1  1/12 (8.33%)  0/14 (0.00%)  1/12 (8.33%)  0/12 (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 or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: trialandresults.registries@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01915849    
Other Study ID Numbers: CLIK066A2201
First Submitted: August 1, 2013
First Posted: August 5, 2013
Results First Submitted: January 22, 2015
Results First Posted: February 6, 2015
Last Update Posted: February 6, 2015