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To Investigate the Safety, Tolerability and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01725126
First Posted: November 12, 2012
Last Update Posted: October 23, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: August 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Obesity
Interventions: Drug: GSK2890457
Drug: Metformin
Drug: Placebo
Drug: Liraglutide

  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
The study was conducted in 3 parts in healthy male and female participants aged 18 to 70 years in Part A and in participants with type 2 diabetes (T2D) in Part B and C across three centers of United States of America.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 15 participants were randomized in Part A, 20 were randomized in Part B and 18 were randomized in Part C.

Reporting Groups
  Description
Part A-Placebo Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 gram (g) kit twice daily (BID) for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 milliliter (mL) of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) prior to breakfast (morning) and 10 g (2 unit) prior to dinner (evening). On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 milligram (mg) immediate release (IR) tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
Part A-GSK2890457 Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
Part B-Placebo+Liraglutide Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 milligram (mg) once daily by subcutaneous injection during the Treatment period along with placebo.
Part B-GSK2890457+Liraglutide Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
Part C-Placebo+Metformin Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
Part C-GSK2890457+Metformin Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.

Participant Flow:   Overall Study
    Part A-Placebo   Part A-GSK2890457   Part B-Placebo+Liraglutide   Part B-GSK2890457+Liraglutide   Part C-Placebo+Metformin   Part C-GSK2890457+Metformin
STARTED   4   11   6   14   6   12 
COMPLETED   4   10   6   13   6   12 
NOT COMPLETED   0   1   0   1   0   0 
Protocol Violation                0                1                0                0                0                0 
Withdrawal by Subject                0                0                0                1                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
Part A-Placebo Healthy participants received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, matching placebo to GSK2890457 was given in the evening.
Part A-GSK2890457 Healthy participants received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. On Day 1 and 42, after overnight fasting, participants received 500 mg IR tablet of metformin just before breakfast. On Day 1 (5 g) and Day 42, GSK2890457 was given in the evening.
Part B-Placebo+Liraglutide Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 milligram (mg) once daily by subcutaneous injection during the Treatment period along with placebo.
Part B-GSK2890457+Liraglutide Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants received liraglutide up to 1.8 mg once daily by subcutaneous injection during the Treatment period along with GSK2890457.
Part C-Placebo+Metformin Participants with T2D, received oral dose of matching placebo to GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5 g placebo kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. Participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2, dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with placebo, taken one hour prior to placebo as once daily or BID.
Part C-GSK2890457+Metformin Participants with T2D, received oral dose of GSK2890457 as units of 5 g kit BID for 6 weeks. Each unit of 5g kit contained 3 sachets of powder and a bottle containing 3 capsules. The powder was mixed with 12 ounces of flavored water, capsules were taken with 120-240 mL of water. The participants were titrated up from 15 g to 40 g over a 7 day period, if tolerated. On Day 2 the dose was 15 g, taken 5 g (1 unit) in morning and 10 g (2 unit) in evening. On Day 4, 15 g (3 unit doses) in morning and 15 g (3 unit doses) in evening. On Day 7, 20 g (4 unit doses) in morning and 20 g (4 unit doses) in evening. Participants continued their usual dose of metformin during the treatment period along with GSK2890457, taken one hour prior to GSK2890457 as once daily or BID.
Total Total of all reporting groups

Baseline Measures
   Part A-Placebo   Part A-GSK2890457   Part B-Placebo+Liraglutide   Part B-GSK2890457+Liraglutide   Part C-Placebo+Metformin   Part C-GSK2890457+Metformin   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   11   6   14   6   12   53 
Age, Customized 
[Units: Participants]
Count of Participants
             
18 to 70 years   4   11   6   14   6   12   53 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      1  25.0%      1   9.1%      3  50.0%      3  21.4%      3  50.0%      4  33.3%      15  28.3% 
Male      3  75.0%      10  90.9%      3  50.0%      11  78.6%      3  50.0%      8  66.7%      38  71.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
             
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1  25.0%      6  54.5%      1  16.7%      1   7.1%      0   0.0%      2  16.7%      11  20.8% 
White      3  75.0%      5  45.5%      5  83.3%      13  92.9%      6 100.0%      10  83.3%      42  79.2% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE) or Death During Part A   [ Time Frame: Up to Follow-up (8 weeks) ]

2.  Primary:   Number of Participants With Any AE, SAE or Death During Part B and Part C   [ Time Frame: Up to Follow-up (8 weeks) ]

3.  Primary:   Number of Participants With Any Hypoglycemic Events During Part A   [ Time Frame: Up to Follow-up (8 weeks) ]

4.  Primary:   Number of Participants With Any Hypoglycemic Events During Part B and Part C   [ Time Frame: Up to Follow-up (8 weeks) ]

5.  Primary:   Change From Baseline in Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), ALT, Aspartate Aminotransferase (AST) and Gamma Glutamyltransferase (GGT) During Double-blind Treatment Period of Part A   [ Time Frame: Baseline (Day 1, Randomization) up to Day 42 ]

6.  Primary:   Change From Baseline in Clinical Chemistry Parameters of ALP, ALT, AST and GGT During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) up to Day 42 ]

7.  Primary:   Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic and Urea/Blood Urea Nitrogen (BUN) During the Double-blind Treatment Period of Part A   [ Time Frame: Baseline (Day 1, Randomization) up to Day 42 ]

8.  Primary:   Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic, BUN and Cholesterol During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) up to Day 42 ]

9.  Primary:   Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part A   [ Time Frame: Baseline (Day 1, Randomization) up to Day 42 ]

10.  Primary:   Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) up to Day 42 ]

11.  Primary:   Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part A   [ Time Frame: Baseline (Day 1, Randomization) up to Day 42 ]

12.  Primary:   Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) up to Day 42 ]

13.  Primary:   Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part A   [ Time Frame: Baseline (Day 1, Randomization) up to Day 42 ]

14.  Primary:   Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) up to Day 42 ]

15.  Primary:   Change From Baseline in Clinical Chemistry Parameters of Amylase and Lipase the Double-blind Treatment Period of Part B of Study   [ Time Frame: Baseline (Day -1) and Day 42 ]

16.  Primary:   Change From Baseline in Clinical Chemistry Parameter of Triiodothyronine (T3) Uptake During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) and Day 42 ]

17.  Primary:   Change From Baseline in Clinical Chemistry Parameters of Total Thyroxine and Total T3 During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) and Day 42 ]

18.  Primary:   Change From Baseline in Clinical Chemistry Parameters of Thyroid Stimulating Hormone During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) up to Day 42 ]

19.  Primary:   Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count During the Double-blind Treatment Period of Part A   [ Time Frame: Baseline (Day 1, Randomization) up to Day 42 ]

20.  Primary:   Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) up to Day 42 ]

21.  Primary:   Change From Baseline in Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) During the Double-blind Treatment Period of Part A   [ Time Frame: Baseline (Day 1, Randomization) up to Day 42 ]

22.  Primary:   Change From Baseline in Hematology Parameters of Hemoglobin and MCHC During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) up to Day 42 ]

23.  Primary:   Change From Baseline in Hematology Parameters of Red Blood Cell (RBC) Count and Reticulocytes During the Double-blind Treatment Period of Part A   [ Time Frame: Baseline (Day 1, Randomization) up to Day 42 ]

24.  Primary:   Change From Baseline in Hematology Parameters of RBC Count and Reticulocytes During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) up to Day 42 ]

25.  Primary:   Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part A   [ Time Frame: Baseline (Day 1, Randomization) up to Day 42 ]

26.  Primary:   Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) up to Day 42 ]

27.  Primary:   Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) During the Double-blind Treatment Period of Part A   [ Time Frame: Baseline (Day 1, Randomization) up to Day 42 ]

28.  Primary:   Change From Baseline in Hematology Parameter of MCH During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) up to Day 42 ]

29.  Primary:   Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) During the Double-blind Treatment Period of Part A   [ Time Frame: Baseline (Day 1, Randomization) up to Day 42 ]

30.  Primary:   Change From Baseline in Hematology Parameter of MCV During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) up to Day 42 ]

31.  Primary:   Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part A   [ Time Frame: Up to Day 42 ]

32.  Primary:   Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part B   [ Time Frame: Up to Day 42 ]

33.  Primary:   Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part C   [ Time Frame: Up to Day 42 ]

34.  Primary:   Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part A   [ Time Frame: Up to Day 42 ]

35.  Primary:   Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part B and C   [ Time Frame: Up to Day 42 ]

36.  Primary:   Mean pH Values of Urine During the Double-blind Treatment Period of Part A   [ Time Frame: up to Day 42 ]

37.  Primary:   Mean pH Values of Urine During the Double-blind Treatment Period of Part B and C   [ Time Frame: Up to Day 42 ]

38.  Primary:   Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During the Double-blind Treatment Period of Part A   [ Time Frame: Baseline (Day 1, Randomization) up to Day 42 ]

39.  Primary:   Change From Baseline in Vital Sign Parameter of SBP and DBP During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) up to Day 42 ]

40.  Primary:   Change From Baseline in Vital Sign Parameter of Heart Rate (HR) During the Double-blind Treatment Period of Part A   [ Time Frame: Baseline (Day 1, Randomization) up to Day 42 ]

41.  Primary:   Change From Baseline in Vital Sign Parameter of HR During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) up to Day 42 ]

42.  Primary:   Change From Baseline in Electrocardiogram (ECG) Intervals During Part A   [ Time Frame: Baseline (Day 1, Randomization) up to Follow-up (Day 56) ]

43.  Primary:   Change From Baseline in ECG Intervals During Part B and C   [ Time Frame: Baseline (Day -1) up to Follow-up (Day 56) ]

44.  Primary:   Change From Baseline in the Overall Gastrointestinal (GI) Symptoms Rating Scale (GSRS) Score During the Double-blind Treatment Period of Part A   [ Time Frame: Baseline (Day 1, Randomization) up to Day 42 ]

45.  Primary:   Change From Baseline in the Overall GSRS Score During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -2) up to Day 41 ]

46.  Primary:   Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1 and Day 1) up to Day 42 ]

47.  Primary:   Percent Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1 and Day 1) up to Day 42 ]

48.  Primary:   Change From Baseline in Weighted Mean Glucose Area Under the Curves From Time 0 to 24 Hours (AUC [0-24 Hours]) During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) and Day 42 ]

49.  Primary:   Change From Baseline in Fasting Glucose During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) and Day 42 of Part B and C ]

50.  Primary:   Change From Baseline in Fasting Insulin and Weighted Mean Insulin AUC (0-4 Hour) and AUC (0-24 Hour) During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) and Day 42 ]

51.  Primary:   Change From Baseline in Glycated Hemoglobin (HbA1c) During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) and Day 42 ]

52.  Primary:   Change From Baseline in Homeostasis Model of Assessment–Insulin Resistance (HOMA-IR]) During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) and Day 42 ]

53.  Primary:   Change From Baseline in Matsuda Index During the Double Blind-treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) and Day 42 ]

54.  Primary:   Change From Baseline in Fasting Plasma Glucose (Safety Laboratory) Values During the Double-blind Treatment Period of Part B and C   [ Time Frame: Baseline (Day -1) up to Follow-up (Day 56) ]

55.  Secondary:   Area Under Plasma Concentration From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of Liraglutide During the Double-blind Treatment Period of Part B   [ Time Frame: Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose ]

56.  Secondary:   Maximum Observed Concentration (Cmax) of Liraglutide During the Double-blind Treatment Period of Part B   [ Time Frame: Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose ]

57.  Secondary:   Time of Occurrence of Cmax (Tmax) of Liraglutide During the Double-blind Treatment Period of Part B   [ Time Frame: Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose ]

58.  Secondary:   AUC of Metformin From Time 0 to 10 Hours Post-dose (AUC [0-10 Hour]) During the Double-blind Treatment Period of Part A   [ Time Frame: Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose ]

59.  Secondary:   Cmax of Metformin During the Double-blind Treatment Period of Part A   [ Time Frame: Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose ]

60.  Secondary:   Tmax of Metformin During the Double-blind Treatment Period of Part A   [ Time Frame: Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose ]

61.  Secondary:   AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of Metformin During the Double-blind Treatment Period of Part C   [ Time Frame: Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose ]

62.  Secondary:   Cmax of Metformin During the Double-blind Treatment Period of Part C   [ Time Frame: Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose ]

63.  Secondary:   Tmax of Metformin During the Double-blind Treatment Period of Part C   [ Time Frame: Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01725126     History of Changes
Other Study ID Numbers: 116623
First Submitted: November 8, 2012
First Posted: November 12, 2012
Results First Submitted: August 17, 2017
Results First Posted: October 23, 2017
Last Update Posted: October 23, 2017