Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00518115
First received: August 17, 2007
Last updated: June 19, 2014
Last verified: May 2014
  Purpose

This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only. This study will investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will measure the levels of Albiglutide (GSK716155) in the bloodstream when it is given for 16 weeks. As a comparison, some subjects will receive exenatide instead of Albiglutide (GSK716155). The study will involve weekly visits for 17 weeks,and less frequent follow-up visits for an additional 10 weeks. Assessments include repeat blood sampling and monitoring of any side effects.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Albiglutide (GSK716155) or exenatide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 16-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Multiple Doses and Multiple Treatment Regimens of GSK716155, With Byetta as an Open Label Active Reference, in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 16 minus the value at Baseline. Based on ANCOVA: Change = treatment + Baseline HbA1c + prior therapy + gender + region. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.


Secondary Outcome Measures:
  • Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16 [ Time Frame: Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16 ] [ Designated as safety issue: No ]
    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

  • Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16 [ Time Frame: Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16 ] [ Designated as safety issue: No ]
    The number of participants who achieved target values for HbA1c (i.e., HbA1c <6.5% and >=6.5% to <7%) were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

  • Change From Baseline in Waist Circumference at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in waist circumference was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

  • Change From Baseline in Body Weight at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

  • Percent Change From Baseline in Body Weight at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. Percent change from Baseline was calculated as the ([value at Week 16 minus the Baseline value] divided by the Baseline value) multiplied by 100. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16 [ Time Frame: Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16 ] [ Designated as safety issue: No ]
    The FPG test measures blood sugar levels after the participant has not eaten (fasted) for at least eight hours prior to the sampling. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FPG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

  • Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16 [ Time Frame: Baseline and Weeks 5, 8, 12, and 16 ] [ Designated as safety issue: No ]
    Fasting fructosamine levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline fructosamine value is the last non-missing value before the start of treatment. Change from Baseline in fructosamine was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

  • Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16 [ Time Frame: Baseline and Weeks 5, 8, 12, and 16 ] [ Designated as safety issue: No ]
    Fasting C-peptide levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline C-peptide value is the last non-missing value before the start of treatment. Change from Baseline in C-peptide was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

  • Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16 [ Time Frame: Baseline and Weeks 5, 8, 12, and 16 ] [ Designated as safety issue: No ]
    Fasting glucagon levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline glucagon value is the last non-missing value before the start of treatment. Change from Baseline in glucagon was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

  • Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16 [ Time Frame: Baseline and Weeks 5, 8, 12, and 16 ] [ Designated as safety issue: No ]
    Fasting insulin levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline insulin value is the last non-missing value before the start of treatment. Change from Baseline in insulin was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

  • Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16 [ Time Frame: Baseline and Weeks 5, 8, 12, and 16 ] [ Designated as safety issue: No ]
    Serum lipid components, including triglycerides (TG), free fatty acids (FFA), total cholesterol (CL), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), were measured at Baseline and Weeks 5, 8, 12, and 16. The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

  • Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The FLIE questionnaire is used to record the participant's feelings/opinions concerning the effects of nausea/vomiting on their quality of life during the past five days. Participants completed the questionnaire by responding to 18 questions. The first set of 9 questions refer to nausea, and the second set of 9 questions refer to vomiting. Each question is scored on a seven-point visual analog scale (1 to 7). On this scale, a score of 1 corresponds to 0 millimeters (mm), and a score of 7 correspond to 100 mm. Anything in between is marked at the appropriate point on the scale and is measured in mm. Data are reported in mm in this table. In FLIE questions (FLIEQ) 1, 2, 4, 5, 7, 8, 9, 10, 12, 13, 14, 16, and 17, a score of 1 indicates no effect on the quality of life, and a score of 7 indicates a great effect on the quality of life. In FLIEQ 3, 6, 11, 15, and 18, a score of 1 indicates a great effect on the quality of life, and a score of 7 indicates no effect on the quality of life.

  • Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    The HCFQ questionnaire is used to record how often participants have felt hungry or craved food, and how full participants felt after finishing meals, on average, in the past week. Participants answered the following seven questions with the response that best described their feelings of hunger, craving, and fullness: Q1, "In the past week I was hungry"; Q2, "In the past week I thought about food"; Q3, "In the past week I wanted to eat"; Q4, "In the past week I ate more than I should have"; Q5, "In the past week, I craved specific food"; Q6, "In the past week when finished meals I felt full"; Q7, "In the past week when finished meals I felt satisfied."

  • Mean Clearance of Albiglutide [ Time Frame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27 ] [ Designated as safety issue: No ]
    Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose pharmacokinetic (PK) sampling was performed within 6 days of drug administration.

  • Mean Volume of Distribution of Albiglutide [ Time Frame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27 ] [ Designated as safety issue: No ]
    Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.

  • Mean Absorption Rate of Albiglutide [ Time Frame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27 ] [ Designated as safety issue: No ]
    Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.

  • Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG [ Time Frame: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27 ] [ Designated as safety issue: No ]
    EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.


Enrollment: 361
Study Start Date: April 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Albiglutide (GSK716155) or exenatide
    Albiglutide weekly subcutaneous injection or exenatide twice daily injection
    Other Name: Albiglutide (GSK716155) or exenatide
Detailed Description:

A 16-week, parallel-group, double-blind, randomized, placebo-controlled, multicenter, dose-ranging study to evaluate the efficacy, safety and tolerability of multiple doses and multiple treatment regimens of Albiglutide (GSK716155) with Byetta as an open-label active reference, in subjects with Type 2 Diabetes Mellitus.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has type 2 diabetes mellitus as defined by the criteria of the American Diabetes Association and recognized by World Health Organization Expert Committee on the Diagnosis and Classification of Diabetes Mellitus [American Diabetes Association, 2004a] at least three months preceding screening
  • Has concurrent type 2 diabetes mellitus therapy: Must be diet and exercise treated; must not have taken antidiabetic medication for at least three months prior to prescreening or Monotherapy with metformin, with a history of a stable dose for at least three months before prescreening (not taking more than one oral antidiabetic agent)
  • Has HbA1c level at screening ≥7 and ≤10%
  • Is male or female 18 to 75 years of age, inclusive, at screening
  • Has body mass index ≥20 and ≤40 kg/m²
  • If subject is a smoker, must be able to abstain while in clinic at each visit
  • If female, is eligible to enter and participate throughout the study, including the follow-up period: 1) If of nonchildbearing potential (i.e. physiologically incapable of becoming pregnant {tubal ligation}, including any female who is postmenopausal [>1 year without menstrual period]); or, 2) If of childbearing potential, has negative pregnancy tests at screening (serum) and at baseline (urine) and: 3) Has a male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or 4) Uses double-barrier methods of contraception; condoms (with spermicide) and intrauterine devices are acceptable, or 5) Uses hormonal contraceptives (oral, depots, patches, etc) with double-barrier methods of contraception as outlined above, or, 6) Abstains from sexual intercourse, or 7) Is with a same-sex partner and does not participate in bisexual activities where there is any risk of pregnancy
  • Signs and dates informed consent before any study-related procedures are performed

Exclusion Criteria:

  • Has metabolic disease including but not limited to: 1) Diagnosis of type 1 diabetes mellitus, 2) Uncorrected thyroid dysfunction (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least three months prior to screening, and who have a screening thyroid-stimulating hormone within the limits of normal may participate)
  • Has qualitative changes in lifestyle that, in the opinion of the investigator, would affect the subject's weight or disease status
  • Had previous use of insulin within one month prior to screening, or more than seven total days of insulin treatment within three months prior to screening
  • Has clinically significant cardiovascular and/or cerebrovascular disease including, but not limited to: 1) Previous history of stroke or transient ischemic attack, 2) Active, unstable coronary heart disease within the past six months, 3) Documented myocardial infarction within a year prior to screening 4) Any cardiac surgery including percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery within a year prior to screening 5) Unstable angina 6) Clinically significant arrhythmia or valvular heart disease within the past year 7) Congestive heart failure with New York Heart Association Class II to Class IV symptoms. Class I is acceptable. 8) Untreated hypertension, with systolic pressure greater than 160mm Hg and/or diastolic pressure greater than 95mm Hg. 9) ECG exclusion criteria: Heart rate is <40 and >110 beats per minute, PR Interval is <120 and >210msec, QRS duration is <70 and >120msec, QTc interval (Bazett) is >450msec or >480msec with bundle branch block
  • Has fasting serum triglycerides ≥800mg/dL or 9mmol/L at screening (Visit 2). Subjects receiving lipid-lowering therapy must have been on the same dose of therapy for the past three months. Fasting is defined as no food/drink for at least eight hours prior to sampling
  • If female, is currently lactating, pregnant, or actively trying to become pregnant
  • Has significant renal disease as manifested by one or more of the following: 1) Creatinine clearance <60mL/min. (estimated from serum creatinine and demographic data using the modification of diet in renal disease calculation; refer to the SPM/ISFM), 2) Urine albumin excretion ≥500 µg/mL on a urine spot check, 3) Known loss of a kidney either by surgical ablation, injury, or disease
  • Has history of significant comorbid diseases active within the last six months (e.g., gastrointestinal disease)
  • Has history of pancreatitis within five years prior to randomization
  • Has a documented history of chronic or advanced hepatobiliary disease including a history of, or positive laboratory results for, hepatitis at screening (Visit 2), and/or clinically significant hepatic enzyme elevation including: 1) Any two of the following enzymes greater than 1.5 times the upper limit of normal (ULN) value: - alanine aminotransferase (ALT), - aspartate aminotransferase (AST), - alkaline phosphatase (ALP), 2) Any one of the above enzymes two times greater than the ULN value AND total or direct bilirubin >1.5 times the ULN
  • Has a history of alcohol or substance abuse within the past year, as determined by the investigator or a positive urine drug screen at screening (Visit 2) or during treatment: 1) Unwilling to refrain from the use of excessive alcohol or illicit drugs and adhere to other protocol-stated restrictions while participating in the study, 2) History of alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than two units (females). One unit is equivalent to a half-pint of beer or one measure of spirits or one glass of wine, 2) The investigator should exercise their medical judgment to determine if a urine drug screen is indicated
  • Is currently taking prohibited concomitant medications listed in Section 6.6.2
  • Has clinically significant anemia (i.e., hemoglobin <12.0g/dL or <120.0g/L for males and <11.0g/dL or <110.0g/L for females) or any other abnormal hematological profile that is considered by the investigator to be clinically significant
  • Has known allergy to any formulation excipients, or history of drug or other allergy, which, in the opinion of the responsible study physician, contradicts participation
  • Received treatment with an investigational drug or participated in any other clinical trial during the previous 30 days
  • Has prior use of investigational agents with long half-lives of greater than seven days within the three months prior to screening
  • Has any prior use of a GLP-1 analog, including GSK716155
  • In the opinion of the investigator, has a risk of noncompliance with study procedures, or cannot read, understand, or complete study-related materials, particularly the informed consent
  • Has any concurrent condition or any clinically significant abnormality identified on the screening physical examination, laboratory tests, ECG, including pulmonary, neurological, or inflammatory diseases, which, in the opinion of the investigator, may affect the interpretation of efficacy and safety data, or which otherwise, contraindicates participation in a clinical trial with a new chemical entity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518115

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Anniston, Alabama, United States, 36207
GSK Investigational Site
Birmingham, Alabama, United States, 35233
GSK Investigational Site
Mobile, Alabama, United States, 36617
United States, Arizona
GSK Investigational Site
Bull Shoals, Arizona, United States, 72619
GSK Investigational Site
Glendale, Arizona, United States, 85306
GSK Investigational Site
Jonesboro, Arizona, United States, 72401
GSK Investigational Site
Phoenix, Arizona, United States, 85032
United States, Arkansas
GSK Investigational Site
Harrisburg, Arkansas, United States, 72432
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
GSK Investigational Site
Little Rock, Arkansas, United States, 72211-3733
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
GSK Investigational Site
Searcy, Arkansas, United States, 72143
United States, California
GSK Investigational Site
Castro Valley, California, United States, 94546
GSK Investigational Site
Culver City, California, United States, 90232
GSK Investigational Site
Fullerton, California, United States, 92835
GSK Investigational Site
Garden Grove, California, United States, 92843
GSK Investigational Site
Huntington Beach, California, United States, 92646
GSK Investigational Site
Huntington Beach, California, United States, 92648
GSK Investigational Site
Huntington Park, California, United States, 90255
GSK Investigational Site
Lake Forest, California, United States, 92630
GSK Investigational Site
Loma Linda, California, United States, 92354
GSK Investigational Site
Los Angeles, California, United States, 90022
GSK Investigational Site
Orange, California, United States, 92868
GSK Investigational Site
Redwood City, California, United States, 94062
GSK Investigational Site
Reedley, California, United States, 93654
GSK Investigational Site
Riverside, California, United States, 92506
GSK Investigational Site
Sacramento, California, United States, 95823
GSK Investigational Site
Torrance, California, United States, 90503
GSK Investigational Site
Van Buys, California, United States, 91405
GSK Investigational Site
Ventura, California, United States, 93003
GSK Investigational Site
Victorville, California, United States, 92395
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80220
United States, Connecticut
GSK Investigational Site
Trumbull, Connecticut, United States, 06611
United States, Florida
GSK Investigational Site
Bradenton, Florida, United States, 34205
GSK Investigational Site
Clearwater, Florida, United States, 33756
GSK Investigational Site
Ft. Lauderdale, Florida, United States, 33316
GSK Investigational Site
Gainesville, Florida, United States, 32601
GSK Investigational Site
Jacksonville, Florida, United States, 32204
GSK Investigational Site
Marianna, Florida, United States, 32446
GSK Investigational Site
Miami, Florida, United States, 33144
GSK Investigational Site
Oviedo, Florida, United States, 32765
GSK Investigational Site
Palm Harbor, Florida, United States, 34684
GSK Investigational Site
Plantation, Florida, United States, 33317
GSK Investigational Site
Tallahassee, Florida, United States, 32308
GSK Investigational Site
Tampa, Florida, United States, 33603
GSK Investigational Site
Winter Haven, Florida, United States, 33881
GSK Investigational Site
Winter Park, Florida, United States, 32789
United States, Georgia
GSK Investigational Site
Athens, Georgia, United States, 30606
GSK Investigational Site
Atlanta, Georgia, United States, 30338
GSK Investigational Site
Atlanta, Georgia, United States, 30308
GSK Investigational Site
Atlanta, Georgia, United States, 30312
GSK Investigational Site
Augusta, Georgia, United States, 30909
GSK Investigational Site
Columbus, Georgia, United States, 31904
GSK Investigational Site
Decatur, Georgia, United States, 30032
GSK Investigational Site
Perry, Georgia, United States, 31069
GSK Investigational Site
Suwanee, Georgia, United States, 30024
GSK Investigational Site
Tucker, Georgia, United States, 30084
United States, Hawaii
GSK Investigational Site
Honolulu, Hawaii, United States, 96813
United States, Idaho
GSK Investigational Site
Meridian, Idaho, United States, 83642
United States, Illinois
GSK Investigational Site
Aurora, Illinois, United States, 60504
GSK Investigational Site
Evergreen Park, Illinois, United States, 60805
GSK Investigational Site
La Grange, Illinois, United States, 60525
GSK Investigational Site
Libertyville, Illinois, United States, 60048
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
GSK Investigational Site
Watseka, Illinois, United States, 60970
United States, Indiana
GSK Investigational Site
Anderson, Indiana, United States, 46011
GSK Investigational Site
Indianapolis, Indiana, United States, 46256
GSK Investigational Site
South Bend, Indiana, United States, 46628
GSK Investigational Site
South Bend, Indiana, United States, 46601
United States, Iowa
GSK Investigational Site
Ames, Iowa, United States, 50010
GSK Investigational Site
Dubuque, Iowa, United States, 52002
United States, Kansas
GSK Investigational Site
Kansas City, Kansas, United States, 66160
GSK Investigational Site
Topeka, Kansas, United States, 66606
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40504
United States, Louisiana
GSK Investigational Site
Covington, Louisiana, United States, 70433
GSK Investigational Site
Lacombe, Louisiana, United States, 70433
GSK Investigational Site
Metairie, Louisiana, United States, 70006
United States, Massachusetts
GSK Investigational Site
Haverhill, Massachusetts, United States, 01831-2451
United States, Michigan
GSK Investigational Site
Caro, Michigan, United States, 48723
GSK Investigational Site
Dearborn, Michigan, United States, 48126
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
United States, Mississippi
GSK Investigational Site
Picayune, Mississippi, United States, 39446
GSK Investigational Site
Rolling Fork, Mississippi, United States, 39159
United States, Missouri
GSK Investigational Site
Jefferson City, Missouri, United States, 65109
GSK Investigational Site
Springfield, Missouri, United States, 65807
GSK Investigational Site
St. Peters, Missouri, United States, 63376
United States, Montana
GSK Investigational Site
Billings, Montana, United States, 59101
United States, Nebraska
GSK Investigational Site
Lincoln, Nebraska, United States, 68516
GSK Investigational Site
North Platte, Nebraska, United States, 69101
GSK Investigational Site
Omaha, Nebraska, United States, 68152
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89106
GSK Investigational Site
Las Vegas, Nevada, United States, 89128
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14209
GSK Investigational Site
Glens Falls, New York, United States, 12801
GSK Investigational Site
Rochester, New York, United States, 14609
GSK Investigational Site
Syracuse, New York, United States, 13210
GSK Investigational Site
Williamsville, New York, United States, 14221
United States, North Carolina
GSK Investigational Site
Asheville, North Carolina, United States, 28801
GSK Investigational Site
Chadbourn, North Carolina, United States, 28431
GSK Investigational Site
Charlotte, North Carolina, United States, 28227
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
GSK Investigational Site
Greensboro, North Carolina, United States, 27455
GSK Investigational Site
Mint Hill, North Carolina, United States, 28227
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
GSK Investigational Site
Bismarck, North Dakota, United States, 58503
GSK Investigational Site
Bismarck, North Dakota, United States, 58504
GSK Investigational Site
Fargo, North Dakota, United States, 58122
GSK Investigational Site
Fargo, North Dakota, United States, 58104
GSK Investigational Site
Grand Forks, North Dakota, United States, 58201
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44122
GSK Investigational Site
Columbus, Ohio, United States, 43235
GSK Investigational Site
Toledo, Ohio, United States, 43606
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
GSK Investigational Site
Bend, Oregon, United States, 97701
United States, Pennsylvania
GSK Investigational Site
Bensalem, Pennsylvania, United States, 19020
GSK Investigational Site
Harrisburg, Pennsylvania, United States, 17112
GSK Investigational Site
Morrisville, Pennsylvania, United States, 19067
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
United States, South Dakota
GSK Investigational Site
Watertown, South Dakota, United States, 57201
United States, Tennessee
GSK Investigational Site
Bristol, Tennessee, United States, 37620
GSK Investigational Site
Clarksville, Tennessee, United States, 37043
GSK Investigational Site
Johnson City, Tennessee, United States, 37604
GSK Investigational Site
Knoxville, Tennessee, United States, 37923
GSK Investigational Site
Memphis, Tennessee, United States, 38119
GSK Investigational Site
Milan, Tennessee, United States, 38358
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
Cleburne, Texas, United States, 76033
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
Euless, Texas, United States, 76040
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
Houston, Texas, United States, 77006
GSK Investigational Site
Houston, Texas, United States, 77056
GSK Investigational Site
Houston, Texas, United States, 77070
GSK Investigational Site
Houston, Texas, United States, 77082
GSK Investigational Site
LaPorte, Texas, United States, 77571
GSK Investigational Site
Lewisville, Texas, United States, 75067
GSK Investigational Site
Longview, Texas, United States, 75605
GSK Investigational Site
Midland, Texas, United States, 79707
GSK Investigational Site
Missouri City, Texas, United States, 77459
GSK Investigational Site
Pasadena, Texas, United States, 77504
GSK Investigational Site
Pearland, Texas, United States, 77584
GSK Investigational Site
Pharr, Texas, United States, 78577
GSK Investigational Site
Round Rock, Texas, United States, 78664
GSK Investigational Site
San Antonio, Texas, United States, 78205
GSK Investigational Site
San Marcos, Texas, United States, 78666
GSK Investigational Site
Spring, Texas, United States, 77379
GSK Investigational Site
Sugar Land, Texas, United States, 77478
GSK Investigational Site
The Woodlands, Texas, United States, 77381
GSK Investigational Site
Tomball, Texas, United States, 77375
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Vermont
GSK Investigational Site
South Burlington, Vermont, United States, 05403
United States, Virginia
GSK Investigational Site
Chester, Virginia, United States, 23836
GSK Investigational Site
Manassas, Virginia, United States, 20110
GSK Investigational Site
Salem, Virginia, United States, 24153
United States, Washington
GSK Investigational Site
Madison, Washington, United States, 53717
GSK Investigational Site
Spokane, Washington, United States, 99204
Chile
GSK Investigational Site
Concepcion, Región Del Biobio, Chile, 4070038
GSK Investigational Site
Buin, Región Metro De Santiago, Chile, 9500645
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500010
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 8320268
Dominican Republic
GSK Investigational Site
Santo Domingo, Dominican Republic
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00518115     History of Changes
Other Study ID Numbers: GLP110125
Study First Received: August 17, 2007
Results First Received: May 1, 2014
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GLP-1,
Type 2 Diabetes,
pharmacokinetics,
pharmacodynamics,
GSK716155,
metformin,
exenatide
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Metformin
Albiglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 20, 2014