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: February 7, 2013
Last verified: February 2013
  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: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in HbA1c after 16 weeks. [ Time Frame: 16 Weeks ]

Secondary Outcome Measures:
  • Change in HbA1c throughout the study. Evaluation of levels of GSK716155 in the blood, throughout the study. Changes in waist circumference, body weight, fasting plasma glucose, lipids, and other blood parameters after 16 weeks [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline in HbA1c over time [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Population PK and PK/PD parameters [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve HbA1c (≤6.5%, <7%) over time and at the end of the study [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in waist circumference and in percent change in body weight at Week 16 [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in FPG over time and at the end of the study [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in fasting fructosamine, fasting insulin, C-peptide, and glucagon over time and at the end of the study [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in body weight and serum lipid profile (triglycerides, free fatty acids, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol) over time and at the end of the study [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
  • The subject's feelings and opinions concerning the effects of nausea and vomiting on daily life as assessed by the Functional Living Index - Emesis over time [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Subject-reported feelings of hunger and satiety as assessed by the Hunger, Craving and Fullness Questionnaire over time [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 318
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518115

  Show 163 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00518115     History of Changes
Other Study ID Numbers: GLP110125
Study First Received: August 17, 2007
Last Updated: February 7, 2013
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014