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

NCT ID: NCT00518115

Last Updated: 2016-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 361 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-05-31

Brief Summary

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.

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

GLP-1,; Type 2 Diabetes,; pharmacokinetics,; pharmacodynamics,; GSK716155,; metformin,; exenatide; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Albiglutide (GSK716155) or exenatide

Albiglutide weekly subcutaneous injection or exenatide twice daily injection

Intervention Type: DRUG

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Anniston, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Mobile, Alabama, United States

GSK Investigational Site

Bull Shoals, Arizona, United States

GSK Investigational Site

Glendale, Arizona, United States

GSK Investigational Site

Jonesboro, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Harrisburg, Arkansas, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Searcy, Arkansas, United States

GSK Investigational Site

Castro Valley, California, United States

GSK Investigational Site

Culver City, California, United States

GSK Investigational Site

Fullerton, California, United States

GSK Investigational Site

Garden Grove, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Huntington Park, California, United States

GSK Investigational Site

Lake Forest, California, United States

GSK Investigational Site

Loma Linda, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Orange, California, United States

GSK Investigational Site

Redwood City, California, United States

GSK Investigational Site

Reedley, California, United States

GSK Investigational Site

Riverside, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

Torrance, California, United States

GSK Investigational Site

Van Buys, California, United States

GSK Investigational Site

Ventura, California, United States

GSK Investigational Site

Victorville, California, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Trumbull, Connecticut, United States

GSK Investigational Site

Bradenton, Florida, United States

GSK Investigational Site

Clearwater, Florida, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Gainesville, Florida, United States

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

Marianna, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Oviedo, Florida, United States

GSK Investigational Site

Palm Harbor, Florida, United States

GSK Investigational Site

Plantation, Florida, United States

GSK Investigational Site

Tallahassee, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Winter Haven, Florida, United States

GSK Investigational Site

Winter Park, Florida, United States

GSK Investigational Site

Athens, Georgia, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Augusta, Georgia, United States

GSK Investigational Site

Columbus, Georgia, United States

GSK Investigational Site

Decatur, Georgia, United States

GSK Investigational Site

Perry, Georgia, United States

GSK Investigational Site

Suwanee, Georgia, United States

GSK Investigational Site

Tucker, Georgia, United States

GSK Investigational Site

Honolulu, Hawaii, United States

GSK Investigational Site

Meridian, Idaho, United States

GSK Investigational Site

Aurora, Illinois, United States

GSK Investigational Site

Evergreen Park, Illinois, United States

GSK Investigational Site

La Grange, Illinois, United States

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Libertyville, Illinois, United States

GSK Investigational Site

Oak Brook, Illinois, United States

GSK Investigational Site

Watseka, Illinois, United States

GSK Investigational Site

Anderson, Indiana, United States

GSK Investigational Site

Indianapolis, Indiana, United States

GSK Investigational Site

South Bend, Indiana, United States

GSK Investigational Site

South Bend, Indiana, United States

GSK Investigational Site

Ames, Iowa, United States

GSK Investigational Site

Dubuque, Iowa, United States

GSK Investigational Site

Kansas City, Kansas, United States

GSK Investigational Site

Topeka, Kansas, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Covington, Louisiana, United States

GSK Investigational Site

Lacombe, Louisiana, United States

GSK Investigational Site

Metairie, Louisiana, United States

GSK Investigational Site

Haverhill, Massachusetts, United States

GSK Investigational Site

Caro, Michigan, United States

GSK Investigational Site

Dearborn, Michigan, United States

GSK Investigational Site

Kalamazoo, Michigan, United States

GSK Investigational Site

Picayune, Mississippi, United States

GSK Investigational Site

Rolling Fork, Mississippi, United States

GSK Investigational Site

City of Saint Peters, Missouri, United States

GSK Investigational Site

Jefferson City, Missouri, United States

GSK Investigational Site

Springfield, Missouri, United States

GSK Investigational Site

Billings, Montana, United States

GSK Investigational Site

Lincoln, Nebraska, United States

GSK Investigational Site

North Platte, Nebraska, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Buffalo, New York, United States

GSK Investigational Site

Glens Falls, New York, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Williamsville, New York, United States

GSK Investigational Site

Asheville, North Carolina, United States

GSK Investigational Site

Chadbourn, North Carolina, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Greensboro, North Carolina, United States

GSK Investigational Site

Mint Hill, North Carolina, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Wilmington, North Carolina, United States

GSK Investigational Site

Winston-Salem, North Carolina, United States

GSK Investigational Site

Bismarck, North Dakota, United States

GSK Investigational Site

Bismarck, North Dakota, United States

GSK Investigational Site

Fargo, North Dakota, United States

GSK Investigational Site

Fargo, North Dakota, United States

GSK Investigational Site

Grand Forks, North Dakota, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

Toledo, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Bend, Oregon, United States

GSK Investigational Site

Bensalem, Pennsylvania, United States

GSK Investigational Site

Harrisburg, Pennsylvania, United States

GSK Investigational Site

Morrisville, Pennsylvania, United States

GSK Investigational Site

Uniontown, Pennsylvania, United States

GSK Investigational Site

Watertown, South Dakota, United States

GSK Investigational Site

Bristol, Tennessee, United States

GSK Investigational Site

Clarksville, Tennessee, United States

GSK Investigational Site

Johnson City, Tennessee, United States

GSK Investigational Site

Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

GSK Investigational Site

Milan, Tennessee, United States

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Nashville, Tennessee, United States

GSK Investigational Site

Cleburne, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Euless, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

LaPorte, Texas, United States

GSK Investigational Site

Lewisville, Texas, United States

GSK Investigational Site

Longview, Texas, United States

GSK Investigational Site

Midland, Texas, United States

GSK Investigational Site

Missouri City, Texas, United States

GSK Investigational Site

Pasadena, Texas, United States

GSK Investigational Site

Pearland, Texas, United States

GSK Investigational Site

Pharr, Texas, United States

GSK Investigational Site

Round Rock, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

San Marcos, Texas, United States

GSK Investigational Site

Spring, Texas, United States

GSK Investigational Site

Sugar Land, Texas, United States

GSK Investigational Site

The Woodlands, Texas, United States

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Tomball, Texas, United States

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Salt Lake City, Utah, United States

GSK Investigational Site

South Burlington, Vermont, United States

GSK Investigational Site

Chester, Virginia, United States

GSK Investigational Site

Manassas, Virginia, United States

GSK Investigational Site

Salem, Virginia, United States

GSK Investigational Site

Madison, Washington, United States

GSK Investigational Site

Spokane, Washington, United States

GSK Investigational Site

Concepción, Región Del Biobio, Chile

GSK Investigational Site

Buin, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santo Domingo, , Dominican Republic

Countries

Mexico; Peru; United States; Chile; Dominican Republic

References

Rosenstock J, Reusch J, Bush M, Yang F, Stewart M; Albiglutide Study Group. Potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2 diabetes: a randomized controlled trial exploring weekly, biweekly, and monthly dosing. Diabetes Care. 2009 Oct;32(10):1880-6. doi: 10.2337/dc09-0366. Epub 2009 Jul 10.

Reference Type: BACKGROUND

PMID: 19592625 (View on PubMed)

Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.

Reference Type: DERIVED

PMID: 25387217 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Dataset Specification

View Document

Document Type: Annotated Case Report Form

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

GLP110125

Identifier Type: -

Identifier Source: org_study_id