Safety and Efficacy of Albiglutide in Type 2 Diabetes
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00849056
First received: February 19, 2009
Last updated: February 7, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of type 2 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Biological: albiglutide + pioglitazone with or without metfomin Biological: placebo + pioglitazone with or without metformin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Pioglitazone With or Without Metformin in Subjects With Type 2 Diabetes. |
Resource links provided by NLM:
Drug Information available for:
Metformin
Metformin hydrochloride
Pioglitazone
Pioglitazone hydrochloride
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- HbA1c change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]change from baseline
Secondary Outcome Measures:
- FPG change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]change from baseline
- body weight change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]change from baseline
| Enrollment: | 310 |
| Study Start Date: | January 2009 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: placebo + pioglitazone (with or without metformin)
Placebo albiglutide weekly injection + pioglitazone (with or without metformin)
|
Biological: placebo + pioglitazone with or without metformin
placebo albiglutide weekly injection + pioglitazone (with or without metformin)
|
|
Experimental: albiglutide + pioglitazone (with or without metformin)
albiglutide weekly injection + pioglitazone (+/- meformin)
|
Biological: albiglutide + pioglitazone with or without metfomin
albiglutide weekly injection + pioglitazone (with or without metformin)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- type 2 diabetes
- BMI 20-45kg/m2
Exclusion Criteria:
- NYHA Class II to IV heart failure
- females who are pregnant, lactating, or less than 6 weeks post-partum
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849056
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| San Antonio, Texas, United States, 78218 | |
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| San Antonio, Texas, United States, 78229 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78258 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78224 | |
| GSK Investigational Site | |
| Schertz, Texas, United States, 78154 | |
| GSK Investigational Site | |
| Sugar Land, Texas, United States, 77479 | |
| GSK Investigational Site | |
| Sugarland, Texas, United States, 77479 | |
| United States, Utah | |
| GSK Investigational Site | |
| Bountiful, Utah, United States, 84010 | |
| GSK Investigational Site | |
| Orem, Utah, United States, 84058 | |
| GSK Investigational Site | |
| Salt Lake City, Utah, United States, 84120 | |
| GSK Investigational Site | |
| Salt Lake City, Utah, United States, 84107 | |
| GSK Investigational Site | |
| West Jordan, Utah, United States, 84088 | |
| GSK Investigational Site | |
| West Valley City, Utah, United States, 84120 | |
| United States, Vermont | |
| GSK Investigational Site | |
| South Burlington, Vermont, United States, 05403 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Burke, Virginia, United States, 22015 | |
| GSK Investigational Site | |
| Hampton, Virginia, United States, 23666 | |
| GSK Investigational Site | |
| Manassas, Virginia, United States, 20110 | |
| GSK Investigational Site | |
| Norfolk, Virginia, United States, 23502 | |
| GSK Investigational Site | |
| Richmond, Virginia, United States, 23294 | |
| GSK Investigational Site | |
| Suffolk, Virginia, United States | |
| GSK Investigational Site | |
| Weber City, Virginia, United States, 24290 | |
| United States, Washington | |
| GSK Investigational Site | |
| Federal Way, Washington, United States, 98003 | |
| GSK Investigational Site | |
| Renton, Washington, United States, 98057 | |
| GSK Investigational Site | |
| Richland, Washington, United States, 99352 | |
| GSK Investigational Site | |
| Selah, Washington, United States, 98942 | |
| GSK Investigational Site | |
| Spokane, Washington, United States, 99216 | |
| GSK Investigational Site | |
| Spokane, Washington, United States, 99208 | |
| GSK Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| United States, West Virginia | |
| GSK Investigational Site | |
| Lewisburg, West Virginia, United States, 24901 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Milwaukee, Wisconsin, United States, 53226 | |
| India | |
| GSK Investigational Site | |
| Aurangabad, India, 431001 | |
| GSK Investigational Site | |
| Pune, India, 411011 | |
| Korea, Republic of | |
| GSK Investigational Site | |
| Seongnam-si, Korea, Republic of, 463712 | |
| GSK Investigational Site | |
| Suwon, Kyonggi-do, Korea, Republic of, 443-721 | |
| Peru | |
| GSK Investigational Site | |
| El Agustino, Lima, Peru, 10 | |
| GSK Investigational Site | |
| Huacho, Lima, Peru | |
| GSK Investigational Site | |
| Arequipa, Peru, 54 | |
| GSK Investigational Site | |
| Lima, Peru, 17 | |
| GSK Investigational Site | |
| Trujillo, Peru | |
| South Africa | |
| GSK Investigational Site | |
| Port Elizabeth, Eastern Cape, South Africa, 6014 | |
| GSK Investigational Site | |
| Phoenix, KwaZulu- Natal, South Africa, 4068 | |
| GSK Investigational Site | |
| Kempton Park, South Africa, 1619 | |
| GSK Investigational Site | |
| Somerset West, South Africa, 07129 | |
| United Kingdom | |
| GSK Investigational Site | |
| Blackpool, Lancashire, United Kingdom, FY4 3AD | |
| GSK Investigational Site | |
| Sunbury-on-Thames, Middlesex, United Kingdom, TW16 6RH | |
| GSK Investigational Site | |
| Port Glasgow, Renfrewshire, United Kingdom, PA14 6HW | |
| GSK Investigational Site | |
| Coventry, West Midlands, United Kingdom, CV2 2DX | |
| GSK Investigational Site | |
| Glasgow, United Kingdom, G45 9AW | |
| GSK Investigational Site | |
| Liverpool, United Kingdom, L9 7AL | |
| GSK Investigational Site | |
| London, United Kingdom, SE1 9NH | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00849056 History of Changes |
| Other Study ID Numbers: | 112755 |
| Study First Received: | February 19, 2009 |
| Last Updated: | February 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pioglitazone Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013