A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes
This study is ongoing, but not recruiting participants.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00839527
First received: February 5, 2009
Last updated: January 21, 2013
Last verified: November 2012
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Purpose
The purpose of this study is to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: metformin + glimepiride + pioglitazone + albiglutide placebo Biological: metformin + glimepiride + pioglitazone placebo + albiglutide Drug: metformin + glimepiride + pioglitazone placebo + albiglutide placebo |
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- and Active-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone. |
Resource links provided by NLM:
Drug Information available for:
Metformin
Metformin hydrochloride
Glimepiride
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: | 685 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | March 2013 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: metformin + glimepiride + pioglitazone + albiglutide placebo
Metformin + glimepiride + pioglitazone + matching albiglutide placebo
|
Drug: metformin + glimepiride + pioglitazone + albiglutide placebo
metformin + open-label glimepiride + pioglitazone + albiglutide matching placebo
|
|
Experimental: metformin + glimepiride + pioglitazone placebo + albiglutide
Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide
|
Biological: metformin + glimepiride + pioglitazone placebo + albiglutide
metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide
|
|
Active Comparator: met + glimepiride + pioglitazone placebo + albiglutide placebo
metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo
|
Drug: metformin + glimepiride + pioglitazone placebo + albiglutide placebo
metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide matching placebo
|
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 inclusive
Exclusion Criteria:
- females who are pregnant, lactating, or less than 6 weeks post-partum
- current symptomatic heart failure (NYHA Class II-IV)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839527
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| Fort Worth, Texas, United States, 76135 | |
| GSK Investigational Site | |
| Fort Worth, Texas, United States, 76104 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77030 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77074 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77055 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77058 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77036 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77024 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77034 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77070 | |
| GSK Investigational Site | |
| Hurst, Texas, United States, 76054 | |
| GSK Investigational Site | |
| Katy, Texas, United States, 77450 | |
| GSK Investigational Site | |
| Lake Jackson, Texas, United States, 77566 | |
| GSK Investigational Site | |
| Lewisville, Texas, United States, 75067 | |
| GSK Investigational Site | |
| Midland, Texas, United States, 79707 | |
| GSK Investigational Site | |
| North Richland Hills, Texas, United States, 76180 | |
| GSK Investigational Site | |
| Odessa, Texas, United States, 79761 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78217 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78258 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78218 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78215 | |
| 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 | |
| GSK Investigational Site | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| GSK Investigational Site | |
| Orem, Utah, United States, 84058 | |
| GSK Investigational Site | |
| Salt Lake City, Utah, United States, 84102 | |
| 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 | |
| Virgina Beach, Virginia, United States, 23455 | |
| 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 | |
| Germany | |
| GSK Investigational Site | |
| Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78054 | |
| GSK Investigational Site | |
| Kuenzing, Bayern, Germany, 94550 | |
| GSK Investigational Site | |
| Kelkheim, Hessen, Germany, 65779 | |
| GSK Investigational Site | |
| Rotenburg, Hessen, Germany, 36199 | |
| GSK Investigational Site | |
| Bad Lauterberg, Niedersachsen, Germany, 37431 | |
| GSK Investigational Site | |
| Mainz, Rheinland-Pfalz, Germany, 55116 | |
| GSK Investigational Site | |
| Berlin, Germany, 10115 | |
| Hong Kong | |
| GSK Investigational Site | |
| Chaiwan, Hong Kong | |
| GSK Investigational Site | |
| Kwun Tong, Kowloon, Hong Kong | |
| GSK Investigational Site | |
| Shatin, Hong Kong | |
| GSK Investigational Site | |
| Tai Po,, Hong Kong | |
| India | |
| GSK Investigational Site | |
| Aurangabad, India, 431001 | |
| GSK Investigational Site | |
| Bangalore, India, 560043 | |
| GSK Investigational Site | |
| Chennai, India, 600086 | |
| GSK Investigational Site | |
| Pune, India, 411 011 | |
| GSK Investigational Site | |
| Pune, India, 411011 | |
| Peru | |
| GSK Investigational Site | |
| Callao, Lima, Peru, Callao 2 | |
| GSK Investigational Site | |
| Ica, Peru, 11 | |
| GSK Investigational Site | |
| Lima, Peru, Lima 1 | |
| GSK Investigational Site | |
| Lima, Peru, 01 | |
| Philippines | |
| GSK Investigational Site | |
| Cebu City, Philippines, 6000 | |
| GSK Investigational Site | |
| Marikina City, Philippines, 1810 | |
| GSK Investigational Site | |
| Quezon City, Philippines, 1101 | |
| GSK Investigational Site | |
| Quezon City, Philippines, 1102 | |
| GSK Investigational Site | |
| San Juan, Philippines, 1500 | |
| GSK Investigational Site | |
| Taytay Rizal, Philippines, 1920 | |
| Russian Federation | |
| GSK Investigational Site | |
| Smolensk, Russian Federation, 214 019 | |
| GSK Investigational Site | |
| Yaroslavl, Russian Federation, 150062 | |
| Spain | |
| GSK Investigational Site | |
| Alzira/Valencia, Spain, 46600 | |
| GSK Investigational Site | |
| Barcelona, Spain, 08022 | |
| GSK Investigational Site | |
| Madrid, Spain, 28034 | |
| GSK Investigational Site | |
| Palma de Mallorca, Spain, 07010 | |
| GSK Investigational Site | |
| Sevilla, Spain, 41003 | |
| United Kingdom | |
| GSK Investigational Site | |
| Blackpool, Lancashire, United Kingdom, FY4 3AD | |
| GSK Investigational Site | |
| Coventry, West Midlands, United Kingdom, CV2 2DX | |
| GSK Investigational Site | |
| Glasgow, United Kingdom, G45 9AW | |
| 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: | NCT00839527 History of Changes |
| Other Study ID Numbers: | 112757 |
| Study First Received: | February 5, 2009 |
| Last Updated: | January 21, 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 Glimepiride Pioglitazone Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013