A Type 2 Diabetes Study of the Longer-Term Glycemic Effect of AVANDAMET vs. Metformin
A Randomized, Parallel Group, Double-blind, Multi-center Study Comparing the Efficacy and Safety of AVANDAMET and Metformin After 80 Weeks of Treatment.
1 other identifier
interventional
688
9 countries
116
Brief Summary
This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes. The study consists of a 2 week screening period (2 study visits), followed by an 80 week double-blind treatment period (11 study visits). Also, a sub-study was included to look at changes in bone mineral density (BMD) at the lumbar spine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus-type-2
Started Oct 2006
Longer than P75 for phase_4 diabetes-mellitus-type-2
116 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 9, 2006
CompletedFirst Posted
Study publicly available on registry
October 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
April 5, 2011
CompletedNovember 23, 2016
October 1, 2016
2.9 years
October 9, 2006
July 8, 2010
October 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in HbA1c at Week 80
Blood was taken for serum HbA1c measurements. Change from baseline was calculated as the Week 80 value minus the baseline value. Last observation carried forward (LOCF) was not used for this analysis.
Baseline and Week 80
Secondary Outcomes (28)
Mean Change From Baseline in HbA1c at Week 80
Baseline and Week 80
Number of Participants Achieving HbA1c <=6.5% and <7% at Week 80
Week 80
Change in Fasting Plasma Glucose (FPG) From Baseline at Week 80
Baseline and Week 80
Change From Baseline in FPG at Week 80
Baseline and Week 80
Number of Participants Achieving FPG <=6 mmol/L (110 mg/dL) and <=7 mmol/L (126 mg/dL) at Week 80
Week 80
- +23 more secondary outcomes
Study Arms (2)
Metformin
PLACEBO COMPARATORMET began at a total daily dose of 500 mg and could be increased up to a maximum dose of MET 2000 mg. The dose level was to be increased unless a tolerability issue existed at the current dose level.
Avandamet (Rosiglitazone maleate/metformin hydrochloride)
ACTIVE COMPARATORAVM began at a total daily dose of 4 mg/500 mg and could be increased up to a maximum dose of AVM 8 mg/2000 mg
Interventions
One 2 mg/ 500 mg capsule will be taken in the AM with the morning meal Two 2 mg/ 500 mg capsules will be taken in the PM with the evening meal
One 2 mg/500 mg capsule will be taken in the AM with the morning meal. One 2 mg/500 mg capsule will be taken in the PM with the evening meal.
one placebo capsule will be taken in the AM with the morning meal one 2 mg/ 500 mg capsule will be taken in the PM with the evening meal.
Two 2 mg/ 500 mg capsules will be taken in the AM with the morning meal. Two 2 mg/ 500 mg capsules will be taken in the PM with the evening meal.
One placebo capsule will be taken in the AM with the morning meal. One 500 mg capsule will be taken in the PM with the evening meal.
One 500 mg capsule will be taken in the AM with the morning meal. One 500 mg capsule will be taken in the PM with the evening meal.
One 500 mg capsule will be taken in the AM with the morning meal. Two 500 mg capsules will be taken in the PM with the evening meal.
Two 500 mg capsule will be taken in the AM with the morning meal. Two 500 mg capsule will be taken in the PM with the evening meal.
Eligibility Criteria
You may qualify if:
- The subject provides written informed consent.
- The subject is male or female and 18 to 75 years of age at the time of pre-screening.
- The subject has an established clinical diagnosis of type 2 diabetes according to recommended guidelines (e.g., American Diabetes Association, International Diabetes Federation, World Health Organization, Canadian Diabetes Association, or American Association of Clinical Endocrinologists).
- The subject is currently treated with diet and exercise, and has not taken more than 2 weeks of an anti-diabetic monotherapy or insulin in the past 6 months.
- The subject has a BMI \>25 kg/m2 at pre-screening.
- The subject has a Quest HbA1c 7.5% to 10.5% at pre-screening.
- The subject has a fasting capillary blood glucose 126 mg/dL (7mmol/L), as measured by the site staff at week 0.
- If the subject is a pre-menopausal female of child-bearing potential, she agrees to practice acceptable contraceptive measures (e.g. oral birth control pills, Norplant, Depo-Provera, an intrauterine device (IUD), a diaphragm with spermicide or a condom with spermicide, or abstinence) at least 1 month before screening, during the study, and for 30 days after the last dose of study medication is taken
- The subject is able and willing to perform self-monitoring of blood glucose as specified in this protocol.
You may not qualify if:
- The subject has taken an oral anti-diabetic monotherapy or insulin for more than 14 days in the past 6 months.
- The subject has presence of clinically significant renal or hepatic disease (serum creatinine 1.5 mg/dL (132.6 mol/L) for males and 1.4 mg/dL (123.8 mol/L) for females): ALT, AST, total bilirubin, or alkaline phosphatase \>2.5 times the upper limit of the normal (ULN) reference range.
- The subject has anemia defined by hemoglobin concentration \<11g/dL (110g/L) for males or \<10g/dL (100g/L) for females.
- Presence of unstable or severe angina, coronary insufficiency or New York Heart Association (NYHA) class III-IV or any congestive heart failure requiring pharmacologic treatment.
- The subject has systolic blood pressure \>160 mmHg or diastolic blood pressure \>90 mmHg
- The subject has a chronic disease requiring intermittent or chronic treatment with oral, intravenous, or intra-articular corticosteroids (i.e., only use of topical, inhaled or nasal corticosteroids is permitted).
- The subject has acute or chronic metabolic acidosis or a history of diabetic ketoacidosis.
- The subject has used an investigational agent within 30 days or 5 half-lives (whichever was longer) prior to pre-screening.
- The subject is a female who is lactating, pregnant, or planned to become pregnant.
- The subject has a prior history of severe edema or a medically serious fluid related event (e.g., heart failure).
- The subject has a history of macular edema.
- The subject has significant hypersensitivity (e.g., difficulty swallowing, difficulty breathing, and tachycardia or skin reaction) to TZDs, biguanides, or compounds with similar chemical structures.
- The subject has a diagnosis of cancer (other than squamous, basal cell, or cervical cancer in-situ) in the past 3 years and is receiving treatment for cancer.
- The subject has a history or suspicion of drug abuse or alcohol abuse within the last 6 months.
- The subject is known to have severe lactose intolerance.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (116)
GSK Investigational Site
Tuscaloosa, Alabama, 35406, United States
GSK Investigational Site
Gilbert, Arizona, 85296, United States
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Glendale, Arizona, 85308, United States
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Phoenix, Arizona, 85020, United States
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Tucson, Arizona, 85712, United States
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Tucson, Arizona, 85745, United States
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Alhambra, California, 91801, United States
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Artesia, California, 90701, United States
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Greenbrae, California, 94904, United States
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Roseville, California, 95661, United States
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Sacramento, California, 95825, United States
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Wheat Ridge, Colorado, 80033, United States
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Hialeah, Florida, 33013, United States
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Ocala, Florida, 34471, United States
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Kahului, Hawaii, 96732, United States
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Peoria, Illinois, 61615, United States
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Avon, Indiana, 46123, United States
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Evansville, Indiana, 47710, United States
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Evansville, Indiana, 47712, United States
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Indianapolis, Indiana, 46254, United States
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Waterloo, Iowa, 50702, United States
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Slidell, Louisiana, 70461, United States
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Sunset, Louisiana, 70584, United States
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Elkridge, Maryland, 21075, United States
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Chaska, Minnesota, 55318, United States
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Minneapolis, Minnesota, 55407-3799, United States
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City of Saint Peters, Missouri, 63376, United States
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Excelsior Springs, Missouri, 64024, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63128, United States
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Billings, Montana, 59102, United States
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Las Vegas, Nevada, 89016, United States
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Pahrump, Nevada, 89048, United States
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Hamilton, New Jersey, 08690, United States
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Albuquerque, New Mexico, 87102, United States
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East Syracuse, New York, 13057, United States
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Flushing, New York, 11355, United States
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Kingston, New York, 12401, United States
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Huntersville, North Carolina, 28078, United States
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Canal Fulton, Ohio, 44614, United States
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Canton, Ohio, 44718, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Kettering, Ohio, 45429, United States
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Mogadore, Ohio, 44260, United States
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Wandsworth, Ohio, 44281, United States
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Oregon City, Oregon, 97045, United States
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Beaver, Pennsylvania, 15009, United States
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Clairton, Pennsylvania, 15205, United States
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Coatsville, Pennsylvania, 19320, United States
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Erie, Pennsylvania, 16508, United States
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Sewickley, Pennsylvania, 15143, United States
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West Chester, Pennsylvania, 19382, United States
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Clinton, South Carolina, 29325, United States
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Columbia, South Carolina, 29201, United States
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Pelzer, South Carolina, 29669, United States
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Kingsport, Tennessee, 37660, United States
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Corpus Christi, Texas, 78404, United States
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Dallas, Texas, 75235, United States
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Georgetown, Texas, 78626, United States
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South Burlington, Vermont, 05403, United States
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Burke, Virginia, 22015, United States
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Manassas, Virginia, 20110, United States
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Salem, Virginia, 24153, United States
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Gig Harbor, Washington, 98335, United States
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Graham, Washington, 98338, United States
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Olympia, Washington, 98506, United States
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Tacoma, Washington, 98405, United States
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Vancouver, Washington, 98664, United States
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Wenatchee, Washington, 98801, United States
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Wauwatosa, Wisconsin, 53228, United States
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Buenos Aires, Buenos Aires, 1425, Argentina
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Buenos Aries, Buenos Aires, C1425AWC, Argentina
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Capital Federal, Buenos Aires, C1416DRJ, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, B1704ETD, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1155ADP, Argentina
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Córdoba, Córdoba Province, 5000, Argentina
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Mendoza, Mendoza Province, 5500, Argentina
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Buenos Aires, C1117ABH, Argentina
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Fortaleza, Ceará, 60120-021, Brazil
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Goiânia, Goiás, 74110-010, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-170, Brazil
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Campinas, São Paulo, 13073-350, Brazil
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São Paulo, São Paulo, 01323-001, Brazil
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Brasília, 71625-009, Brazil
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Coquitlam, British Columbia, V3K 3P4, Canada
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Bathurst, New Brunswick, E2A 4X7, Canada
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Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada
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St. John's, Newfoundland and Labrador, A1E 2C2, Canada
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Brampton, Ontario, L6T 3T1, Canada
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Smiths Falls, Ontario, K7A 4W8, Canada
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Toronto, Ontario, M9W 4L6, Canada
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Gatineau, Quebec, J8Y 6S8, Canada
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Sherbrooke, Quebec, J1H 4J6, Canada
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Tijuana, Baja California Norte, 22320, Mexico
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Durango, Durango, 34070, Mexico
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Pachuca, Hidalgo, 42039, Mexico
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Monterrey, Nuevo León, 64460, Mexico
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Karachi, 74800, Pakistan
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Lahore, 54000, Pakistan
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Cebu City, 6000, Philippines
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Manila, 1000, Philippines
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Manila, 1008, Philippines
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Marikina City, 1810, Philippines
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Quezon City, 1108, Philippines
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Gwangju, 501-757, South Korea
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Seoul, 110-749, South Korea
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Seoul, 139-872, South Korea
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Seoul, 152-703, South Korea
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Suwon, Kyonggi-do, 443-721, South Korea
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Uijeongbu-si, Kyonggi-do, 480-130, South Korea
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Changhua, 500, Taiwan
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Kaohsiung City, 833, Taiwan
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Taichung, 404, Taiwan
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Taipei, 114, Taiwan
GSK Investigational Site
Taoyuan Hsien, 333, Taiwan
Related Publications (1)
Borges JL, Bilezikian JP, Jones-Leone AR, Acusta AP, Ambery PD, Nino AJ, Grosse M, Fitzpatrick LA, Cobitz AR. A randomized, parallel group, double-blind, multicentre study comparing the efficacy and safety of Avandamet (rosiglitazone/metformin) and metformin on long-term glycaemic control and bone mineral density after 80 weeks of treatment in drug-naive type 2 diabetes mellitus patients. Diabetes Obes Metab. 2011 Nov;13(11):1036-46. doi: 10.1111/j.1463-1326.2011.01461.x.
PMID: 21682834BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Ten participants who started the study and were randomized did not receive any study medication (6 participants in the metformin arm and 4 participants in the avandamet arm). These participants are not included in any of the analysis populations.
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2006
First Posted
October 11, 2006
Study Start
October 1, 2006
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
November 23, 2016
Results First Posted
April 5, 2011
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.