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A Type 2 Diabetes Study of the Longer-Term Glycemic Effect of AVANDAMET vs. Metformin

NCT ID: NCT00386100

Last Updated: 2016-11-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

688 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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This was a phase IV, randomized, double-blind, global, multi-centre study. The study consisted of a 2 week screening period followed by an 80 week double-blind treatment period. Subjects who met all eligibility requirements were randomized in a 1:1 ratio, stratified by country, gender (male and female) and pre-screening HbA1c (≤9% or\>9) either to MET or AVM. When the substudy was added, a new randomization was created for the participating centers. Those subjects in the bone sub-study were stratified by country, gender (male, premenopausal female, and postmenopausal female), pre-screening HbA1c (i.e., ≤9%; \>9%), and either to MET or AVM.

At randomization, Visit 3 (Week 0), subjects were initiated at Dose Level 1. Treatment with AVM was initiated at a dose of 4 mg/500 mg and titrated up to a maximum total daily dose of AVM 8 mg/2000 mg. Treatment with MET therapy was initiated at a dose of 500 mg and titrated up to a maximum daily dose of 2000mg.

Conditions

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Diabetes Mellitus, Type 2

Keywords

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Fasting Plasma Glucose Dual energy X ray absorptiometry (DXA) Drug-naive Type 2 diabetes mellitus Bone Mineral Density Hyperglycemia HbA1c

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Metformin

MET 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.

Group Type PLACEBO_COMPARATOR

Metformin 500 mg (ttd)

Intervention Type DRUG

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.

Metformin 1000 mg (ttd)

Intervention Type DRUG

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.

Metformin 1500 mg (ttd)

Intervention Type DRUG

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.

Metformin 2000 mg (ttd)

Intervention Type DRUG

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.

Avandamet (Rosiglitazone maleate/metformin hydrochloride)

AVM 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

Group Type ACTIVE_COMPARATOR

Avandamet 6 mg/1500 mg (ttd)

Intervention Type DRUG

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

Avandamet 4 mg/1000 mg (ttd)

Intervention Type DRUG

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.

Avandamet 2 mg/500 mg (ttd)

Intervention Type DRUG

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.

Avandamet 8 mg/ 2000 mg (ttd)

Intervention Type DRUG

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.

Interventions

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Avandamet 6 mg/1500 mg (ttd)

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

Intervention Type DRUG

Avandamet 4 mg/1000 mg (ttd)

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.

Intervention Type DRUG

Avandamet 2 mg/500 mg (ttd)

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.

Intervention Type DRUG

Avandamet 8 mg/ 2000 mg (ttd)

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.

Intervention Type DRUG

Metformin 500 mg (ttd)

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.

Intervention Type DRUG

Metformin 1000 mg (ttd)

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.

Intervention Type DRUG

Metformin 1500 mg (ttd)

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.

Intervention Type DRUG

Metformin 2000 mg (ttd)

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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 a clinically significant abnormality which in the judgment of the investigator makes the subject unsuitable for inclusion in the study (e.g., physical examination, laboratory tests, or electrocardiogram, etc).
* 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.
* The subject is not willing to comply with visits and procedures described in the protocol.
* The subject has a disease that may affect bone turnover including, but not limited to: Paget's disease, hypercalcemia, hypocalcemia, hyperparathyroidism, hyperthyroidism, osteomalacia, metastatic bone disease
* The subject has a weight of greater than 300 lbs (136.4 kg).
* The subject has received treatment with bisphosphonates (≥1 month cumulative treatment within the last 12 months) or fluoride (dose greater than 10mg/day within the previous 5 years).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Tuscaloosa, Alabama, United States

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Gilbert, Arizona, United States

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Alhambra, California, United States

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Artesia, California, United States

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Greenbrae, California, United States

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Roseville, California, United States

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Sacramento, California, United States

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Wheat Ridge, Colorado, United States

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Hialeah, Florida, United States

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Ocala, Florida, United States

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Kahului, Hawaii, United States

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Peoria, Illinois, United States

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Avon, Indiana, United States

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Evansville, Indiana, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Waterloo, Iowa, United States

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Slidell, Louisiana, United States

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Sunset, Louisiana, United States

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Elkridge, Maryland, United States

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Chaska, Minnesota, United States

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Minneapolis, Minnesota, United States

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City of Saint Peters, Missouri, United States

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Excelsior Springs, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Las Vegas, Nevada, United States

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Pahrump, Nevada, United States

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Hamilton, New Jersey, United States

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Albuquerque, New Mexico, United States

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East Syracuse, New York, United States

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Flushing, New York, United States

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Kingston, New York, United States

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Huntersville, North Carolina, United States

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Canal Fulton, Ohio, United States

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Canton, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Kettering, Ohio, United States

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Mogadore, Ohio, United States

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Wandsworth, Ohio, United States

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Oregon City, Oregon, United States

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Beaver, Pennsylvania, United States

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Clairton, Pennsylvania, United States

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Coatsville, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Sewickley, Pennsylvania, United States

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West Chester, Pennsylvania, United States

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Clinton, South Carolina, United States

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Columbia, South Carolina, United States

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Pelzer, South Carolina, United States

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Kingsport, Tennessee, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Georgetown, Texas, United States

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South Burlington, Vermont, United States

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Burke, Virginia, United States

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Manassas, Virginia, United States

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Salem, Virginia, United States

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Gig Harbor, Washington, United States

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Graham, Washington, United States

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Olympia, Washington, United States

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Tacoma, Washington, United States

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Vancouver, Washington, United States

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Wenatchee, Washington, United States

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Wauwatosa, Wisconsin, United States

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Buenos Aires, Buenos Aires, Argentina

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Buenos Aries, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Mendoza, Mendoza Province, Argentina

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Buenos Aires, , Argentina

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Fortaleza, Ceará, Brazil

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Goiânia, Goiás, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Campinas, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Brasília, , Brazil

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Coquitlam, British Columbia, Canada

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Bathurst, New Brunswick, Canada

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Bay Roberts, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Brampton, Ontario, Canada

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Smiths Falls, Ontario, Canada

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Toronto, Ontario, Canada

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Gatineau, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Tijuana, Baja California Norte, Mexico

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Durango, Durango, Mexico

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Pachuca, Hidalgo, Mexico

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Monterrey, Nuevo León, Mexico

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Karachi, , Pakistan

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Lahore, , Pakistan

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Cebu City, , Philippines

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Manila, , Philippines

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Manila, , Philippines

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Marikina City, , Philippines

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Quezon City, , Philippines

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Gwangju, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Suwon, Kyonggi-do, , South Korea

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Uijeongbu-si, Kyonggi-do, , South Korea

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Changhua, , Taiwan

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Taoyuan Hsien, , Taiwan

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Countries

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United States Argentina Brazil Canada Mexico Pakistan Philippines South Korea Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 21682834 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Dataset Specification

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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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

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AVT105913

Identifier Type: -

Identifier Source: org_study_id