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Diabetes Mellitus, Type 2Phase 4NCT00386100

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

A Phase 4 study testing Avandamet 6 mg/1500 mg (ttd), Avandamet 4 mg/1000 mg (ttd) and Avandamet 2 mg/500 mg (ttd) in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 116 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Avandamet 6 mg/1500 mg (ttd), Avandamet 4 mg/1000 mg (ttd) and Avandamet 2 mg/500 mg (ttd)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
688 participants
Where
116 sitesin 9 countries
Study dates
Oct 2006to Sep 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
Show all 20Show fewer
  • 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).

Trial locations and contacts

116 sites in 9 countries.

116 sites in 9 countries

United States71 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87102

  • GSK Investigational Site

    Alhambra, California, 91801

  • GSK Investigational Site

    Artesia, California, 90701

  • GSK Investigational Site

    Avon, Indiana, 46123

  • GSK Investigational Site

    Beaver, Pennsylvania, 15009

  • GSK Investigational Site

    Billings, Montana, 59102

  • GSK Investigational Site

    Burke, Virginia, 22015

  • GSK Investigational Site

    Canal Fulton, Ohio, 44614

  • GSK Investigational Site

    Canton, Ohio, 44718

  • GSK Investigational Site

    Chaska, Minnesota, 55318

  • GSK Investigational Site

    City of Saint Peters, Missouri, 63376

  • GSK Investigational Site

    Clairton, Pennsylvania, 15205

  • GSK Investigational Site

    Cleveland, Ohio, 44195

  • GSK Investigational Site

    Clinton, South Carolina, 29325

  • GSK Investigational Site

    Coatsville, Pennsylvania, 19320

  • GSK Investigational Site

    Columbia, South Carolina, 29201

  • GSK Investigational Site

    Columbus, Ohio, 43210

  • GSK Investigational Site

    Corpus Christi, Texas, 78404

  • GSK Investigational Site

    Dallas, Texas, 75235

  • GSK Investigational Site

    East Syracuse, New York, 13057

  • GSK Investigational Site

    Elkridge, Maryland, 21075

  • GSK Investigational Site

    Erie, Pennsylvania, 16508

  • GSK Investigational Site

    Evansville, Indiana, 47710

  • GSK Investigational Site

    Evansville, Indiana, 47712

  • GSK Investigational Site

    Excelsior Springs, Missouri, 64024

  • GSK Investigational Site

    Flushing, New York, 11355

  • GSK Investigational Site

    Georgetown, Texas, 78626

  • GSK Investigational Site

    Gig Harbor, Washington, 98335

  • GSK Investigational Site

    Gilbert, Arizona, 85296

  • GSK Investigational Site

    Glendale, Arizona, 85308

  • GSK Investigational Site

    Graham, Washington, 98338

  • GSK Investigational Site

    Greenbrae, California, 94904

  • GSK Investigational Site

    Hamilton, New Jersey, 08690

  • GSK Investigational Site

    Hialeah, Florida, 33013

  • GSK Investigational Site

    Huntersville, North Carolina, 28078

  • GSK Investigational Site

    Indianapolis, Indiana, 46254

  • GSK Investigational Site

    Kahului, Hawaii, 96732

  • GSK Investigational Site

    Kettering, Ohio, 45429

  • GSK Investigational Site

    Kingsport, Tennessee, 37660

  • GSK Investigational Site

    Kingston, New York, 12401

  • GSK Investigational Site

    Las Vegas, Nevada, 89016

  • GSK Investigational Site

    Manassas, Virginia, 20110

  • GSK Investigational Site

    Minneapolis, Minnesota, 55407-3799

  • GSK Investigational Site

    Mogadore, Ohio, 44260

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Olympia, Washington, 98506

  • GSK Investigational Site

    Oregon City, Oregon, 97045

  • GSK Investigational Site

    Pahrump, Nevada, 89048

  • GSK Investigational Site

    Pelzer, South Carolina, 29669

  • GSK Investigational Site

    Peoria, Illinois, 61615

  • GSK Investigational Site

    Phoenix, Arizona, 85020

  • GSK Investigational Site

    Roseville, California, 95661

  • GSK Investigational Site

    Sacramento, California, 95825

  • GSK Investigational Site

    Salem, Virginia, 24153

  • GSK Investigational Site

    Sewickley, Pennsylvania, 15143

  • GSK Investigational Site

    Slidell, Louisiana, 70461

  • GSK Investigational Site

    South Burlington, Vermont, 05403

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    St Louis, Missouri, 63128

  • GSK Investigational Site

    Sunset, Louisiana, 70584

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tucson, Arizona, 85712

  • GSK Investigational Site

    Tucson, Arizona, 85745

  • GSK Investigational Site

    Tuscaloosa, Alabama, 35406

  • GSK Investigational Site

    Vancouver, Washington, 98664

  • GSK Investigational Site

    Wandsworth, Ohio, 44281

  • GSK Investigational Site

    Waterloo, Iowa, 50702

  • GSK Investigational Site

    Wauwatosa, Wisconsin, 53228

  • GSK Investigational Site

    Wenatchee, Washington, 98801

  • GSK Investigational Site

    West Chester, Pennsylvania, 19382

  • GSK Investigational Site

    Wheat Ridge, Colorado, 80033

Other trials in United States

Canada9 sites

  • GSK Investigational Site

    Bathurst, New Brunswick, E2A 4X7

  • GSK Investigational Site

    Bay Roberts, Newfoundland and Labrador, A0A 1G0

  • GSK Investigational Site

    Brampton, Ontario, L6T 3T1

  • GSK Investigational Site

    Coquitlam, British Columbia, V3K 3P4

  • GSK Investigational Site

    Gatineau, Quebec, J8Y 6S8

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 4J6

  • GSK Investigational Site

    Smiths Falls, Ontario, K7A 4W8

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1E 2C2

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

Other trials in Canada

Argentina8 sites

  • GSK Investigational Site

    Buenos Aires, Buenos Aires, 1425

  • GSK Investigational Site

    Buenos Aires, C1117ABH

  • GSK Investigational Site

    Buenos Aries, Buenos Aires, C1425AWC

  • GSK Investigational Site

    Capital Federal, Buenos Aires, C1416DRJ

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, B1704ETD

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1155ADP

  • GSK Investigational Site

    Córdoba, Córdoba Province, 5000

  • GSK Investigational Site

    Mendoza, Mendoza Province, 5500

Other trials in Argentina

Brazil6 sites

  • GSK Investigational Site

    Brasília, 71625-009

  • GSK Investigational Site

    Campinas, São Paulo, 13073-350

  • GSK Investigational Site

    Fortaleza, Ceará, 60120-021

  • GSK Investigational Site

    Goiânia, Goiás, 74110-010

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035-170

  • GSK Investigational Site

    São Paulo, São Paulo, 01323-001

Other trials in Brazil

South Korea6 sites

  • GSK Investigational Site

    Gwangju, 501-757

  • GSK Investigational Site

    Seoul, 110-749

  • GSK Investigational Site

    Seoul, 139-872

  • GSK Investigational Site

    Seoul, 152-703

  • GSK Investigational Site

    Suwon, Kyonggi-do, 443-721

  • GSK Investigational Site

    Uijeongbu-si, Kyonggi-do, 480-130

Other trials in South Korea

Philippines5 sites

  • GSK Investigational Site

    Cebu City, 6000

  • GSK Investigational Site

    Manila, 1000

  • GSK Investigational Site

    Manila, 1008

  • GSK Investigational Site

    Marikina City, 1810

  • GSK Investigational Site

    Quezon City, 1108

Other trials in Philippines

Taiwan5 sites

  • GSK Investigational Site

    Changhua, 500

  • GSK Investigational Site

    Kaohsiung City, 833

  • GSK Investigational Site

    Taichung, 404

  • GSK Investigational Site

    Taipei, 114

  • GSK Investigational Site

    Taoyuan Hsien, 333

Other trials in Taiwan

Mexico4 sites

  • GSK Investigational Site

    Durango, Durango, 34070

  • GSK Investigational Site

    Monterrey, Nuevo León, 64460

  • GSK Investigational Site

    Pachuca, Hidalgo, 42039

  • GSK Investigational Site

    Tijuana, Baja California Norte, 22320

Other trials in Mexico

Pakistan2 sites

  • GSK Investigational Site

    Karachi, 74800

  • GSK Investigational Site

    Lahore, 54000

Other trials in Pakistan

About this study

Official title: A Randomized, Parallel Group, Double-blind, Multi-center Study Comparing the Efficacy and Safety of AVANDAMET and Metformin After 80 Weeks of Treatment.

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.

Read the detailed description

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.

Being tested
Avandamet 6 mg/1500 mg (ttd), Avandamet 4 mg/1000 mg (ttd), Avandamet 2 mg/500 mg (ttd), Avandamet 8 mg/ 2000 mg (ttd), Metformin 500 mg (ttd)
Keywords
Fasting Plasma Glucose, Dual energy X ray absorptiometry (DXA), Drug-naive, Type 2 diabetes mellitus, Bone Mineral Density, Hyperglycemia, HbA1c
Medical subject headings
Diabetes Mellitus, Type 2, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avandamet 6 mg/1500 mg (ttd)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)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)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)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.

  • Metformin 500 mg (ttd)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)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)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)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.

Study groups in NCT00386100
Study groupRoleWhat they receive
MetforminPlacebo 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.
Receives: Drug: Metformin 500 mg (ttd); Drug: Metformin 1000 mg (ttd); Drug: Metformin 1500 mg (ttd); Drug: Metformin 2000 mg (ttd)
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
Receives: Drug: Avandamet 6 mg/1500 mg (ttd); Drug: Avandamet 4 mg/1000 mg (ttd); Drug: Avandamet 2 mg/500 mg (ttd); Drug: Avandamet 8 mg/ 2000 mg (ttd)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 80

Secondary outcomes (28)

  1. Mean Change From Baseline in HbA1c at Week 80

    Blood was taken for serum Hb1AC measurements. Change from baseline was calculated as the Week 80 value minus the baseline value, with LOCF from Week 32 for withdrawn participants or missing values.

    Measured: Baseline and Week 80

  2. Number of Participants Achieving HbA1c <=6.5% and <7% at Week 80

    Blood was taken for serum Hb1AC measurements. Hb1AC responders were described as participants having achieved Hb1AC <=6% and <7% at Week 80 with LOCF from Week 32.

    Measured: Week 80

  3. Change in Fasting Plasma Glucose (FPG) From Baseline at Week 80

    Blood was taken for serum FPG measurements. Change from baseline was calculated as the Week 80 value minus the baseline value.

    Measured: Baseline and Week 80

  4. Change From Baseline in FPG at Week 80

    Blood was taken for serum FPG measurements. Change from baseline was calculated as the Week 80 value minus the baseline value with LOCF from Week 32 for withdrawn participants or missing values.

    Measured: Baseline and Week 80

  5. Number of Participants Achieving FPG <=6 mmol/L (110 mg/dL) and <=7 mmol/L (126 mg/dL) at Week 80

    Blood was taken for serum FPG measurements. FPG responders were described as participants having achieved FPG <=6 mmol/L (110 mg/dL) and <7 mmol/L (126 mg/dL) Hb1AC at Week 80 with LOCF from Week 32.

    Measured: Week 80

  6. Number of Participants Achieving Treatment Failure

    Treatment failure was defined as an HbA1c level >= 7% after Week 32 or withdrawal due to insufficient therapeutic effect (ITE) at any time.

    Measured: Randomization to treatment failure (up to Week 80)

  7. Percent Change From Baseline in Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Triglycerides at Week 80

    Blood was taken for measurement of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Percent change from baseline at Week 80 was based on log transformed data. Geometric mean, GM; standard error, SE. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.

    Measured: Baseline and Week 80

  8. Percent Change From Baseline in Adiponectin at Week 80 (United States [US] and Mexico Subset of Participants )

    Blood was taken for measurement of adiponectin. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only.

    Measured: Baseline and Week 80

  9. Percent Change From Baseline in C-reactive Protein (CRP) at Week 80 (US and Mexico Subset of Participants)

    Blood was taken for measurement of CRP. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only.

    Measured: Baseline and Week 80

  10. Percent Change in Free Fatty Acids (FFA) From Baseline at Week 80 (US and Mexico Subset of Participants).

    Blood was taken for measurement of FFA. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only.

    Measured: Baseline and Week 80

  11. Change in Fasting Insulin From Baseline at Week 80 (US and Mexico Subset of Participants)

    Blood was taken for fasting insulin measurements. Change from baseline was calculated as the Week 80 value minus the baseline value, with LOCF from Week 32 for withdrawn participants or missing values. This outcome measure was analyzed for a subset of participants in the US and Mexico only.

    Measured: Baseline and Week 80

  12. Change in C-peptide From Baseline at Week 80 (US and Mexico Subset of Participants)

    Blood was taken for C-peptide measurements. Change from baseline was calculated as the Week 80 value minus the baseline value with LOCF from Week 32 for withdrawn participants or missing values. This outcome measure was analyzed for a subset of participants in the US and Mexico only.

    Measured: Baseline and Week 80

  13. Percent Change From Baseline in in HOMA-S and HOMA-B to Week 80 (US and Mexico Subset of Participants)

    Blood was taken for measurement of homeostasis model assessment for insulin sensitivity (HOMA-S) and beta-cell function (HOMA-B). Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only. GM, geometric mean; SE, standard error.

    Measured: Baseline and Week 80

  14. Slope of Delta-cell Function as Estimated by the Ratio deltaI/deltaG

    The ratio Delta I/Delta G is calculated based on the oral glucose tolerance test (OGTT), where Delta I = (30 minute immunoreactive insulin minus 0 minute immunoreactive insulin) and Delta G = (30 minute plasma glucose minus 0 minute plasma glucose). The 0 minute values are fasting insulin and glucose; the 30 minute values are taken 30 minutes after the oral glucose challenge. This outcome measure was analyzed for a subset of participants in the US and Mexico only.

    Measured: Baseline and Week 80

  15. Number of Participants at Final Dose Level

    Measured: Baseline to Week 80 or withdrawal

  16. Percent Change From Baseline in Lumbar Spine Bone Mass Density (BMD) at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)

    BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100%. This outcome measure was analyzed for a subset of participants in the bone study only.

    Measured: Baseline and Weeks 20, 56, and 80

  17. Percent Change From Baseline in Total Hip BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)

    BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.

    Measured: Baseline and Weeks 20, 56, and 80

  18. Percent Change From Baseline in Trochanter BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)

    BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.

    Measured: Baseline and Weeks 20, 56, and 80

  19. Percent Change From Baseline in Femoral Neck BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)

    BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.

    Measured: Baseline and Weeks 20, 56, and 80

  20. Percent Change From Baseline in Distal Radius BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)

    BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.

    Measured: Baseline and Weeks 20, 56, and 80

  21. Percent Change From Baseline in Total Body BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)

    BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.

    Measured: Baseline and Weeks 20, 56, and 80

  22. Percent Change From Baseline in Serum Calcium at Weeks 12, 32, 56, and 80

    Blood was taken for measurement of serum calcium. Percent change from baseline was based on log transformed data. Geometric mean, GM; standard error, SE. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.

    Measured: Baseline and Weeks 12, 32, 56, and 80

  23. Percent Change From Baseline in Intact Parathyroid Hormone at Week 80

    Blood was taken for measurement of intact parathyroid hormone. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.

    Measured: Baseline and Week 80

  24. Percent Change From Baseline in 25-hydroxy Vitamin D at Week 80

    Blood was taken for measurement of 25-hydroxy vitamin D. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.

    Measured: Baseline and Week 80

  25. Percent Change From Baseline in Estradiol at Weeks 20, 56, and 80

    Blood was taken for measurement of estradiol. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of female participants in the bone study only. n is the number of evaluable participants, which is the number of female participants with a value at baseline and at the specified visit for the parameter of interest.

    Measured: Baseline and Weeks 20, 56, and 80

  26. Percent Change From Baseline in C-terminal Telopeptide (CTX) at Weeks 20, 56, and 80

    Blood was taken for measurement of CTX. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.

    Measured: Baseline and Weeks 20, 56, and 80

  27. Percent Change From Baseline in Procollagen Type-1 N-propeptide (P1NP) at Weeks 20, 56, and 80

    Blood was taken for measurement of P1NP. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.

    Measured: Baseline and Weeks 20, 56, and 80

  28. Percent Change From Baseline in Bone Alkaline Phosphatase (BSAP) at Weeks 20, 56, and 80

    Blood was taken for measurement of BSAP. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.

    Measured: Baseline and Weeks 20, 56, and 80

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionSep 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
688 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00386100
Sponsor's protocol ID
AVT105913
Status last verified
Oct 2016
First submitted
9 Oct 2006
Last updated
23 Nov 2016
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 21682834

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Avandamet 6 mg/1500 mg (ttd), Avandamet 4 mg/1000 mg (ttd) and Avandamet 2 mg/500 mg (ttd) in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 116 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, Canada, Argentina, Brazil, South Korea and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c at Week 80 (time frame: Baseline and Week 80). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00386100, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2016.

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