Diabetes Mellitus, Type 2Phase 3NCT00499707
Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects
A Phase 3 study testing rosiglitazone maleate/metformin hydrochloride in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 102 sites in 7 countries.
Trial summary
The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin will safely and effectively control glycemia as first line oral therapy in subjects type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- rosiglitazone maleate/metformin hydrochloride
- How many people
- 453 participants
- Where
- 102 sitesin 7 countries
- Study dates
- 8 Oct 2003to 16 Dec 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years of age
- Clinical diagnosis of type 2 diabetes
- HbA1c >7.5% to 11%
- FPG <270mg/dL (15mmol)
- Current treatment with diet and/or exercise alone, or no more than 15 days of an anti-diabetic medication or insulin within 12 weeks of screening
Who cannot join
- Clinically significant renal or hepatic disease
- Presence of anemia
- Presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring therapy
- Systolic blood pressure >170mmHg or diastolic blood pressure >100mmHg, while on anti-hypertensive treatment
- Chronic disease requiring intermittent or chronic treatment with corticosteroids
- Any female lactating, pregnant, or planning to become pregnant
Show all 9Show fewer
- History of hepatocellular reaction, severe edema or a medically serious fluid related event associated with any thiazolidinedione
- Presence of acute or chronic metabolic acidosis
- History of diabetic ketoacidosis
Trial locations and contacts
102 sites in 7 countries.
102 sites in 7 countries
United States48 sites
GSK Investigational Site
Anniston, Alabama, 36207
GSK Investigational Site
Arlington, Texas, 76017
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Beaumont, Texas, 77701
GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Bryan, Texas, 77802
GSK Investigational Site
Chandler, Arizona, 85224
GSK Investigational Site
Charlotte, North Carolina, 28210
GSK Investigational Site
Chesterfield, Missouri, 63017
GSK Investigational Site
Chicago, Illinois, 60607
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Downingtown, Pennsylvania, 19335
GSK Investigational Site
Encinitas, California, 92024
GSK Investigational Site
Evansville, Indiana, 47713
GSK Investigational Site
Fayetteville, Georgia, 30214
GSK Investigational Site
Fullerton, California, 92835
GSK Investigational Site
Jackson, Mississippi, 39202
GSK Investigational Site
Jacksonville, Florida, 32204
GSK Investigational Site
Johnson City, Tennessee, 37601
GSK Investigational Site
Kansas City, Missouri, 64111
GSK Investigational Site
Kingston, New York, 12401
GSK Investigational Site
Las Vegas, Nevada, 89103
GSK Investigational Site
Los Banos, California, 93635
GSK Investigational Site
Melbourne, Florida, 32901
GSK Investigational Site
Miami, Florida, 33156
GSK Investigational Site
Midland, Texas, 79705
GSK Investigational Site
Mission Viejo, California, 92691
GSK Investigational Site
Mogadore, Ohio, 44260
GSK Investigational Site
New York, New York, 10024
GSK Investigational Site
New York, New York, 10029
GSK Investigational Site
New York, New York, 10032
GSK Investigational Site
Newburgh, Indiana, 47630
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
Phoenix, Arizona, 85014
GSK Investigational Site
Phoenix, Arizona, 85050
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
Saint Cloud, Florida, 34769
GSK Investigational Site
San Antonio, Texas, 78221
GSK Investigational Site
San Antonio, Texas, 78237
GSK Investigational Site
Seattle, Washington, 98108
GSK Investigational Site
Slidell, Louisiana, 70461
GSK Investigational Site
Spokane, Washington, 99207
GSK Investigational Site
St Louis, Missouri, 63376
GSK Investigational Site
Tucson, Arizona, 85745
GSK Investigational Site
Warminster, Pennsylvania, 18974
GSK Investigational Site
Wenatchee, Washington, 98801
GSK Investigational Site
West Chester, Pennsylvania, 19382
GSK Investigational Site
Woodstock, Georgia, 30189
Canada29 sites
GSK Investigational Site
Brampton, Ontario, L6T 3T1
GSK Investigational Site
Burlington, Ontario, L7M 4Y1
GSK Investigational Site
Calgary, Alberta, T3E 0C5
GSK Investigational Site
Coquitlam, British Columbia, V3K 3V9
GSK Investigational Site
Courtice, Ontario, L1E 3C3
GSK Investigational Site
Halifax, Nova Scotia, B3K 5R3
GSK Investigational Site
Kitchener, Ontario, N2C 2N9
GSK Investigational Site
Langley, British Columbia, V3A 4H9
GSK Investigational Site
Laval, Quebec, H7T 2P5
GSK Investigational Site
Moncton, New Brunswick, E1G 1A7
GSK Investigational Site
Montreal, Quebec, H1V 1X4
GSK Investigational Site
Montreal, Quebec, H3S 2W1
GSK Investigational Site
Montreal, Quebec, H4N 2W2
GSK Investigational Site
North Bay, Ontario, P1B 2H3
GSK Investigational Site
Oshawa, Ontario, L1H 1C2
GSK Investigational Site
Peterborough, Ontario, K9H 5G1
GSK Investigational Site
Peterborough, Ontario, K9J 7B3
GSK Investigational Site
Plessisville, Quebec, G6L 3J1
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3
GSK Investigational Site
Regina, Saskatchewan, S4S 0A2
GSK Investigational Site
Regina, Saskatchewan, S4S 3R8
GSK Investigational Site
Renfrew, Ontario, K7V 1P6
GSK Investigational Site
Saint Insidore de Dorchester, Quebec, G0S 2S0
GSK Investigational Site
Saint-Marc-des-Carrieres, Quebec, G0A 4B0
GSK Investigational Site
Sainte Jerome, Quebec, J7Z 5T3
GSK Investigational Site
Saskatoon, Saskatchewan, S7K 0M5
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1
GSK Investigational Site
Stoney Creek, Ontario, L8G 2V6
GSK Investigational Site
Toronto, Ontario, M3J 1N2
Australia9 sites
GSK Investigational Site
Camperdown, New South Wales, 2050
GSK Investigational Site
Caulfield, Victoria, 3162
GSK Investigational Site
Fremantle, Western Australia, 6959
GSK Investigational Site
Kippa-Ring, Queensland, 4021
GSK Investigational Site
North Adelaide, South Australia, 5006
GSK Investigational Site
Perth, Western Australia, 6000
GSK Investigational Site
St Leonards, New South Wales, 2065
GSK Investigational Site
Wollongong, New South Wales, 2500
GSK Investigational Site
Woolloongabba, Queensland, 4102
Mexico6 sites
GSK Investigational Site
Durango, 3400
GSK Investigational Site
Guadalajara, Jalisco, 44340
GSK Investigational Site
Mexico City, 11850
GSK Investigational Site
Mexico City, 14050
GSK Investigational Site
Monterrey, Nuevo León, 64570
GSK Investigational Site
Tijuana, Baja California Norte, 22320
New Zealand5 sites
GSK Investigational Site
Auckland, 1311
GSK Investigational Site
Auckland, 1701
GSK Investigational Site
Christchurch, 8001
GSK Investigational Site
Rotorua, 3201
GSK Investigational Site
Wellington, 6035
South Korea3 sites
GSK Investigational Site
Pusan, 602-739
GSK Investigational Site
Seoul, 139-872
GSK Investigational Site
Uijeongbu-si, 480-821
Brazil2 sites
GSK Investigational Site
Recife, Pernambuco, 50100-130
GSK Investigational Site
São Paulo, 04020-041
About this study
Official title: A Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Fixed Dose Rosiglitazone/Metformin Combination Therapy Compared to Both Rosiglitazone and Metformin Monotherapies in Drug Naive Type 2 Diabetes Mellitus Subjects
The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin will safely and effectively control glycemia as first line oral therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- rosiglitazone maleate/metformin hydrochloride
- Keywords
- HbA1c, Drug-naive, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazone maleate/metformin hydrochlorideDrug
rosiglitazone maleate/metformin hydrochloride
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hemoglobin A1c (HbA1c) at week 32.
Measured: at 32 week
Secondary outcomes (1)
Key Secondary Measures: Change in FPG HbA1c and FPG responders Change in insulin, C-peptide, free fatty acids, lipids, insulin sensitivity and beta cell function Adverse Events Vital Signs Weight 32 weeks
Measured: at 32 weeksInvalid value
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study start8 Oct 2003
- Primary completion1 Dec 2004
- Study completion16 Dec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499707
- Sponsor's protocol ID
- 712753/007
- Status last verified
- Mar 2018
- First submitted
- 9 Jul 2007
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Chou H., et. al.; Rosiglitazone and metformin fixed-dose combination provides superior glycaemic control compared to metformin and rosiglitazone monotherapies, and was well tolerated in drug-naïve patients with T2DM [poster]; European Association for the Study of Diabetes, 10-15 September 2005, Athens, Greece.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Fixed Dose Rosiglitazone/Metformin Combination Therapy Compared to Both Rosiglitazone and Metformin Monotherapies in Drug Naive Type 2 Diabetes Mellitus Subjects
- ClinicalTrials.gov ID
- NCT00499707
- Acronym / sponsor ID
- 712753/007
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- HbA1c, Drug-naive, type 2 diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2003
- Primary completion
- 1 Dec 2004 (actual)
- Study completion
- 16 Dec 2004 (actual)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin will safely and effectively control glycemia as first line oral therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 70 years of age
- Clinical diagnosis of type 2 diabetes
- HbA1c >7.5% to 11%
- FPG <270mg/dL (15mmol)
- Current treatment with diet and/or exercise alone, or no more than 15 days of an anti-diabetic medication or insulin within 12 weeks of screening
Key exclusion criteria (9 listed)
- Clinically significant renal or hepatic disease
- Presence of anemia
- Presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring therapy
- Systolic blood pressure >170mmHg or diastolic blood pressure >100mmHg, while on anti-hypertensive treatment
- Chronic disease requiring intermittent or chronic treatment with corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosiglitazone maleate/metformin hydrochloriderosiglitazone maleate/metformin hydrochloride | Drug | – |
Primary outcome
Change from baseline in hemoglobin A1c (HbA1c) at week 32.
Time frame: at 32 week
1 secondary outcome
Key Secondary Measures: Change in FPG HbA1c and FPG responders Change in insulin, C-peptide, free fatty acids, lipids, insulin sensitivity and beta cell function Adverse Events Vital Signs Weight 32 weeks
Time frame: at 32 weeksInvalid value
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Results publicationChou H., et. al.; Rosiglitazone and metformin fixed-dose combination provides superior glycaemic control compared to metformin and rosiglitazone monotherapies, and was well tolerated in drug-naïve patients with T2DM [poster]; European Association for the Study of Diabetes, 10-15 September 2005, Athens, Greece.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
102 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rosiglitazone maleate/metformin hydrochloride in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 102 sites in 7 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 5 inclusion and 9 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 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 102 sites in United States, Canada, Australia, Mexico, New Zealand and 2 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 hemoglobin A1c (HbA1c) at week 32. (time frame: at 32 week). 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 NCT00499707, 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 21 Mar 2018.