Diabetes Mellitus, Type 2Phase 3NCT00067951
A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics
A Phase 3 study testing rosiglitazone/metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 94 sites in 5 countries.
Trial summary
The purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. 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/metformin
- How many people
- 190 participants
- Where
- 94 sitesin 5 countries
- Study dates
- 17 Oct 2003to 30 Nov 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
- Laboratory result for HbA1c >11% or FPG >270mg/dL
- Clinical diagnosis of Type II diabetes
- Prior treatment with diet and/or exercise alone, or less than 15 days of prior treatment with an oral anti-diabetic medication or insulin.
Who cannot join
- Women who are pregnant
Trial locations and contacts
94 sites in 5 countries.
94 sites in 5 countries
United States49 sites
GSK Investigational Site
Anniston, Alabama, 36207
GSK Investigational Site
Arlington, Texas, 76017
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Beaumont, Texas, 77701
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
Corpus Christi, Texas, 78411
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
Canada28 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, S4P 3X1
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
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
About this study
Official title: An Open-label Trial to Evaluate the Safety and Efficacy of Fixed Dose Rosiglitazone/Metformin Combination Therapy in Poorly-controlled Subjects With Type 2 Diabetes Mellitus
The purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood after an 8 hour fast.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- rosiglitazone/metformin
- Keywords
- Hyperglycemia, HbA1c, Hemoglobin A1c, Type 2 diabetes mellitus
- 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.
rosiglitazone/metforminDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment.
Secondary outcomes (1)
Change in FPG, insulin,C-peptide, insulin sensitivity,beta cell function, free fatty acids, lipids. Change in weight, vital signs, clinical laboratory tests, and adverse experiences.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2003 (estimated)
- Study start17 Oct 2003
- Primary completion1 Nov 2004
- Study completion30 Nov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 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
- NCT00067951
- Sponsor's protocol ID
- 712753/004
- Status last verified
- Mar 2018
- First submitted
- 3 Sep 2003
- Last updated
- 21 Mar 2018
- Results posted
- No
- 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.
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
- An Open-label Trial to Evaluate the Safety and Efficacy of Fixed Dose Rosiglitazone/Metformin Combination Therapy in Poorly-controlled Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00067951
- Acronym / sponsor ID
- 712753/004
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Hyperglycemia, HbA1c, Hemoglobin A1c, Type 2 diabetes mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2003
- Primary completion
- 1 Nov 2004 (actual)
- Study completion
- 30 Nov 2004 (actual)
- First posted
- 5 Sep 2003 (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 research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood after an 8 hour fast.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Laboratory result for HbA1c >11% or FPG >270mg/dL
- Clinical diagnosis of Type II diabetes
- Prior treatment with diet and/or exercise alone, or less than 15 days of prior treatment with an oral anti-diabetic medication or insulin.
Key exclusion criteria (1 listed)
- Women who are pregnant
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/metformin | Drug | – |
Primary outcome
Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment.
1 secondary outcome
Change in FPG, insulin,C-peptide, insulin sensitivity,beta cell function, free fatty acids, lipids. Change in weight, vital signs, clinical laboratory tests, and adverse experiences.
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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
94 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rosiglitazone/metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 94 sites in 5 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 3 inclusion and 1 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 94 sites in United States, Canada, Australia, New Zealand, South Korea. 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?
Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.