Diabetes Mellitus, Type 2Phase 4NCT00241605
AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus
A Phase 4 study testing rosiglitazone/metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 91 sites in Canada.
Trial summary
This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus. 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?
- rosiglitazone/metformin
- How many people
- 600 participants
- Where
- 91 sitesCanada
- Study dates
- 25 Jun 2003to 16 Dec 2005
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 75 years of age with Type 2 Diabetes Mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).
- Patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.
- Women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.
Who cannot join
- Prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
- Have a known hypersensitivity to thiazolidinediones or biguanides.
- Currently using insulin or any oral anti-diabetic agent other than metformin.
- History of metabolic acidosis.
- History of substance abuse.
- Have active cancer other than localized squamous or basal cell carcinoma.
- Chronic disease requiring treatment with corticosteroids.
- Other criteria will be evaluated at the screening visit.
Trial locations and contacts
91 sites in 1 country.
91 sites in 1 country
Canada91 sites
GSK Investigational Site
Ajax, Ontario, L1S 6N2
GSK Investigational Site
Aldergrove, British Columbia, V4W 3L6
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0
GSK Investigational Site
Brampton, Ontario, L6T 3T1
GSK Investigational Site
Brampton, Ontario, L6T 4S5
GSK Investigational Site
Brossard, Quebec, J4Z 2K9
GSK Investigational Site
Burlington, Ontario, L7M 4Y1
GSK Investigational Site
Calgary, Alberta, T1Y 3R6
GSK Investigational Site
Calgary, Alberta, T1Y 6J2
GSK Investigational Site
Calgary, Alberta, T2A 0P9
GSK Investigational Site
Calgary, Alberta, T2L 2V9
GSK Investigational Site
Calgary, Alberta, T3B 0M3
GSK Investigational Site
Calgary, Alberta, T3E 0C5
GSK Investigational Site
Calgary, Alberta, T3E 7C4
GSK Investigational Site
Cambridge, Ontario, N3C 1Z3
GSK Investigational Site
Carbonear, Newfoundland and Labrador, A1Y 1C4
GSK Investigational Site
Charlesbourg, Quebec, G1G 4A2
GSK Investigational Site
Charlesbourg, Quebec, G1H 6P2
GSK Investigational Site
Châteauguay, Quebec, J6K 3A9
GSK Investigational Site
Courcelette, Quebec, G0A 1R1
GSK Investigational Site
Cowansville, Quebec, J2K 2X9
GSK Investigational Site
Dartmouth, Nova Scotia, B2W 2S8
GSK Investigational Site
Edmonton, Alberta, T5A 4L8
GSK Investigational Site
Edmonton, Alberta, T6L 6K3
GSK Investigational Site
Fort Erie, Ontario, L2A 1Z3
GSK Investigational Site
Fredericton, New Brunswick, E5L 1S1
GSK Investigational Site
Halifax, Nova Scotia, B3M 3W8
GSK Investigational Site
Hamilton, Ontario, L8L 5G8
GSK Investigational Site
Houston, New Brunswick, E6E 1H1
GSK Investigational Site
Hull, Quebec, J8Y 2E2
GSK Investigational Site
Innisfil, Ontario, L9S 1L2
GSK Investigational Site
Kelowna, British Columbia, V1Y 3G8
GSK Investigational Site
Kingston, Ontario, K7M 1W9
GSK Investigational Site
Lambton, Quebec, G0M 1H0
GSK Investigational Site
Lle Perrot, Quebec, H8Y 3J2
GSK Investigational Site
London, Ontario, N5Y 3J8
GSK Investigational Site
London, Ontario, N6P 1A9
GSK Investigational Site
Longueuil, Quebec, J4J 3X5
GSK Investigational Site
Longueuil, Quebec, J4N 1E1
GSK Investigational Site
Longueuil, Quebec, J4N 1L6
GSK Investigational Site
Medicine Hat, Alberta, T1A 6N9
GSK Investigational Site
Mississauga, Ontario, L5B 3A8
GSK Investigational Site
Mississauga, Ontario, L5B 4A9
GSK Investigational Site
Montreal, Quebec, H1M 2M1
GSK Investigational Site
Montreal, Quebec, H4N 2W2
GSK Investigational Site
Neguac, New Brunswick, E9G 4H3
GSK Investigational Site
North York, Ontario, M3M 3E5
GSK Investigational Site
Oakville, Ontario, L6L 2X4
GSK Investigational Site
Oshawa, Ontario, L1H 1C2
GSK Investigational Site
Ottawa, Ontario, K2G 6E2
GSK Investigational Site
Peterborough, Ontario, K9H 1T6
GSK Investigational Site
Pierrefonds, Quebec, H8Y 3J2
GSK Investigational Site
Pointe-Claire, Quebec, H9R 3J1
GSK Investigational Site
Québec, G1N 1E1
GSK Investigational Site
Rexdale, Ontario, M9V 4B9
GSK Investigational Site
Richelieu, Quebec, J3L 4W6
GSK Investigational Site
Richmond Hill, Ontario, L4C 2N9
GSK Investigational Site
Saint-Charles-Borromée, Quebec, J6E 5A9
GSK Investigational Site
Saint-Jean-sur-Richelieu, Quebec, J2X 2B2
GSK Investigational Site
Saint-Léonard, Quebec, H1S 3A9
GSK Investigational Site
Sainte-Anne-de-Bellevue, Quebec, H9X 1M2
GSK Investigational Site
Sainte-Catherine, Quebec, J0L 1E0
GSK Investigational Site
Sainte-Foy, Quebec, G1V 1V6
GSK Investigational Site
Sainte-Henri de Levis, Quebec, G0R 3E0
GSK Investigational Site
Salaberry-de-Valleyfield, Quebec, J6S 4Z5
GSK Investigational Site
Saskatoon, Saskatchewan, S7K 1N4
GSK Investigational Site
Saskatoon, Saskatchewan, S7L 2W1
GSK Investigational Site
Saskatoon, Saskatchewan, S7M 0Z6
GSK Investigational Site
Scarborough Village, Ontario, M1J 2E5
GSK Investigational Site
Scarborough Village, Ontario, M1R 1R9
GSK Investigational Site
Smiths Falls, Ontario, K7A 2H6
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1B 2X2
GSK Investigational Site
Sutton, Ontario, L0E 1R0
GSK Investigational Site
Thetford-Mines, Quebec, G6G 6H1
GSK Investigational Site
Toronto, Ontario, M2M 4J5
GSK Investigational Site
Toronto, Ontario, M5G 1E2
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
GSK Investigational Site
Upper Tantallon, Nova Scotia, B3Z 4R4
GSK Investigational Site
Vancouver, British Columbia, V5P 3T7
GSK Investigational Site
Vancouver, British Columbia, V5X 3T5
GSK Investigational Site
Vancouver, British Columbia, V7N 4M2
GSK Investigational Site
Vaudreuil, Quebec, J7V 8P9
GSK Investigational Site
Ville Lasalle, Quebec, H8N 1X9
GSK Investigational Site
Windsor, Ontario, B0N 2T0
GSK Investigational Site
Winnipeg, Manitoba, R2H 0R8
GSK Investigational Site
Winnipeg, Manitoba, R2J 4A7
GSK Investigational Site
Winnipeg, Manitoba, R3A 1M3
GSK Investigational Site
Woodbridge, Ontario, L4L 8E2
GSK Investigational Site
Woodstock, Ontario, E7M 1H1
GSK Investigational Site
Woodstock, Ontario, N4S 4H4
About this study
Official title: AVANDAMET Compared to Metformin Evaluation Trial (ACME): A 48-week Randomized, Open-label, Multicenter Study to Compare the Efficacy and Tolerability of AVANDAMET to Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Control on Submaximal Metformin.
This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- rosiglitazone/metformin
- Keywords
- Metformin, AVANDAMET, 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/metforminDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c at week 48.
Secondary outcomes (1)
Change from baseline in FPG at week 48. Time to glycemic control. Change from baseline in C-peptide and insulin at week 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study start25 Jun 2003
- Primary completion1 Dec 2005
- Study completion16 Dec 2005
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants
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
- NCT00241605
- Sponsor's protocol ID
- 712753/008
- Status last verified
- Mar 2018
- First submitted
- 17 Oct 2005
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
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
- AVANDAMET Compared to Metformin Evaluation Trial (ACME): A 48-week Randomized, Open-label, Multicenter Study to Compare the Efficacy and Tolerability of AVANDAMET to Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Control on Submaximal Metformin.
- ClinicalTrials.gov ID
- NCT00241605
- Acronym / sponsor ID
- 712753/008
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Metformin, AVANDAMET, Type 2 diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2003
- Primary completion
- 1 Dec 2005 (actual)
- Study completion
- 16 Dec 2005 (actual)
- First posted
- 19 Oct 2005 (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.
This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between 18 and 75 years of age with Type 2 Diabetes Mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).
- Patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.
- Women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.
Key exclusion criteria (8 listed)
- Prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
- Have a known hypersensitivity to thiazolidinediones or biguanides.
- Currently using insulin or any oral anti-diabetic agent other than metformin.
- History of metabolic acidosis.
- History of substance abuse.
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
Change from baseline in HbA1c at week 48.
1 secondary outcome
Change from baseline in FPG at week 48. Time to glycemic control. Change from baseline in C-peptide and insulin at week 48.
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.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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
91 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rosiglitazone/metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 91 sites in Canada.
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 8 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 91 sites in Canada. 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 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?
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 HbA1c at week 48.. 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.