Clinical trial NCT00241605: AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Metformin
AVANDAMET
Type 2 diabetes
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-10-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline in HbA1c at week 48.
Secondary outcomes:
measure: Change from baseline in FPG at week 48. Time to glycemic control. Change from baseline in C-peptide and insulin at week 48.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Medicine Hat
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Aldergrove
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Kelowna
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Fredericton
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Houston
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Neguac
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Bay Roberts
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Carbonear
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Saint John's
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Saint John's
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Dartmouth
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Upper Tantallon
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Ajax
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Burlington
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Cambridge
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Fort Erie
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Innisfil
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: North York
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Rexdale
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Richmond Hill
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Scarborough
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Scarborough
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Smiths Falls
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sutton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Woodbridge
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Woodstock
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Woodstock
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Brossard
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Charlesbourg
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Charlesbourg
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Chateauguay
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Courcelette
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Cowansville
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Hull
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Lambton
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Lle Perrot
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Longueuil
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Longueuil
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Longueuil
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Pierrefonds
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Richelieu
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Saint Charles Borromee
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Saint Leonard
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Saint-Jean sur Richelieu
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte Anne De Bellevue
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte Catherine
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte-Henri De Levis
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Salaberry-De-Valleyfield
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Thetford Mines
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Vaudreuil
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Ville Lasalle
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: GSK Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: GSK Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: GSK Investigational Site
state: Saskatchewan
city: Québec
country: Canada
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: