Status:
COMPLETED
Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study)
Lead Sponsor:
Canadian Heart Research Centre
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes Association guidelines glucose control, based on the A1C measurement, needs to be achieved within a 6-12 mont...
Detailed Description
AvandametTM combines two oral antihyperglycemic agents, rosiglitazone maleate and metformin hydrochloride, with different but complementary mechanisms of action to improve glycemic control while reduc...
Eligibility Criteria
Inclusion
- Type 2 diabetes patients
- 18 - 75 years old
- Type 2 diabetes mellitus (DM) drug naïve or on submaximal oral monotherapy \< 3 years
- A1C criteria at screening:
- 7.1-10% for drug naïve patients after failure of diet control and life-style modification
- 7.1 - 9% on single therapy (e.g. not more 10 mg of Glyburide or 4 mg of Amaryl™ or 1000mg of Metformin) who will start after 2 weeks wash-out. During wash out the following will be done: i) diet and life style modification ii) Angiotensin converting enzyme inhibitor (ACE), aspirin (80 mg), and statin if appropriate
- Signed informed consent
Exclusion
- Type 1 diabetes
- Subjects currently treated with insulin
- Subject treated for previous 3 month with any thiazolidinedione (TZD)
- Evidence of clinically significant concomitant illnesses which are not controlled by medication and/or may limit participation in the study as judged by the investigator
- Subjects who have hypersensitivity to any components of study drugs
- Participation in a clinical trial and/or intake of an investigational drug within 30 days prior to screening.
- Pregnant or nursing females
- Females of childbearing potential who are not on adequate birth control
- Liver enzymes (Alanine Aminotransferase (ALT) \> 2.5 times upper limit of normal)
- Renal impairment: serum creatinine ≥ 136umol/L (males) and ≥ 124 umol/L (females)
- Congestive Heart Failure (CHF class III/IV)
- Weight \>160 kg
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
391 Patients enrolled
Trial Details
Trial ID
NCT00131664
Start Date
September 1 2005
End Date
January 1 2008
Last Update
April 17 2013
Active Locations (1)
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1
Canadian Heart Research Centre
Toronto, Ontario, Canada, m5b 2p9