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< clinical trials / Avalanche

Clinical Trial Name:
Avandia (TM) + Amaryl(TM) or Avandamet(TM) Compared with Metformin (AVALANCHE Study): A 48-week Randomized, Open-label, Multicentre Study to Compare the Effectiveness of First-Line Combination Therapy to Monotherapy in Type 2 Diabetes Mellitus Patients

Status: Enrolling patients CLOSED (Analysing data)

FDA Clinical Trial number: NCT00131664

Brief description:  
Type 2 diabetes mellitus (T2DM) is a progressive disease. Insulin resistance worsens and pancreatic beta cell function decreases over time, making disease management progressively more difficult. Combination therapy using two or more drugs with different modes of action therefore appears to be a reasonable approach for treatment of patients with T2DM.This study will evaluate the effectiveness of 2 types of first-line oral combination therapy instead of Metformin monotherapy to achieve the above-mentioned glycemic target(s) in this open-label randomized clinical trial.

Eligibility:  
Subjects with drug naïve diabetic type 2 patients who failed on diet control and life-style modifications will be enrolled. Recently treated subjects (up to 3 years on single therapy of low to moderate dose of Glyburide or Amaryl(TM) or Metformin) will be also allowed to enter the study after 2-week wash-out period.

Inclusion criteria:

• Type 2 diabetes patients
• 18 - 75 years old
• T2DM diagnosed within previous 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 oral monotherapy (e.g. not more 10 mg of Glyburide or 4 mg of Amaryl(TM) or 1000mg of Metformin) requiring 2-week wash-out
• Signed informed consent

exclusion criteria:

• Type 1 diabetes
• Subjects currently treated with insulin
• Subject treated for previous 3 month with 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 any investigational drug within the previous 30 days prior to screening.
• Females of childbearing potential who are not on adequate birth control
• Liver enzymes > 2.5 times upper limit of normal
• Renal impairment: serum creatinine >=136umol/L (males) and >=124 umol/L (females)
• CHF class III/IV
• Weight >160 kg

Sponsor(s):
 Canadian Heart Research Centre (research grant provided by GSK)