Effects of Rosiglitazone and Metformin on Metabolism in Type 2 Diabetes

• Status: Completed
• Trial end date: 2001-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this study are to compare the effects of rosiglitazone and metformin on insulin stimulated glucose uptake in subjects with type 2 diabetes. Whole body, and skeletal muscle, heart and adipose tissue insulin stimulated glucose uptake is measured during euglycemic hyperinsulinemic clamp and positron-emission tomography scanning before and 26 weeks after treatment in 48 newly diagnosed subjects with type 2 diabetes. Subjects will be randomized to receive either rosiglitazone or metformin or placebo, according to a simple randomization procedure with double blinding.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Turku University Hospital
• Collaborator: SmithKline Beecham
• Treatments: Metformin; Rosiglitazone

Criteria

Inclusion Criteria:

• Age 40-75 years,

• BMI 25-35 kg/m2,

• WHO criteria for type 2 diabetes fasting plasma glucose>=7.0 mmol/l on at least 2 separate occasions,

• C-peptide>0.2 nmol/l

Exclusion Criteria:

• plasma glucose < 6.1 or >10 mmol/l after the screening period

• cardiac heart failure

• diagnosed coronary heart disease

• severe aortic, mitral or tricuspidal valve disease

• blood pressure > 160/ 100 mg Hg

• any previous or present hepatic (GT >100, alanine amino transferase >3 x upper limit of the reference range) or renal (S-creatinine > 130) disease

• pregnancy or lactation

• proliferative retinopathy

• microalbuminuria

• subjects with history of lactate acidosis

• symptomatic polyneuropathy

• antidiabetic medication

• changes in antihypertensive medication or beta-blockers in medication

• metal objects in region of imaging

• anemia with Hb < 100 in mean or < 90 in women

• oral corticosteroid treatment