Effects of Rosiglitazone and Metformin on Metabolism in Type 2 Diabetes
Condition: Insulin Sensitivity; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Insulin resistance is a pivotal underlying metabolic abnormality in most subjects with type 2
      diabetes. Clinical experience has proved metformin to be efficacious treatment in patients
      with type 2 diabetes. Rosiglitazone is a novel antidiabetic agent, which has been shown to
      decrease fasting plasma glucose concentrations in animal models and in clinical trials. There
      are no previous studies that compare the effects of rosiglitazone and metformin on insulin
      stimulated glucose uptake in subjects with type 2 diabetic in different organs.

      PET is very sensitive in detecting changes in glucose uptake and blood flow and, is the
      method of choice to investigate the effects of medical interventions. Due to sensitivity of
      these functional parameters only moderate or small number of subjects need to be studied.
      This makes it feasible to perform tightly controlled intervention studies in a very
      cost-effective way.

      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. PET measurements on
      myocardium, skeletal muscle and subcutaneous and visceral fat are performed at baseline and
      at the end of the treatment period. Furthermore, the effect of exercise on skeletal muscle
      blood flow and glucose uptake is studied.

      The study consists of 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. The investigators will also study ten
      age-matched non-diabetic control subjects, who will undergo the same PET study procedure as
      subjects with type 2 diabetes.

      A study of the effects of antidiabetic oral medication in newly diagnosed subjects with type
      2 diabetes is of great importance for the understanding of the differences in mode of action
      of the different antidiabetic drugs. Such a study would contribute to elucidate advantages
      and disadvantages with certain drugs and potential additive effects in combination therapy.
    

Intervention name(s): Rosiglitazone; Metformin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients received either placebo, metformin or rosiglitazone; Patients received either placebo, metformin or rosiglitazone; Patients received either placebo, metformin or rosiglitazone
Other intervention name(s): Avandia
Intervention MeSH terms: Metformin; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rosiglitazone; metformin; muscle