Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Multi-centre, Open-labeled, Randomized, Parallel Study on Liver Fat Content and Visceral Fat Mass in Overweight and Obese Type 2 Diabetes Patients After 26 Weeks Treatment With Insulin Detemir Once Daily Versus Insulin NPH Once Daily
Primary objective:
To compare the change in liver fat content and visceral fat mass (cm2) assessed by MRS
(Magnetic Resonance Spectroscopy) and MRI (Magnetic Resonance Image), after 26 weeks of
treatment with insulin detemir once daily or insulin NPH once daily both with metformin in
overweight and obese type 2 diabetic subjects.
Secondary objectives:
To compare the two treatments with respect to:
1. Efficacy:
- MRI: abdominal subcutaneous fat mass(cm2), Calculated Visceral/Subcutaneous
Adipose Tissue Ratio.
- Change in HbA1c from baseline at 12 and 26 weeks of treatment.
- Change in Fasting plasma glucose from baseline at 12 and 26 weeks of treatment.
- Weight
- Waist and hip circumference
2. Safety:
- Incidence of hypoglycaemia in the 26 weeks of treatment with insulin detemir
versus NPH
- Lipid profile at the start and after 26 weeks of treatment
- Incidence of Adverse events during the trial
- Safety profile as measured by laboratory safety parameters (haematology,
biochemistry) and physical examination/vital signs before and at the end of
treatment
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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