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More info
You can access this
clinical trial
if you have
Type 2 Diabetes Mellitus
and you are
between 18 and 70
years old
-
The phase for this study is not defined.
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The purpose

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

Provided treatments

  • Drug: insulin detemir
  • Drug: neutral protamine insulin

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01310452. The sponsor of the trial is Fudan University and it is looking for 50 volunteers for the current phase.
Official trial 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