Study on Liver Fat Content and Visceral Fat Mass in Overweight and Obese Type 2 Diabetes Patients After Treatment With Basal Insulin

• Status: Unknown status
• Trial end date: 1969-12-31

Summary

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

• Phase: N/A

Details

• Lead Sponsor: Fudan University
• Collaborator: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir; Insulin, Globin Zinc; Metformin; Protamines