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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
50
insulin detemir once daily with metformin
neutral protamine insulin once daily with metformin
Zhong Shan Hospital, Fudan University
Shanghai, China
The change in liver fat content and visceral fat mass
To compare the change in liver fat content and visceral fat mass (cm2), assessed by MRS and MRI, after 26 weeks of treatment with insulin detemir or insulin NPH (both with metformin) in overweight and obese type 2 diabetic subjects
Time frame: After 26 weeks of treatment
MRI
Abdominal subcutaneous fat mass(cm2), Calculated Visceral/Subcutaneous Adipose Tissue Ratio.
Time frame: after 26 weeks of treatment
Change in HbA1c
Change in HbA1c from baseline at 12 and 26 weeks of treatment respectively
Time frame: from baseline to 12 and 26 weeks of treatment respectively
Change in Fasting plasma glucose
Change in Fasting plasma glucose (FPG) from baseline at 12 and 26 weeks of treatment respectively
Time frame: From baseline to 12 and 26 weeks
Weight at every visit
Weight at every visit
Time frame: At every visit
Waist and hip circumference at every visit
Waist and hip circumference at every visit
Time frame: At every visit
Hypoglycaemia
Incidence of hypoglycaemia in the 26 weeks of treatment with insulin detemir versus NPH
Time frame: during the 26-week treatment
Lipid profile
Lipid profile at the start and after 26 weeks of treatment
Time frame: At the start and after 26 weeks of treatment
Adverse events
Incidence of Adverse events during the trial
Time frame: During the trial
Safety profile
Safety profile as measured by laboratory safety parameters (haematology, biochemistry) and physical examination/vital signs before and at the end of treatment
Time frame: During the treatment
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