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Clinical Trial Details

Trial ID: L5655
Source ID: NCT01310452
Associated Drug: Insulin Detemir
Title: Study on Liver Fat Content and Visceral Fat Mass in Overweight and Obese Type 2 Diabetes Patients After Treatment With Basal Insulin
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: insulin detemir|DRUG: neutral protamine insulin
Outcome Measures: Primary: 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, After 26 weeks of treatment | Secondary: MRI, Abdominal subcutaneous fat mass(cm2), Calculated Visceral/Subcutaneous Adipose Tissue Ratio., after 26 weeks of treatment|Change in HbA1c, Change in HbA1c from baseline at 12 and 26 weeks of treatment respectively, 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, From baseline to 12 and 26 weeks|Weight at every visit, Weight at every visit, At every visit|Waist and hip circumference at every visit, Waist and hip circumference at every visit, At every visit|Hypoglycaemia, Incidence of hypoglycaemia in the 26 weeks of treatment with insulin detemir versus NPH, during the 26-week treatment|Lipid profile, Lipid profile at the start and after 26 weeks of treatment, At the start and after 26 weeks of treatment|Adverse events, Incidence of Adverse events during the trial, 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, During the treatment
Sponsor/Collaborators: Sponsor: Fudan University | Collaborators: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 50
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2011-01
Completion Date:
Results First Posted:
Last Update Posted: 2011-03-08
Locations: Zhong Shan Hospital, Fudan University, Shang hai, China
URL: https://clinicaltrials.gov/show/NCT01310452