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

NCT01310452 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-03-08

No results posted yet for this study

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

Conditions

Interventions

DRUG

insulin detemir

insulin detemir once daily with metformin

DRUG

neutral protamine insulin

neutral protamine insulin once daily with metformin

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01310452 on ClinicalTrials.gov