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

March 7, 2011 updated by: Fudan University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shang hai, China
        • Zhong Shan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
  • Female or male, 18 years≤age≤70years
  • Subjects with insulin naïve type 2 diabetes who have been treated with metformin（>1g/d）alone for at least 3 months prior to screening
  • 11%≥HbA1c≥7.5% based on analysis from a central laboratory
  • 24kg/m2≤BMI≤40kg/m2
  • Weight fluctuation<2kg in one month prior to screening
  • Able and willing to perform self-monitoring of blood glucose.
  • Willing to accept basal insulin therapy
  • Able to self-inject all required doses of insulin

Exclusion Criteria:

  • Treatment with any OADs (Oral Antidiabetic Drugs) in the last 6 months, except metformin (subjects currently treated with metformin within the interval of 1000-2000 mg daily may be included in the trial. The dose should have remained unchanged for a period of one month prior to randomisation and should be expected to remain unchanged throughout the trial period).
  • Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramine, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, NSAIDs, tricyclic anti-depressants, atypical anti-psychotics).
  • Participation in a clinical study of weight control within the last 3 months prior to screening.
  • Previous or planned surgical treatment of obesity.
  • Any disease or condition (such as renal, hepatic or cardiac) according to the judgment of the Investigator makes the subject unsuitable for participation in the trial.
  • Anticipated change in concomitant medication known to interfere with glucose metabolism, such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors.
  • Anticipated change in concomitant medication known to interfere with lipid metabolism, such as lipid-lowering drugs.
  • Proliferative retinopathy or maculopathy that has required acute treatment within the last six months.
  • Uncontrolled hypertension (treated or untreated) as judged by the Investigator
  • Known or suspected allergy to trial product(s) or related products.
  • Previous participation in this trial. Participation is defined as screened.
  • Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  • Any condition that the Investigator feels would interfere with trial participation or evaluation of results.
  • Receipt of any investigational drug (NPH or insulin detemir) within 1 month prior to this trial.
  • Cardiac disease defined according to NYHA class III or IV, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection.
  • History of hypoglycaemic unawareness.
  • With mental implant (such as cardiac pacemaker, insulin pump) in vivo.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: neutral protamine insulin, metformin
NPH insulin once daily plus oral metformin twice or thrice daily during 26 weeks
Drug: insulin detemir
insulin detemir once daily with metformin
Experimental: insulin detemir, metformin
Insulin detemir once daily plus oral metformin twice or thrice daily during 26 weeks
Drug: neutral protamine insulin
neutral protamine insulin once daily with metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in liver fat content and visceral fat mass
Time Frame: After 26 weeks of treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI
Time Frame: after 26 weeks of treatment
Abdominal subcutaneous fat mass(cm2), Calculated Visceral/Subcutaneous Adipose Tissue Ratio.
after 26 weeks of treatment
Change in HbA1c
Time Frame: from baseline to 12 and 26 weeks of treatment respectively
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
Time Frame: From baseline to 12 and 26 weeks
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
Time Frame: At every visit
Weight at every visit
At every visit
Waist and hip circumference at every visit
Time Frame: At every visit
Waist and hip circumference at every visit
At every visit
Hypoglycaemia
Time Frame: during the 26-week treatment
Incidence of hypoglycaemia in the 26 weeks of treatment with insulin detemir versus NPH
during the 26-week treatment
Lipid profile
Time Frame: At the start and after 26 weeks of treatment
Lipid profile at the start and after 26 weeks of treatment
At the start and after 26 weeks of treatment
Adverse events
Time Frame: During the trial
Incidence of Adverse events during the trial
During the trial
Safety profile
Time Frame: During the treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Study Registration Dates

First Submitted

March 7, 2011

First Submitted That Met QC Criteria

March 7, 2011

First Posted (Estimate)

March 8, 2011

Study Record Updates

Last Update Posted (Estimate)

March 8, 2011

Last Update Submitted That Met QC Criteria

March 7, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • prof gao xin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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