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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Fudan University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01310452
First received: March 7, 2011
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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

Condition Intervention
Type 2 Diabetes Mellitus
Drug: insulin detemir
Drug: neutral protamine insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • The change in liver fat content and visceral fat mass [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • MRI [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
    Abdominal subcutaneous fat mass(cm2), Calculated Visceral/Subcutaneous Adipose Tissue Ratio.

  • Change in HbA1c [ Time Frame: from baseline to 12 and 26 weeks of treatment respectively ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline at 12 and 26 weeks of treatment respectively

  • Change in Fasting plasma glucose [ Time Frame: From baseline to 12 and 26 weeks ] [ Designated as safety issue: No ]
    Change in Fasting plasma glucose (FPG) from baseline at 12 and 26 weeks of treatment respectively

  • Weight at every visit [ Time Frame: At every visit ] [ Designated as safety issue: No ]
    Weight at every visit

  • Waist and hip circumference at every visit [ Time Frame: At every visit ] [ Designated as safety issue: No ]
    Waist and hip circumference at every visit

  • Hypoglycaemia [ Time Frame: during the 26-week treatment ] [ Designated as safety issue: Yes ]
    Incidence of hypoglycaemia in the 26 weeks of treatment with insulin detemir versus NPH

  • Lipid profile [ Time Frame: At the start and after 26 weeks of treatment ] [ Designated as safety issue: Yes ]
    Lipid profile at the start and after 26 weeks of treatment

  • Adverse events [ Time Frame: During the trial ] [ Designated as safety issue: No ]
    Incidence of Adverse events during the trial

  • Safety profile [ Time Frame: During the treatment ] [ Designated as safety issue: Yes ]
    Safety profile as measured by laboratory safety parameters (haematology, biochemistry) and physical examination/vital signs before and at the end of treatment


Estimated Enrollment: 50
Study Start Date: January 2011
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01310452

Locations
China
Zhong Shan Hospital, Fudan University
Shang hai, China
Sponsors and Collaborators
Fudan University
Novo Nordisk A/S
  More Information

Publications:

Responsible Party: Gao Xin/Professor, Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai 200032 China
ClinicalTrials.gov Identifier: NCT01310452     History of Changes
Other Study ID Numbers: prof gao xin
Study First Received: March 7, 2011
Last Updated: March 7, 2011
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
diabetes, basal insulin, metformin, liver fat, visceral fat

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
Insulin
Metformin
Insulin, Long-Acting
Protamines
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014