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

Sponsor

Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01310452

Collaborator

Novo Nordisk A/S (Industry)

Enrollment

Location

Arms

Study Details

Study Description

Brief 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:

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

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 or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: insulin detemir Drug: neutral protamine insulin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The change in liver fat content and visceral fat mass [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

Secondary Outcome Measures

MRI [after 26 weeks of treatment]
Abdominal subcutaneous fat mass(cm2), Calculated Visceral/Subcutaneous Adipose Tissue Ratio.
Change in HbA1c [from baseline to 12 and 26 weeks of treatment respectively]
Change in HbA1c from baseline at 12 and 26 weeks of treatment respectively
Change in Fasting plasma glucose [From baseline to 12 and 26 weeks]
Change in Fasting plasma glucose (FPG) from baseline at 12 and 26 weeks of treatment respectively
Weight at every visit [At every visit]
Weight at every visit
Waist and hip circumference at every visit [At every visit]
Waist and hip circumference at every visit
Hypoglycaemia [during the 26-week treatment]
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]
Lipid profile at the start and after 26 weeks of treatment
Adverse events [During the trial]
Incidence of Adverse events during the trial
Safety profile [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.