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

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring diabetes, basal insulin, metformin, liver fat, visceral fat Read More

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.