Levemir-Body Composition and Energy Metabolism

Study Overview
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Brief Summary
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The objectives is to compare the changes in body composition (primary objective), diabetes parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin® 4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and insulin secretagogues (SU) between baseline and after 6 months of insulin therapy in 80 type 2 diabetic patients failing on oral diabetic agents .

Official Title
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Effects of Basal Insulin Analogue Detemir on Body Composition, Epicardial Fat and Energy Metabolism

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Detemir or Glargine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetic patients who require basal (long-acting) insulin for the control of hyperglycemia according to the opinion of the investigator. Inadequate Glucose control: Hemoglobin A1c (HbA1c) percentage in the range of ≥ 7.5 - 12.0% Stable body weight for previous 3 months (± 5 kg). Structured exercise lower than 4 hours per week. Metformin ≥1.5 g/day Exclusion Criteria: Any medical, social or geographic condition, which, in the opinion of the investigator would not allow safe or reliable completion of the protocol. Type 1 Diabetes Mellitus Previous treatment with insulin (< 6 months prior inclusion). Insulin therapy for less than 6 days at the time of an acute event is acceptable. Secondary diabetes mellitus (i.e. steroid induced, Cushing syndrome, chronic pancreatitis, cystic fibrosis, etc.) and maturity-onset diabetes of the young Proliferative retinopathy/maculopathy requiring treatment Hypoglycemia unawareness or recurrent major hypoglycaemia Pregnancy and breast-feeding Unstable coronary artery disease Heart Failure as defined by class IV according to NYHA classification Recent (< 6 months) history of myocardial infarction, stroke or T.I.A, ventricular arrhythmias, or unstable supra-ventricular arrhythmias. Renal Insufficiency. Creatinine clearance < 40 ml/min (MDRD formula). Acute (< 2 months) or Chronic infectious diseases requiring either hospitalization or antibiotic treatment for more than 2 weeks Recent (< 1 year) diagnosis of systemic malignancies except thyroid and skin cancer Major psychiatric diseases History of drug addiction Previous bariatric surgery Medication that affects weight such as Systemic corticosteroids (prednisone) Anti-obesity medication (Xenical® or Meridia®) Megace ® Antidepressant medication associated with significant weight impact such as Zyprexa®, Remeron® based on investigator judgment. Growth hormone therapy or testosterone supplementation should be initiated for at least 6 months and at stable dose for 3 months prior to enrolment Medication that affects glycemic control and hypoglycemic unawareness based on investigator judgment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1:Insulin detemir<br>Insulin detemir (Levemir® - Novolin® 4 pen) | Drug: Detemir or Glargine<br>* Initial dose of 10 units of insulin at bedtime. The insulin dose will be increase by 1 unit per day until fasting plasma glucose (FPG) levels are 5.0 mmol/L.<br>* Other names: basal insulin analogue;|
| Active Comparator: 2:Insulin Glargin<br>Insulin glargine (Lantus® - Solostar®) | Drug: Detemir or Glargine<br>* Initial dose of 10 units of insulin at bedtime. The insulin dose will be increase by 1 unit per day until fasting plasma glucose (FPG) levels are 5.0 mmol/L.<br>* Other names: basal insulin analogue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in total fat mass (in kg) |  | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epicardial fat, trunk fat, total fat free mass, weight & waist circumference, HbA1c, fasting glucose, RMR, TEF,PAEE & TEE, energy intake. |  | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin initiation, oral therapy failure