Levemir-Body Composition and Energy Metabolism

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Detemir or Glargine

• Registration Number: NCT00862875
• Lead Sponsor: Institut de Recherches Cliniques de Montreal

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-16
• Study First Posted: 2009-03-17
• Primary Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-06
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2:Insulin Glargin	Detemir or Glargine	Insulin glargine (Lantus® - Solostar®)
1:Insulin detemir	Detemir or Glargine	Insulin detemir (Levemir® - Novolin® 4 pen)

Primary Outcome Measures

Name	Time	Method
Changes in total fat mass (in kg)	Baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
Epicardial fat, trunk fat, total fat free mass, weight & waist circumference, HbA1c, fasting glucose, RMR, TEF,PAEE & TEE, energy intake.	Baseline and 6 months

Trial Locations

Locations (1)

Institut de Recherches Cliniques de Montréal; 🇨🇦 Montréal, Quebec, Canada