Levemir-Body Composition and Energy Metabolism

Institut de Recherches Cliniques de Montreal

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Detemir or Glargine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00862875

RRL-01-2009

Details and patient eligibility

About

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 .

Enrollment: 42 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

1:Insulin detemir

Experimental group

Description:

Insulin detemir (Levemir® - Novolin® 4 pen)

Treatment:

Drug: Detemir or Glargine

2:Insulin Glargin

Active Comparator group

Description:

Insulin glargine (Lantus® - Solostar®)

Treatment:

Drug: Detemir or Glargine