Status:
COMPLETED
Levemir-Body Composition and Energy Metabolism
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Collaborating Sponsors:
Novo Nordisk A/S
McMaster University
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 insu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00862875
Start Date
March 1 2009
Last Update
May 7 2014
Active Locations (1)
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1
Institut de Recherches Cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7