Levemir-Body Composition and Energy Metabolism

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

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 .

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Detemir or Glargine

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2W 1R7
      • Institut de Recherches Cliniques de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1:Insulin detemir; Insulin detemir (Levemir® - Novolin® 4 pen)	Drug: Detemir or Glargine; 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.; Other Names: Lantus; Levemir; Detemir; Long acting insulin; Bed time insulin; basal insulin analogue
Active Comparator: 2:Insulin Glargin; Insulin glargine (Lantus® - Solostar®)	Drug: Detemir or Glargine; 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.; Other Names: Lantus; Levemir; Detemir; Long acting insulin; Bed time insulin; basal insulin analogue

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Institut de Recherches Cliniques de Montreal
• Collaborators: Novo Nordisk A/S; McMaster University

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: March 16, 2009
• First Submitted That Met QC Criteria: March 16, 2009
• First Posted (Estimate): March 17, 2009

Study Record Updates

• Last Update Posted (Estimate): May 7, 2014
• Last Update Submitted That Met QC Criteria: May 6, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Insulin initiation; oral therapy failure
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin, Long-Acting; Insulin Detemir
• Other Study ID Numbers: RRL-01-2009