Levemir-Body Composition and Energy Metabolism

• ClinicalTrials.gov Identifier: NCT00862875
• Recruitment Status: Completed
• First Posted: March 17, 2009
• Last Update Posted: May 7, 2014
• Sponsor: Institut de Recherches Cliniques de Montreal
• Collaborators: Novo Nordisk A/S; McMaster University
• Information provided by (Responsible Party): Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

Study Description

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 .

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes	Drug: Detemir or Glargine	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Basal Insulin Analogue Detemir on Body Composition, Epicardial Fat and Energy Metabolism
• Study Start Date: March 2009
• Actual Primary Completion Date: April 2014

Arms and Interventions

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: Detemir; Levemir; Long acting insulin; Bed time insulin; Lantus; 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: Detemir; Levemir; Long acting insulin; Bed time insulin; Lantus; basal insulin analogue

Outcome Measures

Primary Outcome Measures :

1. Changes in total fat mass (in kg) [ Time Frame: Baseline and 6 months ]

Secondary Outcome Measures :

1. Epicardial fat, trunk fat, total fat free mass, weight & waist circumference, HbA1c, fasting glucose, RMR, TEF,PAEE & TEE, energy intake. [ Time Frame: Baseline and 6 months ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Canada, Quebec

Institut de Recherches Cliniques de Montréal

Montréal, Quebec, Canada, H2W 1R7

Sponsors and Collaborators

Institut de Recherches Cliniques de Montreal

Novo Nordisk A/S

McMaster University

Investigators

• Principal Investigator: Remi Rabasa-Lhoret, MD, PhD; Institut de recherches cliniques de Montréal

More Information

• Responsible Party: Rémi Rabasa-Lhoret, MD, PhD, Institut de Recherches Cliniques de Montreal
• ClinicalTrials.gov Identifier: NCT00862875
• Other Study ID Numbers: RRL-01-2009
• First Posted: March 17, 2009
• Last Update Posted: May 7, 2014
• Last Verified: May 2014

Keywords provided by Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal:

Insulin initiation; oral therapy failure

Additional relevant MeSH terms:

Insulin; Insulin, Globin Zinc; Insulin Detemir; Insulin, Long-Acting; Hypoglycemic Agents; Physiological Effects of Drugs