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

Tracking Information

• First Submitted Date: March 16, 2009
• First Posted Date: March 17, 2009
• Last Update Posted Date: May 7, 2014
• Study Start Date: March 2009
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 16, 2009): Changes in total fat mass (in kg) [ Time Frame: Baseline and 6 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: March 16, 2009): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Levemir-Body Composition and Energy Metabolism
• Official Title: Effects of Basal Insulin Analogue Detemir on Body Composition, Epicardial Fat and Energy Metabolism
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Type 2 Diabetes

Intervention

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

Study Arms

• Experimental: 1:Insulin detemir
  Insulin detemir (Levemir® - Novolin® 4 pen)
  Intervention: Drug: Detemir or Glargine
• Active Comparator: 2:Insulin Glargin
  Insulin glargine (Lantus® - Solostar®)
  Intervention: Drug: Detemir or Glargine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 6, 2014): 42
• Original Estimated Enrollment (submitted: March 16, 2009): 80
• Study Completion Date: Not Provided
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00862875
• Other Study ID Numbers: RRL-01-2009
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
• Study Sponsor: Institut de Recherches Cliniques de Montreal

Collaborators

• Novo Nordisk A/S
• McMaster University

Investigators

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

• PRS Account: Institut de Recherches Cliniques de Montreal
• Verification Date: May 2014