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Levemir-Body Composition and Energy Metabolism

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ClinicalTrials.gov Identifier: NCT00862875
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : May 7, 2014
Sponsor:
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  ICMJE March 16, 2009
First Posted Date  ICMJE March 17, 2009
Last Update Posted Date May 7, 2014
Study Start Date  ICMJE March 2009
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2009)
Changes in total fat mass (in kg) [ Time Frame: Baseline and 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Levemir-Body Composition and Energy Metabolism
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2014)
42
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2009)
80
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00862875
Other Study ID Numbers  ICMJE RRL-01-2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
Study Sponsor  ICMJE Institut de Recherches Cliniques de Montreal
Collaborators  ICMJE
  • Novo Nordisk A/S
  • McMaster University
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP