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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

Study Description
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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
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862875


Locations
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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
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Principal Investigator: Remi Rabasa-Lhoret, MD, PhD Institut de recherches cliniques de Montréal
More Information
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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    Key Record Dates
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:
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Insulin
Insulin, Globin Zinc
Insulin Detemir
 Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs