Clinical trial NCT00862875: Levemir-Body Composition and Energy Metabolism
Official title: Effects of Basal Insulin Analogue Detemir on Body Composition, Epicardial Fat and Energy Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Insulin initiation
oral therapy failure
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
name: McMaster University
First posted: 2009-03-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


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.

Primary outcomes:
measure: Changes in total fat mass (in kg)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Epicardial fat, trunk fat, total fat free mass, weight & waist circumference, HbA1c, fasting glucose, RMR, TEF,PAEE & TEE, energy intake.
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Institut de Recherches Cliniques de Montréal
state: Quebec
Study officials:
affiliation: Institut de recherches cliniques de Montréal
name: Remi Rabasa-Lhoret, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: