Levemir-Body Composition and Energy Metabolism

Type 2 Diabetes Clinical Trial

Official title:

Effects of Basal Insulin Analogue Detemir on Body Composition, Epicardial Fat and Energy Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862875
• Other study ID #: RRL-01-2009
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2009
• Last updated: May 6, 2014
• Start date: March 2009

Study information

• Verified date: May 2014
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Canada	Institut de Recherches Cliniques de Montréal	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal	McMaster University, Novo Nordisk A/S

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in total fat mass (in kg)		Baseline and 6 months	No
Secondary	Epicardial fat, trunk fat, total fat free mass, weight & waist circumference, HbA1c, fasting glucose, RMR, TEF,PAEE & TEE, energy intake.		Baseline and 6 months	No