Type 2 Diabetes
Conditions
Keywords
Insulin initiation, oral therapy failure
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 .
Interventions
DRUGDetemir 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.
Sponsors
Novo Nordisk A/S
McMaster University
Institut de Recherches Cliniques de Montreal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in total fat mass (in kg) | Baseline and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Epicardial fat, trunk fat, total fat free mass, weight & waist circumference, HbA1c, fasting glucose, RMR, TEF,PAEE & TEE, energy intake. | Baseline and 6 months |
Countries
Canada
Outcome results
None listed