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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
| McMaster University | OTHER |
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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1:Insulin detemir | Experimental | Insulin detemir (Levemir® - Novolin® 4 pen) |
|
| 2:Insulin Glargin | Active Comparator | Insulin glargine (Lantus® - Solostar®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Detemir or Glargine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in total fat mass (in kg) | Baseline and 6 months |
| Measure | Description | 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Remi Rabasa-Lhoret, MD, PhD | Institut de Recherches Cliniques de Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Recherches Cliniques de Montréal | Montreal | Quebec | H2W 1R7 | Canada |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| D000069036 | Insulin Glargine |
| D049528 | Insulin, Long-Acting |
| ID | Term |
|---|---|
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| D004700 | Endocrine System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |