Type 2 Diabetes Mellitus MedDRA version: 9.1 Level: LLT Classification code 10053247 Term: Insulin-requiring type 2 diabetes mellitus
Conditions
Interventions
Trade Name: Levemir
Pharmaceutical Form: Solution for injection
Trade Name: Insulatard
Pharmaceutical Form: Suspension for injection
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Sponsors
University of Surrey
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Informed consent 2. Type 2 diabetes mellitus 3. Treated with metformin 4. Already on treatment with twice-daily NPH insulin with or without short-acting insulin or a 'basal-bolus' regimen 5. Above 18 years of age 6. BMI 27-35 7. Able and willing to perform own blood glucose monitoring 8. Able and willing to maintain consistent eating habits throughout the entire study period 9. Able and willing to maintain consistent physical activity throughout the entire study period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients on sulphonylureas or thiazolidinediones 2. Proliferative retinopathy that has required acute treatment in the last 6 months 3. Impaired hepatic or renal function 4. Cardiac problems 5. Uncontrolled hypertension 6. Mental incapacity, unwillingness or a language barrier precluding adequate understanding or co-operation 7. Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effects of treatment with insulin detemir for 16 weeks with the effects of treatment with NPH insulin for 16 weeks on energy expenditure.; Secondary Objective: To compare the above 2 treatments in terms of outcome with respect to: body weight waist-hip ratio achieved glycaemic control ;Primary end point(s): Energy expenditure after the 24-week treatment period. | — |
Countries
United Kingdom
Outcome results
None listed