A multi-centre, open-labelled, randomised, two-group parallel, treat-to-target trial comparing the weight change in overweight and obese subjects with type 2 diabetes after 26 weeks of treatment with insulin detemir once daily versus insulin NPH once daily, both with insulin aspart in the mealtime.(PREDICTIVE-BMI study) - PREDICTIVE-BMI study

Phase 1

• Conditions: Type 2 diabetes; MedDRA version: 7.0Level: PTClassification code 10049746

• Registration Number: EUCTR2005-000976-42-ES
• Lead Sponsor: ovo Nordisk Pharma S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-17
• Study Completion: 2006-12-21
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
2. Female or male, age =18
3. Subjects with type 2 diabetes who have been treated with 2 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion
4. HbA1c = 7.5 and = 11% based on analysis from central laboratory
5. BMI = 25 kg/m2 and = 40 kg/m2
6. Able and willing to perform self-monitoring of blood glucose.
7. Willing to accept multidose insulin therapy
8. Able to self-inject all required doses of insulin
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

1. Treatment with any OAD (Oral Antidiabetic Drugs), excepting metformin (subjects currently treated with metformin within the interval of 1000 - 2550 mg daily may be included in the trial. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period).
2. Any disease or condition (such as renal, hepatic or cardiac) that, according to the judgement of the Investigator, makes the subject unsuitable for participation in the trial.
3. Total daily insulin dose = 2 IU/kg.
4. Anticipated change in concomitant medication known to interfere with glucose metabolism, such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors.
5. Proliferative retinopathy or maculopathy that has required acute treatment within the last six months.
6. Uncontrolled hypertension (treated or untreated) as judged by the Investigator
7. Known or suspected allergy to trial product(s) or related products.
8. Previous participation in this trial. Participation is defined as screened.
9. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods.
10. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
11. Any condition that the Investigator feels would interfere with trial participation or evaluation of results.
12. Receipt of any investigational drug within 1 month prior to this trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified