A 20 week multi-national, open-labelled, randomised, three-group parallel trial comparing administration of insulin detemir morning, insulin detemir evening and NPH insulin evening as add-on to oral antidiabetic drug(s) in subjects with type 2 diabetes
- Conditions
- Type 2 DiabetesMedDRA version: 7.0Level: PTClassification code 10049746
- Registration Number
- EUCTR2004-001461-18-ES
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
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.Type 2 diabetes according to clinical judgement.
3.Duration of type 2 diabetes =12 months.
4.Insulin naïve subjects. Previous short-term insulin treatment (seven days or less) is allowed.
5. Currently on any oral antidiabetic drug (OAD) = 3 months according to the following:
• Countries where the combination of insulin and TZD is not approved:
? OAD monotherapy, except TZD or alpha-glucosidase inhibitors
? OAD combination therapy, except the combination of TZD and alpha-glucosidase inhibitors
• Countries where the combination of insulin and TZD is approved:
? Any OAD treatment except monotherapy with alpha-glucosidase inhibitors
6. The dose of the individual OAD must be either highest tolerated dose or at least half maximum recommended dose according to local labelling = 3 months prior to screening.
7. The OAD dose(s) must be unchanged for the last month prior to screening.
8. Age = 18 years, females and males.
9. Body mass index (BMI) = 40.0 kg/m2.
10. HbA1c = 7.5 and =11.0% at screening based on analysis from the central laboratory.
11. Able and willing to use daily injections of insulin for the entire trial period.
12. Able and willing to perform self-monitoring of plasma glucose according to the protocol
Are the trial subjects under 18?
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
1.Previous participation in this trial. Participation is defined as screened.
2.Previous acute treatment with insulin > 7 days.
3.Treatment with TZD and/or other OAD(s) which does not adhere to the approved labelling for the respective country.
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.Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator.
7.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.
8.Uncontrolled hypertension (treated or untreated) as judged by the investigator.
9.Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation.
10.Known or suspected allergy to trial product(s) or related products.
11.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. In Denmark and France barrier methods are not accepted as adequate contraceptives.
12.The receipt of any investigational drug within one month prior to this trial.
13.Any condition that the Investigator feels would interfere with trial participation or evaluation of results.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method