Weight gain, eating patterns and development of body composition during initiation of basal insulin therapy: a comparison of insulin determir and insulin glargine

• Conditions: Typ 2 diabetes; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2007-000353-65-DE
• Lead Sponsor: niversity Hospital Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-18
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

- Age > 18 years and < 80 years
- Gender: female, male
- Type 2 diabetes
- BMI: 20.0 – 38.0 (higher, if MRI is possible)
- Anti-GAD antibody negative
- Fasting blood glucose > 126 mg/dl
- HbA1c 7.0 – 11.0%
- Previous therapy with metformin or sulfonylurea or glinide or a combination of metformin with sulfonyurea or metformin with glinide.
- Minimal dose per day: 3.5mg Glibenclamid, 3mg Glimepirid, at least 1500mg Metformin, 3mg Repaglinid, 300mg Nateglinid, 60mg Gliclazid MR
- Stable oral therapy for at least 3 months
- Female patients must have a negative urine pregnancy test prior to study entry and must be either at least two years postmenopausal or using one of the following means of birth control: surgical sterility, double barrier methods, intraunterine contraceptive device, lifestyle with a personal choice of abstinence, vasectomy of sexual partner at least 3 months prior to enrolment in combination with barrier methods. It is assumed that contraception for male patients is not considered as medically important.
- Signed written informed consent to participate in the study

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

- Previous therapy with insulin 3 months prior to inclusion into the study
- Previous therapy with glitazones 6 months prior to inclusion into the study
- Changesin therapy with lipid-lowering or anti-hypertensive agents within one month prior to inclusion into the study (a stable lipid-lowering or anti-hyperensive therapy is allowed )
- Concomitant participation in other clinical trials
- Type 1 diabetes
- Cardiovascular disease :
o Clinically relevant ventricular tachycardia or ventricular fibrillation, 3rd degree AV block or Torsades de Pointes or treatment with antiarrhythmic drugs.
o Percutaneous coronary intervention within the past 6 months.
o Any of the following within the past 6 months:
myocardial infarction (MI) (If the visit 1 ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the subject can enter the study at the discretion of the investigator);
coronary artery bypass surgery;
unstable angina;
or stroke.
o Congestive heart failure NYHA class III or IV
- Malignancy including leukemia and lymphoma within the last 5 years
- Liver disease such as cirrhosis or chronic active hepatitis
- Significant renal dysfunction (see also exclusion criteria laboratory abnormalities)
- Endocrine disease:
o Acromegaly or treatment with growth hormone or similar drugs.
o Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks
o Thyroid hormone replacement is allowed if the dosage has been stable for at least 3 months and the TSH is within normal limits
- Any of the following significant laboratory abnormalities:
o Serum creatinine levels = 2.5 mg/dl (220 ?mol/l)
o Fasting triglycerides ?700 mg/dl (>7.9 mmol/l)
- History of active substance abuse (including alcohol > 40g/day and drugs) within the past 2 years
- Female patients: Pregnancy or childbearing potential without adequate contraception (for male patients contraception is not considered as medically important)
- Present therapy with systemic steroids
- Presence of psychiatric disorder or intake of anti-depressive or anti-psychotic agents with the exception of benzodiazepines and SSRIs/SNRI´s
- Use of anti-obesity drugs 3 months prior or during the trial
- Potentially unreliable subjects, and those judged by the investigator to be unsuitable for the study
- Persons who are not familiar with the insulin injection system
- Contraindications for MRI scanning such as persons with cardiac pacemaker and implants out of metal or claustrophobia
- Missing signed written informed consent to participate in the study
- Known hypersensitivity to insuline detemir, insulin glargine or to any of the other components (see SPC/”Fachinformation appendix 17.2. and 17.3.)

Study & Design

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