Impact of exercise training and insulin treatment in patients with type 2 diabetes treated with metformi

• Conditions: Type 2 diabetes; MedDRA version: 8.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2006-003269-15-SE
• Lead Sponsor: Karolinska University hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.Type 2 diabetes according to clinical judgment.
3.Duration of type 2 diabetes = 12 months since diagnosis.
4.C-peptide ?0.4 nmol/L
5.Insulin naïve. Short term insulin treatment (7 days or less within the last 6 months) is allowed.
6.Oral anti-diabetic treatment for at least 4 months.
7.Age ? 35 and ?65 years, female or male.
8.BMI ? 35 kg/m2.
9.HbA1c =7.0% at screening and based on analysis from the central laboratory are eligible for the study.
10.Able and willing to adhere to the trial-specific insulin/OAD/exercise regimen for the entire trial period.
11.Able and willing to perform self-monitoring of blood glucose according to the protocol.
12.Able and willing to perform tests and examinations specified in the protocol.

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous participation in this trial. Participation is defined as randomisation.
2.Receipt of any investigational drug within 4 weeks prior to this trial.
3.Anticipated change in dose of concomitant medication which may interfere with glucose metabolism, such as systemic corticosteroids, non-selective beta-blockers, mono amine oxidase (MAO) inhibitors and anabolic steroids.
4.Proliferative retinopathy or maculopathy that requires acute treatment or has had laser treatment within the last 6 months.
5.Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator.
6.Impaired hepatic function measured as alanine aminotransferase (ALAT) ? three times the upper reference limit based on analysis from the central laboratory.
7.Impaired renal function measured as S-creatinine ?130 µmil/L
8. Cardiac disease defined as :
a.Unstable angina pectoris
b.Myocardial infarction (MI) within the last 6 months
c.Congestive heart failure NYHA class III and IV
9.Uncontrolled treated/untreated hypertension (systolic blood pressure ?180 mmHg and/or diastolic blood pressure ? 105mmHg).
10.Chronic foot ulcer.
11.Proliferative retinopathy.
12.Physical limitations which do not allow the patient to participate in an exercise training program.
13.Uncontrolled thyroid disorder.
14.Known or suspected allergy to trial product or related products.
15.Malignancy.
16.Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation.
17.Any other condition that the Investigator and/or Sponsor feel would interfere with trial participation or evaluation of results.
18.GAD positive.
19.Tiazolidindione therapy within 6 months prior to trial.

Study & Design

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