Status:
COMPLETED
Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects
Lead Sponsor:
GWT-TUD GmbH
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
Brief Summary
Comparison of efficacy and safety of glargine insulin and metformin as first line drug of patients insufficiently treated with lifestyle intervention. So far treatment also algorithm with lifestyle an...
Eligibility Criteria
Inclusion
- early type 2 diabetes (lower than 5 years known)
- male and female(35 to 75 years)
- HbA1c 7 to 8 %, if drug naive and \<= 8.5 with previous OAD intake
- Informed consent
Exclusion
- any treatment more than one OAD at the same time
- treatment with one OAD \< 6 weeks time
- insulin treatment
- acute coronary syndrome \< 6 months
- severe liver disease
- alcohol abuse or drug addiction
- severe kidney disease
- acute critical illness with renal impairment
- i.v. application of iodine
- ketoacidosis
- acute or chronic illness witch may lead to hypoxia or cardial failure
- allergy against one of the drugs
- deficit in compliance or cooperation
- pregnancy or breast feeding
- women in fertile age without accepted contraceptive
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00857870
Start Date
March 1 2009
End Date
December 1 2011
Last Update
January 11 2012
Active Locations (1)
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1
GWT -TUD, Center for Clinical Studies
Dresden, Germany, 01307