Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Metformin; Drug: Insulin glargine

• Registration Number: NCT00857870
• Lead Sponsor: GWT-TUD GmbH

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 and metformin has not been evaluated in patients with type 2 diabetes and HbA1C greater or equal 7 % and lower than 8.1%.Besides HbA1C postprandial glucose excursion and glycemic variability as determinants of oxidative stress will be measured by continuous glucose measurement(CGM). Further more CGM will reveal risk of hypoglycemia at night. As secondary objectives effect on endothelial function, renal function and biomarkers of low great inflammation will be evaluated. So far only scarce information on face to face comparison in ealy diabetes exists.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-06
• Study First Submitted QC: 2009-03-06
• Study First Posted: 2009-03-09
• Primary Completion: 2011-08
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-10
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	-
Insulin glargine	Insulin glargine	-

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) after a testmeal measured CGM.	baseline and visit 8

Secondary Outcome Measures

Name	Time	Method
HbA1C, glycemic variability, glycemic load, insulin secretion after testmeal, free fatty acids, biomarkers of low grade inflammation, endothelial dysfunction.	baseline and visit 8

Trial Locations

Locations (1)

GWT -TUD, Center for Clinical Studies; 🇩🇪 Dresden, Germany