drugset / Trial / NCT00857870

Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects

NCT00857870 ↗

Phase 4 Completed 96 enrolled GWT-TUD GmbH
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-03
Primary completion
2011-08
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 1000 mg Oral
Comparator insulin glargine Protein / enzyme biologic — Subcutaneous