Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects (GLORY)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparative Investigation of Efficacy and Safety of Insulin Glargine Versus Metformin as First Line Drug in Treatment of Early Type 2 Diabetes|
- Area under the curve (AUC) after a testmeal measured CGM. [ Time Frame: baseline and visit 8 ] [ Designated as safety issue: No ]
- HbA1C, glycemic variability, glycemic load, insulin secretion after testmeal, free fatty acids, biomarkers of low grade inflammation, endothelial dysfunction. [ Time Frame: baseline and visit 8 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Metformin||
Metformin is administered as coated tablet. Initial dose is 500 mg twice a day (morning and evening) during or after the meal. The first administration takes place on the evening of visit 1c. The duration of the therapy is 36 weeks until visit 8c.
Initial dose of 500 mg bid was increased after 4 weeks (visit 2) to 850 mg bid when the patient tolerated the initial dose. If the side effects were not tolerable, the initial dose was decreased to 500 mg once a day and where appropriate increased at a later visit.
After 8 weeks (visit 3) metformin dose was increased to 1000 mg bid when tolerated. If dose is not tolerated, it was decreased to the next lower dose.
|Active Comparator: Insulin glargine||
Drug: Insulin glargine
Insulin glargine is given subcutaneously with an insulin-pen (SoloStar®). The dose was titrated to reach a fasting plasma glucose value of <5.6 mmol/l. Insulin glargine was given once a day in the evening before going to bed (bed-time injection). The first insulin injection takes place on the evening of visit 1c. The duration of the therapy is 36 weeks until visit 8c. All patients were trained in handling and storage of the insulin-pen.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857870
|GWT -TUD, Center for Clinical Studies|
|Dresden, Germany, 01307|