Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects (GLORY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00857870|
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : January 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Metformin Drug: Insulin glargine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Investigation of Efficacy and Safety of Insulin Glargine Versus Metformin as First Line Drug in Treatment of Early Type 2 Diabetes|
|Study Start Date :||March 2009|
|Primary Completion Date :||August 2011|
|Study Completion Date :||December 2011|
|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.
- Area under the curve (AUC) after a testmeal measured CGM. [ Time Frame: baseline and visit 8 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857870
|GWT -TUD, Center for Clinical Studies|
|Dresden, Germany, 01307|