drugset / Trial / NCT01267448

Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia

NCT01267448

Phase 4 Completed 100 enrolled Cook County Health Bristol-Myers Squibb · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Saxagliptin + Metformin XR (S+M) will be effective in stabilizing blood glucose (BG) levels in patients with newly diagnosed type 2 diabetes (T2DM) with severe hyperglycemia (BG levels 300 to 450 mg/dl) and glucose toxicity and with no criteria for inpatient admission or occurrence of severe hypoglycemia compared to glipizide XL. The study may provide preliminary evidence to support the role of S+M as a bridging, stabilizing and safe therapy in patients with severe hyperglycemia

Timeline

Start
2014-09-09
Primary completion
2015-07-25
Completion
2015-07-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glipizide Small molecule 10 mg Oral
Comparator Metformin Small molecule 2000 mg
Comparator SAXAGLIPTIN ANHYDROUS Small molecule 5 mg