A Multicenter, Randomized, Active-controlled, Parallel Group, Open-label, Exploratory Study to Evaluate the Efficacy on Glucose Variability(MAGE, Glucose SD) and Safety of Initial Combination Therapy of Gemigliptin 50mg q.d., Versus Sitagliptin 100mg q.d., or Glimepiride 2mg q.d. With Metformin 500-1,000mg q.d. in Patients With Type 2 Diabetes (STABLE)

NCT01890629 Phase 4 COMPLETED

To compare efficacy and safety of initial combination therapy of Gemigliptin versus Sitagliptin or Glimepiride with Metformin on Glucose Variability(MAGE, Glucose SD) in Patients With Type 2 Diabetes Mellitus.

Details

Lead sponsor	LG Life Sciences
Phase	Phase 4
Status	COMPLETED
Enrolment	69
Start date	2013-05
Completion	2014-08

Conditions

• Type 2 Diabetes Mellitus

Interventions

• Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin

Primary outcomes

• Mean Amplitude Glycemic Excursion — Change of MAGE at Week 12 from baseline

Countries

South Korea