Who is sponsoring NCT02343926?

NCT02343926 is sponsored by Sanofi.

What condition does NCT02343926 study?

NCT02343926 studies Type 2 Diabetes Mellitus.

What drugs are being tested in NCT02343926?

Interventions: GEMIGLIPTIN LS15-0444, vildagliptin, metformin.

What is the status of NCT02343926?

NCT02343926 is currently COMPLETED.

Last reviewed 2016-05-17 · How we verify

A Multicentre, National, Randomized, Parallel-group, Phase 3 Study to Compare the Efficacy and Safety of Gemigliptin and Vildagliptin as Add-on Therapy to Metformin in People With Type 2 Diabetes Inadequately Controlled With Metformin

NCT02343926 Phase 3 COMPLETED

Primary Objective: To compare the clinical efficacy of gemigliptin and vildagliptin as add-on therapy to metformin in terms of change in Hemoglobin A1c (HbA1c) reduction. Secondary Objectives: To compare the safety and tolerability of gemigliptin and vildagliptin: * Number of patients who experience at least one episode of hypoglycemia. * Number of patients experiencing adverse event (AE), serious adverse event (SAE). * Assessment of patients compliance defined as number tablets returned by patients.

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	443
Start date	2014-12
Completion	2016-04

Conditions

Type 2 Diabetes Mellitus

Interventions

GEMIGLIPTIN LS15-0444
vildagliptin
metformin

Primary outcomes

Change from baseline in HbA1c — Up to Week 24

Countries

Russia