NCT02343926

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 443 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study consists of 2 weeks screening and 24 weeks of treatment (a total of 26 weeks). The protocol includes a screening period of two weeks, after which they will be randomized to receive gemigliptin or vildagliptin. Patients will be evaluated through 4 mandatory visits during the study. Visit 1: Week -2 (screening) Visit 2: Week 0 (randomization) Visit 3: Week 12 (efficacy and safety evaluation) Visit 4: Week 24 (efficacy and safety evaluation)

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	GEMIGLIPTIN LS15-0444	Pharmaceutical form:tablet Route of administration: oral
DRUG	vildagliptin	Pharmaceutical form:tablet Route of administration: oral
DRUG	metformin	Pharmaceutical form:tablet Route of administration: oral

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-01-22
• Last updated: 2016-05-18

Locations

1 site across 1 country: Russia