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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 443

Last updated 2016-05-18

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02343926 on ClinicalTrials.gov