Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Vildagliptin

• Registration Number: NCT01233622
• Lead Sponsor: Novartis

Brief Summary

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-03
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (metformin + glimepiride)	Placebo	-
Vildagliptin (metformin + glimepiride)	Vildagliptin	-

Primary Outcome Measures

Name	Time	Method
HbA1c Reduction	24 weeks

Secondary Outcome Measures

Name	Time	Method
FPG reduction	24 weeks
Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs)	24 weeks
Responder Rate	24 weeks

Trial Locations

Locations (6)

Novartis Investigative Site; 🇨🇳 Yongkang, Taiwan

Novartis Investigative Site #3; 🇲🇽 Pachuca, Mexico

Novartis Investigative Site #5; 🇲🇽 Guadalajara, Mexico

Novartis Investigative Site #4; 🇲🇽 Guadalajara, Mexico

Novartis Investigative Site #2; 🇷🇴 Oradea, Romania

Novartis Investigative Site #1; 🇷🇴 Oradea, Romania