Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM)

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: vildagliptin/metformin

• Registration Number: NCT01196546
• Lead Sponsor: Novartis

Brief Summary

This study will assess the efficacy and safety of combination therapy of vildagliptin/metformin in patients with T2DM inadequately controlled with metformin 1,000 mg/day.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-08-28
• Study First Submitted QC: 2010-09-04
• Study First Posted: 2010-09-08
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-07-30
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• Type 2 Diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months
• The patient is required to have HbA1c 6.5-11.0%
• BMI in the range of 22-48 kg/m2

Exclusion Criteria

• Severe or uncontrolled Type 2 diabetes mellitus (HbA1c> 11.0%)
• Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
• Congestive heart failure requiring pharmacologic treatment
• Any of following within past 6 months: (1) myocardial infarction; (2) unstable angina (3) coronary artery bypass surgery or percutaneous coronary intervention
• Liver disease such as cirrhosis or chronic active hepatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vildagliptin/metformin	vildagliptin/metformin	-

Primary Outcome Measures

Name	Time	Method
HbA1c reduction	24 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who achieve target of HbA1c<6.5% at the end of study	24 weeks after treatment
To evaluate the effect of combination therapy of vildagliptin (50 mg) plus metformin (500 or 1000 mg) twice daily on FPG and BMI, safety and tolerability profiles	24 weeks after treatment

Trial Locations

Locations (8)

Phamongkutklao Hospital; 🇹🇭 Bangkok, Thailand

Siriraj Hospital; 🇹🇭 Bangkok, Thailand

Fort Suranaree Hospital; 🇹🇭 Nakhon Ratchasima, Thailand

Police General Hospital; 🇹🇭 Bangkok, Thailand

BMA Medical College and Vajira Hospital; 🇹🇭 Bangkok, Thailand

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

Khon Kaen Hospital; 🇹🇭 Khon Kaen, Thailand

Maharat Nakhon Ratchasima Hospital; 🇹🇭 Nakhon Ratchasima, Thailand