Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM)
Multi-center, Open-label, 24-week Study to Demonstrate the Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin 50/500 or 50/1000 mg Twice Daily in Patients With T2DM Inadequately Controlled With Metformin
1 other identifier
interventional
161
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 type-2-diabetes-mellitus
Started Mar 2010
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 28, 2010
CompletedFirst Posted
Study publicly available on registry
September 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedAugust 1, 2017
February 1, 2017
1.6 years
August 28, 2010
July 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c reduction
24 weeks after treatment
Secondary Outcomes (2)
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
Study Arms (1)
Vildagliptin/metformin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (8)
BMA Medical College and Vajira Hospital
Bangkok, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Phamongkutklao Hospital
Bangkok, Thailand
Police General Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Khon Kaen Hospital
Khon Kaen, Thailand
Fort Suranaree Hospital
Nakhon Ratchasima, Thailand
Maharat Nakhon Ratchasima Hospital
Nakhon Ratchasima, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2010
First Posted
September 8, 2010
Study Start
March 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
August 1, 2017
Record last verified: 2017-02