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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: August 28, 2010
Last updated: May 3, 2012
Last verified: May 2012
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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: vildagliptin/metformin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • HbA1c reduction [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients who achieve target of HbA1c<6.5% at the end of study [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: Yes ]

Enrollment: 161
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin/metformin Drug: vildagliptin/metformin


Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196546

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
Sponsors and Collaborators
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01196546     History of Changes
Other Study ID Numbers: CLMF237ATH01 
Study First Received: August 28, 2010
Last Updated: May 3, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Novartis:
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on May 24, 2016