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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01196546
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : August 1, 2017
Information provided by (Responsible Party):

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vildagliptin/metformin Drug: vildagliptin/metformin

Primary Outcome Measures :
  1. HbA1c reduction [ Time Frame: 24 weeks after treatment ]

Secondary Outcome Measures :
  1. Proportion of patients who achieve target of HbA1c<6.5% at the end of study [ Time Frame: 24 weeks after treatment ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Responsible Party: Novartis Identifier: NCT01196546     History of Changes
Other Study ID Numbers: CLMF237ATH01
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Type 2 Diabetes Mellitus

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