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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01196546
First received: August 28, 2010
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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

Locations
Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
BMA Medical College and Vajira Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Police General Hospital
Bangkok, Thailand
Phamongkutklao 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
Novartis
  More Information

No publications provided

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
vildagliptin
metformin

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

ClinicalTrials.gov processed this record on May 21, 2013