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NCT Number: NCT01196546

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

BMA Medical College and Vajira Hospital, Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vildagliptin/metformin

Drug

Primary outcomes

  1. HbA1c reduction

    Time frame: 24 weeks after treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 8, 2010
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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