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OpenTrials
Completed

NCT Number: NCT00396357

Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone

This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus 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 3

Primary location

Novartis Investigative Site, Multiple Locations, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-78 years inclusive
  • Type 2 diabetes diagnosis at least 2 months prior to study entry
  • Body mass index in the range of 22-45 kg/m2
  • HbA1c in the range of 6.5 to 9% inclusive
  • Fasting plasma glucose <270 mg/dL (15 mmol/L)

Exclusion criteria

  • A history of type 1 diabetes
  • Evidence of significant diabetic complications
  • Treatment with insulin or any other oral antidiabetic agents
  • Congestive heart failure requiring pharmacologic treatment
  • Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels >/= 1.5 mg/dl (males) and >/= 1.4 mg/dl (females)

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

metformin

Drug

Primary outcomes

  1. Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment

    Time frame: 24 weeks

Secondary outcomes

  1. Adverse event profile after 24 weeks of treatment

    Time frame: 24 weeks

  2. Gastrointestinal tolerability after 24 weeks of treatment

    Time frame: 24 weeks

  3. Patients with endpoint HbA1c <7% and <6.5% after 24 weeks

    Time frame: 24 weeks

  4. Patients with reduction in HbA1c >0.7% after 24 weeks

    Time frame: 24 weeks

  5. Change from baseline in fasting plasma glucose after 24 weeks

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized Parallel-group, Study to Demonstrate the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd as add-on to Metformin 500 mg Bid Compared to Metformin 1000 mg Bid in Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy

Important dates

Study start
2006
Primary completion
2008
First posted
Nov 6, 2006
Registry last updated
Dec 17, 2020

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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