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NCT Number: NCT00468039

A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin

This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose.

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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

Diabetes and Glandular Disease Research Associates

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
  • Diagnosis of type 2 diabetes for at least 4 weeks prior to study entry
  • Body mass index 22-40 kg/meter squared
  • HbA1c > 11% and/or FPG >270 mg/dL

Exclusion criteria

  • Pregnant or lactating female
  • History of type 1 diabetes
  • Evidence of significant diabetic complications
  • Treatment with insulin or any other oral antidiabetic agent

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

vildagliptin + metformin

Drug

Primary outcomes

  1. glycosylated hemoglobin (HbA1c)at Baseline and week 24

    Time frame: 24 weeks

Secondary outcomes

  1. HbA1c at Baseline and week 12

    Time frame: 12 weeks

  2. Fasting plasma glucose test (FPG) at Baseline and week 24

    Time frame: 24 weeks

  3. Weight at baseline and week 24

    Time frame: 24 weeks

  4. Responder rates assessed by HbA1c absolute reduction from baseline to endpoint greater than or equal to 0.7% after 24 weeks

    Time frame: 24 weeks

  5. Safety assessed by monitoring and recording all adverse events, serious adverse events.

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Multicenter, Open-label Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin 100mg qd Plus Metformin 1000mg Bid in Drug Naive Patients With Type 2 Diabetes With Very Poor Glycemic Control

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 1, 2007
Registry last updated
Dec 19, 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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