CompletedPhase 3

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

United States94 participantsStarted 2007-03-06

Plain-language summary

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.

Who can participate

Age range18 Years – 78 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

glycosylated hemoglobin (HbA1c)at Baseline and week 24

Timeframe: 24 weeks

Trial details

NCT IDNCT00468039

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-06-06

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials