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A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

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Novartis

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Vildagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00300287
CLAF237A2307E1

Details and patient eligibility

About

This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Completion of study CLAF237A2307 within 4 weeks of entering into the extension
  • Written informed consent
  • Ability to comply with all study requirements
  • Blood glucose criteria must be met

Exclusion criteria

  • Premature discontinuation from study CLAF237A2307

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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