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OpenTrials
Completed

NCT Number: NCT00646542

Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency.

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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–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • History T2DM
  • Moderate or Severe Renal Impairment

Exclusion criteria

  • Glucose > 270 mg/dL (>15 mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Vildagliptin

Drug

Other names: Galvus

Placebo

Drug

Primary outcomes

  1. To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment

    Time frame: 24 weeks

Secondary outcomes

  1. To assess concentration levels of vildagliptin and its metabolites in patients with T2DM and moderate or severe renal insufficiency.

    Time frame: 24 weeks

  2. To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency.

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

Important dates

Study start
2005
Primary completion
2010
First posted
Mar 28, 2008
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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