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OpenTrials
Completed

NCT Number: NCT00616811

Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) < 30 mL/min) for a period of 24 weeks.

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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

University of South Alabama Medical Center, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • History T2 DM
  • Severe Renal Impairment

Exclusion criteria

  • Glucose ≥ 270 mg/dL (≥15 mmol/L)
  • Patients undergoing any method of dialysis
  • Treatment with therapy other than sulfonylureas, TZDs ,insulin, and metiglinides

Treatment and study plan

Vildagliptin

Drug

Sitagliptin

Drug

Primary outcomes

  1. Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment

    Time frame: 24 weeks

Secondary outcomes

  1. Relationship between renal function and concentration levels of vildagliptin and its metabolites after repeated doses of vildagliptin in patients with T2DM and severe renal insufficiency.

    Time frame: 24 weekd

  2. Efficacy of vildagliptin versus sitagliptin in patients with T2DM and severe renal insufficiency by assessing the hemoglobin A1c (HbA1c ) and fasting plasma glucose (FPG) reduction from baseline

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With Vildagliptin (50 mg qd) Versus Sitagliptin (25 mg qd) in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 15, 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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