NCT00765830

Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)

A 28 Week Extension to a 24 Week Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 349 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Diabetes Mellitus, Type 2
• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	vildagliptin	50mg qd
DRUG	Placebo	qd

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2008-10-03
• Last updated: 2020-12-17

Locations

90 sites across 12 countries: Argentina, Australia, Canada, Costa Rica, Finland, France, Germany, India, Norway, Russia, Spain, Sweden