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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00646542

Enrollment

525

Registered

2008-03-28

Start date

2005-03-31

Completion date

Unknown

Last updated

2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes, vildagliptin

Brief 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.

Interventions

DRUGVildagliptin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* History T2DM * Moderate or Severe Renal Impairment

Exclusion criteria

* Glucose \> 270 mg/dL (\>15 mmol/L) Other protocol-defined inclusion/

Design outcomes

Primary

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

Secondary

Measure	Time frame
To assess concentration levels of vildagliptin and its metabolites in patients with T2DM and moderate or severe renal insufficiency.	24 weeks
To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency.	24 weeks

Countries

Argentina, Australia, Canada, Costa Rica, Finland, France, Germany, India, Norway, Russia, Spain, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026