Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)

A 28-week Extension to a 24-week Multicenter, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Sitagliptin (25 mg qd) in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00770081

Enrollment

Registered

2008-10-09

Start date

2008-09-30

Completion date

2011-04-30

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, Renal Insufficiency

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)) 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 52 weeks.

Interventions

DRUGvildagliptin

50mg qd

DRUGsitagliptin

25mg qd

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

* Complete the core study and consent for extension

Exclusion criteria

* Patient unable to comply with core study requirements

Design outcomes

Primary

Measure	Time frame
Assessment of treatment emergent adverse events (including hypoglycemia events and other events of special interest)	52 weeks

Secondary

Measure	Time frame
To assess hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reduction from baseline after 52 weeks of treatment	52 weeks

Countries

United States

Outcome results

None listed

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