Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes

A Multicenter, Double-blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 MG QD to Placebo as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00351884

Enrollment

370

Registered

2006-07-13

Start date

2006-05-31

Completion date

Unknown

Last updated

2016-11-18

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, Hemoglobin A1c

Brief summary

Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.

Interventions

DRUGVildagliptin AM

DRUGvildagliptin pm

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 78 Years

Healthy volunteers

Inclusion criteria

* Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1 * Body mass index in the range 22-40 * Blood glucose criteria must be met

Exclusion criteria

* Pregnancy or lactation * History of type 1 diabetes * Evidence of significant diabetic complications Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Change from baseline in HbA1c at 24 weeks	24 weeks

Secondary

Measure	Time frame
Safety of vildagliptin in combination with metformin during 24 weeks of treatment	24 weeks
Change from baseline in fasting plasma glucose at 24 weeks	24 weeks
Patients with endpoint HbA1c < 7% after 24 weeks	24 weeks
Patients with reduction in HbA1c greater than or equal to 0.7% after 24 weeks	24 weeks
Change from baseline in body weight at 24 weeks	24 weeks

Countries

Germany, United States

Outcome results

None listed

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