Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone

A Multi-center, Randomized, Open-label, Active Controlled, Parallel Arm Study to Compare the Efficacy of 12 Weeks of Treatment With Vildagliptin 100 mg, qd to Thiazolidinedione (TZD) as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy in a Community-based Practice Setting.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00396227

Enrollment

2665

Registered

2006-11-06

Start date

2006-10-31

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, metformin

Brief summary

This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.

Interventions

DRUGvildagliptin

vildagliptin as add-on to metformin

DRUGthiazolidinedione (TZD)

TZD add-on to metformin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Inclusion criteria

* Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2) * Agreement to maintain the same dose of metformin from screening to the end of the study * Age in the range of 18-80 years * Body mass index (BMI) in the range of 22-40 kg/m2 * HbA1c in the range of 7.0 to 10% * FPG \<270 mg/dL (15 mmol/L)

Exclusion criteria

* A history of type 1 diabetes * Liver disease * Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1 Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Change from baseline in HemoglobinA1c (HbA1c)	after 12 weeks of treatment

Secondary

Measure	Time frame
Change from baseline in body weight	after 12 weeks of treatment
Change from baseline in fasting plasma glucose (FPG)	after 12 weeks of treatment
Incidence of prespecified adverse events while on treatment with study drug	12 week treatment duration

Countries

United States

Outcome results

None listed

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