Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone

A Multicenter, Double-blind, Randomized Parallel-group, Study to Demonstrate the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd as add-on to Metformin 500 mg Bid Compared to Metformin 1000 mg Bid in Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00396357

Enrollment

914

Registered

2006-11-06

Start date

2006-10-31

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, hemoglobin A1c, metformin

Brief summary

This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.

Interventions

DRUGVildagliptin

DRUGmetformin

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

* 18-78 years inclusive * Type 2 diabetes diagnosis at least 2 months prior to study entry * Body mass index in the range of 22-45 kg/m2 * HbA1c in the range of 6.5 to 9% inclusive * Fasting plasma glucose \<270 mg/dL (15 mmol/L)

Exclusion criteria

* A history of type 1 diabetes * Evidence of significant diabetic complications * Treatment with insulin or any other oral antidiabetic agents * Congestive heart failure requiring pharmacologic treatment * Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels \>/= 1.5 mg/dl (males) and \>/= 1.4 mg/dl (females) Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment	24 weeks

Secondary

Measure	Time frame
Adverse event profile after 24 weeks of treatment	24 weeks
Gastrointestinal tolerability after 24 weeks of treatment	24 weeks
Patients with endpoint HbA1c <7% and <6.5% after 24 weeks	24 weeks
Patients with reduction in HbA1c >0.7% after 24 weeks	24 weeks
Change from baseline in fasting plasma glucose after 24 weeks	24 weeks

Countries

Germany, United States

Outcome results

None listed

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