Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes

A Multicenter, Randomized, Double-Blind, Active Controlled Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd or Metformin 1500 mg Daily in Elderly Drug Naive Patients With Type 2 Diabetes

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00383578

Enrollment

335

Registered

2006-10-03

Start date

2006-09-30

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 demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes

Interventions

DRUGVildagliptin 100 mg qd

DRUGMetformin 1500 mg daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age from 65 years to the upper age limit recommended by local prescribing information for metformin * Drug naive patients with type 2 diabetes. * Body mass index (BMI) in the range of 22-40 kg/m2. * HbA1c in the range of 7 to 9% inclusive * FPG \<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 Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Change from baseline in HbA1c	after 24 weeks of treatment

Secondary

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

Countries

Germany, Switzerland

Outcome results

None listed

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