Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

A 12 Week Multi Center, Open Label, Single Arm Study to Assess the Safety and Efficacy of Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01426802

Enrollment

150

Registered

2011-08-31

Start date

2010-10-31

Completion date

2011-04-30

Last updated

2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

metformin, vildagliptin, T2DM

Brief summary

The study is designed to demonstrate the short term efficacy and safety of vildagliptin 50 mg bid in patients with Type 2 Diabetes Mellitus inadequately controlled with Metformin.

Interventions

DRUGvildagliptin

Drug 50mg vildagliptin bid

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients who sign the informed consent * HbA1c in the range of \> 7 to ≤10.5% at Visit 1 * Ability to comply with all study requirements

Exclusion criteria

* Pregnant or lactating women * Serious cardiovascular disorders * Liver/renal disease or dysfunction * Anti-diabetic other than metformin, thiazolidine, or α-GI or insulin * Laboratories values abnormalities as defined by the protocol

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the safety and tolerability of vildagliptin 50 mg bid	12 weeks	Efficacy of vildagliptin based on the reduction in mean HbA1c and mean fasting plasma glucose with vildagliptin treatment at 12 weeks. Safety is measured by monitoring lipids profile, liver and kidney function to assess vildagliptin safety.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026