Study to Assess the Effect of 24 Weeks of Treatment With Vildagliptin in Patients With Type 2 Diabetes

A Single-center,Double-blind,Randomised,Placebo-controlled,Parallel-group Study to Assess the Effect of 24 Weeks of Treatment With Vildagliptin on Insulin Sensitivity and Its Underlying Mechanism in Patients With T2DM Treated With Metformin

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01356381

Enrollment

Registered

2011-05-19

Start date

2011-04-30

Completion date

2013-08-31

Last updated

2013-08-30

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

Diabetes mellitus, vildagliptin

Brief summary

The study will demonstrate the effect of 24 weeks of treatment with vildagliptin compared to placebo on insulin sensitivity in patients with type 2 diabetes mellitus (T2DM) treated with metformin, assessed as glucose Rd (rate of glucose disposal) during a hyperinsulinemic euglycemic clamp.

Interventions

DRUGVildagliptin

Dosage 50mg b.i.d.

DRUGPlacebo

50mg bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Age in the range of 18-70 years. 2. Patients with T2DM, diagnosed at least 6 months prior to Visit 1, who have received metformin for at least 3 months and have been on a stable dose of at least 1000mg daily for a minimum of 4 weeks prior to Visit 1. 3. HbA1c ≤ 7.6% at Visit 1. 4. Body mass index (BMI) in the range of 22-38kg/m2 inclusive at Visit 1.

Exclusion criteria

1. Pregnant or nursing (lactating) women. 2. Patients with cardiac pacemakers or with metallic implants incompatible with magnetic resonance methodology. 3. Congestive heart failure requiring pharmacologic treatment. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Measure: effect of treatment on insulin sensitivity, assessed as glucose Rd (rate of glucose disposal).	24 weeks

Countries

United Kingdom

Outcome results

None listed

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