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NCT01356381 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01356381
Other study ID # CLAF237A2389
Secondary ID 2006-004400-40
Status Completed
Phase Phase 4
First received May 17, 2011
Last updated August 29, 2013
Start date April 2011
Est. completion date August 2013

Study information
Verified date August 2013
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUK: Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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/exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vildagliptin
Dosage 50mg b.i.d.
• Placebo
50mg bid

Locations
Country Name City State
United Kingdom Novartis Investigative Site Newcastle Upon Tyne

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure: effect of treatment on insulin sensitivity, assessed as glucose Rd (rate of glucose disposal). 24 weeks No
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