NCT01356381CompletedPhase 4
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Measure: effect of treatment on insulin sensitivity, assessed as glucose Rd (rate of glucose disposal).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age in the range of 18-70 years.
- •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
- •HbA1c ≤ 7.6% at Visit
- •Body mass index (BMI) in the range of 22-38kg/m2 inclusive at Visit 1.
Exclusion Criteria
- •Pregnant or nursing (lactating) women.
- •Patients with cardiac pacemakers or with metallic implants incompatible with magnetic resonance methodology.
- •Congestive heart failure requiring pharmacologic treatment. Other protocol-defined inclusion/exclusion criteria may apply.
Arms & Interventions
vildagliptin
Experimental
Intervention: Vildagliptin (Drug)
Placebo
Experimental
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Measure: effect of treatment on insulin sensitivity, assessed as glucose Rd (rate of glucose disposal).
Time Frame: 24 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Safety, Tolerability, Effect of Vildagliptin and How the Body Changes the Blood Level of Vildagliptin in Healthy Chinese VolunteersHealthyNCT00419887Novartis60
Completed
Phase 3
Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin With or Without Metformin, in Patients With Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT01582230Novartis Pharmaceuticals293
Completed
Phase 3
Efficacy and Safety of Vildagliptin Versus Placebo in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00390520Novartis28
Completed
Phase 4
Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).Pulmonary Disease, Chronic ObstructiveNCT00523991Boehringer Ingelheim457
Completed
Phase 4
Safety and Efficacy Study to Compare Vildagliptin to Pioglitazone as Adding on Metformin in Type 2 DiabetesType 2 DiabetesNCT01882907Pusan National University Hospital287