Study to Assess the Effect of 24 Weeks of Treatment With Vildagliptin in Patients With Type 2 Diabetes
This study is currently recruiting participants.
Verified April 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01356381
First received: May 17, 2011
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Vildagliptin Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Measure: effect of treatment on insulin sensitivity, assessed as glucose Rd (rate of glucose disposal). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 44 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: vildagliptin |
Drug: Vildagliptin
Dosage 50mg b.i.d.
|
| Experimental: Placebo |
Drug: Placebo
50mg bid
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 1.
- HbA1c ≤ 7.6% at Visit 1.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356381
Contacts
| Contact: Novartis Pharmaceuticals | +41613241111 | |
| Contact: Novartis Pharmaceuticals |
Locations
| United Kingdom | |
| Novartis Investigative Site | Recruiting |
| Newcastle Upon Tyne, United Kingdom, NE4 5PL | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01356381 History of Changes |
| Other Study ID Numbers: | CLAF237A2389, 2006-004400-40 |
| Study First Received: | May 17, 2011 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Food and Drug Administration UK: Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk) |
Keywords provided by Novartis:
|
Diabetes mellitus vildagliptin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vildagliptin Dipeptidyl-Peptidase IV Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013