Back to results

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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Vildagliptin

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes mellitus, vildagliptin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

vildagliptin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01356381

First Posted

May 17, 2011

Last Updated

August 29, 2013

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01356381

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

Diabetes mellitus, vildagliptin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vildagliptin

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Vildagliptin

Intervention Description

Dosage 50mg b.i.d.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

50mg bid

Primary Outcome Measure Information:

Title

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

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Newcastle Upon Tyne

ZIP/Postal Code

NE4 5PL

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

25664602

Citation

Macauley M, Hollingsworth KG, Smith FE, Thelwall PE, Al-Mrabeh A, Schweizer A, Foley JE, Taylor R. Effect of vildagliptin on hepatic steatosis. J Clin Endocrinol Metab. 2015 Apr;100(4):1578-85. doi: 10.1210/jc.2014-3794. Epub 2015 Feb 9.

Results Reference

derived

PubMed Identifier

25583442

Citation

Macauley M, Smith FE, Thelwall PE, Hollingsworth KG, Taylor R. Diurnal variation in skeletal muscle and liver glycogen in humans with normal health and Type 2 diabetes. Clin Sci (Lond). 2015 May 1;128(10):707-13. doi: 10.1042/CS20140681.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs