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
2 other identifiers
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 type-2-diabetes-mellitus
Started Apr 2011
Typical duration for phase_4 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 17, 2011
CompletedFirst Posted
Study publicly available on registry
May 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedAugust 30, 2013
August 1, 2013
2.3 years
May 17, 2011
August 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure: effect of treatment on insulin sensitivity, assessed as glucose Rd (rate of glucose disposal).
24 weeks
Study Arms (2)
vildagliptin
EXPERIMENTALPlacebo
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pregnant or nursing (lactating) women.
- Patients with cardiac pacemakers or with metallic implants incompatible with magnetic resonance methodology.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Investigative Site
Newcastle upon Tyne, NE4 5PL, United Kingdom
Related Publications (2)
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.
PMID: 25664602DERIVEDMacauley 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.
PMID: 25583442DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2011
First Posted
May 19, 2011
Study Start
April 1, 2011
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
August 30, 2013
Record last verified: 2013-08