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CompletedNCT00351546Updated May 7, 2012

A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes

A Phase 3 interventional study of Vildagliptin in Diabetes Mellitus, Type 2, sponsored by Novartis. Completed. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-05-07.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study summary

Type 2 diabetes results when the body does not produce enough insulin and/or is unable to properly use the insulin it makes (insulin resistance). This study was undertaken to assess the effects of vildagliptin on insulin sensitivity in people with type 2 diabetes.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Vildagliptin
  • Type 2 diabetes
  • Insulin sensitivity
  • Insulin action
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 12 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with type 2 diabetes at least 3 months prior to screening
  • Blood glucose criteria must be met
  • On stable dose of metformin therapy
  • BMI less than or equal to 39

Exclusion criteria

Exclusion Criteria:

  • Type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes
  • Treatment with thiazolidinediones or use of insulin within the previous 3 months
  • Significant illness within 2 weeks prior to dosing
  • High fasting triglycerides as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
12 participants (actual)

Interventions

  • DrugVildagliptin
06

What researchers measure

Primary outcomes

  1. Effect on insulin sensitivity at 6 weeks

Secondary outcomes

  1. Lipolysis rate after 6 weeks of treatment

  2. Plasma free fatty acid concentration after 6 weeks of treatment

  3. Hepatic glucose production after 6 weeks of treatment

  4. Glucose disposal after 6 weeks of treatment

  5. Gluconeogenesis rate after 6 weeks of treatment

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00351546
Lead sponsor
Novartis
First posted
Jul 13, 2006
Start date
Feb 2005
Primary completion
Nov 2005
Completion
Dec 2005
Last update
May 7, 2012

Study contacts

David Kelley, MD
principal investigator · University of Pittsburgh
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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