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A Study to Assess the Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes

A Double-blind, Crossover, Placebo-Controlled, Multiple-dose Study to Evaluate the Effects of Vildagliptin on Gastric Emptying, Gastric Volume and Satiety in Patients With Type 2 Diabetes

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00351507
Enrollment
10
Registered
2006-07-13
Start date
2005-05-31
Completion date
2006-02-28
Last updated
2012-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Vildagliptin, Type 2 diabetes

Brief summary

This study was designed to directly assess the effects of vildagliptin on gastric emptying in people with type 2 diabetes.

Interventions

DRUGVildagliptin

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed with type 2 diabetes for at least 6 months * Blood glucose criteria must be met * BMI in the range 22-40

Exclusion criteria

* History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes * Use of thiazolidinediones or need for insulin within 3 months prior to screening * Significant concomitant diseases or complications of diabetes * High fasting triglycerides as defined by the protocol Other protocol-defined inclusion/

Design outcomes

Primary

MeasureTime frame
Effect on gastric emptying

Secondary

MeasureTime frame
Effect on gastric volume
Effect on satiety
Effect on endogenous glucose appearance, glucose appearance and glucose disposal

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026