Trial intelligence / Profile preview

Sitagliptin effects on gastric emptying in Type 2 Diabetes

NCT02324010Phase 2

Key facts

Status: Completed
Start: Jul 2015
Primary completion: Jan 2017
Countries: 1
Sponsor: Royal Adelaide Hospital
Modality: Small Molecules

Drugs: sitagliptin
Conditions: type 2 diabetes mellitus (T2DM)

Overview

Phase 2, randomised, double-blind trial in type 2 diabetes mellitus (T2DM) comparing Sitagliptin with Placebo (2 arms). Primary endpoint: Gastric emptying at 3 hours. Started Jul 2015; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Sitagliptin
Sitagliptin 100mg daily for 2 days
Placebo
Matching placebo daily for 2 days

Who it enrols

Patients with Type 2 diabetes managed by diet or metformin alone, BMI 20-40 kg/m2, and HbA1c <= 8.5%. Excludes patients with GI disease, significant illness, or impaired renal/liver function.

Endpoints

Primary

Gastric emptying3 hours

Secondary

Postprandial Glycaemia4 hours
Gastrointestinal hormone release4 hours
Intragastric meal distribution3 hours
Blood pressure4.5 hours
Heart rate4.5 hours
Splanchnic blood flow4 hours
Cardiac output4 hours
Stroke volume4 hours

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