A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: exenatide and placebo; Drug: Exenatide and placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00517283

H8O-EW-GWAM

Details and patient eligibility

About

As exenatide slows the rate at which materials leave the stomach, it is likely to alter the rate of intestinal absorption of oral drugs when administered within a certain timeframe relative to exenatide. In addition, the residence time within the stomach of other medication may be prolonged and data from this study will help assess the change in residence time in the presence of therapeutic doses of exenatide. This study will also evaluate the relationship between blood levels of exenatide and parameters measuring rate of stomach emptying.

Enrollment: 17 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with at least 1 year history of type 2 diabetes mellitus.
• Subjects controlled by oral antidiabetic agents or diet and exercise demonstrated by a screening HbA1c ≥7.0% and ≤10.0%.
• Between the body mass index (BMI) of 19 kg/m2 and 40 kg/m2, inclusive.

Exclusion criteria

• Within 4 months of the initial dose of study drug, have received a drug that has not received regulatory approval for any indication.
• Persons who have previously completed or withdrawn from this study or any other study investigating exenatide.
• Subjects who are using drugs that significantly affect gastrointestinal motility (including acarbose, metoclopramide, and macrolide antibiotics).
• Subjects who intend to start new concomitant medication during the study, including over-the counter medication, apart from occasional intake of paracetamol or vitamin/mineral supplements. Anti-emetic medication may be permitted at the investigator's discretion, except those that affect gastrointestinal motility.
• Subjects who have used insulin for more than 4 weeks within 3 months prior to screening.
• Blood donation of more than 500 mL in the last 3 months of screening or any blood donation within the last month.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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17 participants in 3 patient groups

Sequence 1

Experimental group

Description:

Exenatide 5 mcg - Exentatide 10 mcg - Placebo

Treatment:

Drug: exenatide and placebo

Sequence 2

Experimental group

Description:

Exenatide 10 mcg - Placebo - Exenatide 5 mcg

Treatment:

Drug: Exenatide and placebo

Drug: Exenatide and placebo

Sequence 3

Experimental group

Description:

Placebo - Exenatide 5 mcg - Exenatide 10 mcg

Treatment:

Drug: Exenatide and placebo

Drug: Exenatide and placebo