Open Label Single Period Pilot Clinical Trial to Standardize Procedures for Evaluation of Glucose Dependent Insulin Secretion in Subjects with Type 2 Diabetes Mellitus

Completed

• Conditions: Diabetes; 10018424; insulin secretion

• Registration Number: NL-OMON36208
• Lead Sponsor: PRA International EDS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

Male, 18-55 years, inclusive
BMI is less than or equal to 38.0 kg/m2
Type 2 Diabetes Mellitus Patient

Exclusion Criteria

Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study or in case of donating more than 1.5 liter of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Standardizing the methodology<br /><br><br /><br>Pharmacodynamics<br /><br>Pharmacokinetics<br /><br>Safety</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>