OPEN-LABEL, RANDOMIZED STUDY TO ASSESS THE SAFETY AS WELL AS THE PHARMACOKINETIC PROFILE AND TO INVESTIGATE THE EFFICACY TRENDS ON BIOMARKERS IN TYPE 2 DIABETES MELLITUS PATIENTS OF A SUSTAINED RELEASE FORMULATION OF EXENATIDE BASED ON MEDUSA* TECHNOLOGY

Completed

• Conditions: Diabetes Mellitus Type 2; 10018424

• Registration Number: NL-OMON44056
• Lead Sponsor: FLAMEL TECHNOLOGIES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

Part A;
Gender: healthy male or female
Age: 18 - 65 years, inclusive
Body Mass Index: >22.0 - <35.0 kg/m2 ;Part B:
Gender: male or female T2DM patients
Age: 18 - 75 years, inclusive
Body Mass Index: >25.0 - <40.0 kg/m2

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, 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. In case of donating more than 1.5 liters 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>To assess the safety and tolerability of Exenatide MPF *Sustained Release*<br /><br>formulation following two subsequent rising doses in healthy volunteers versus<br /><br>a reference treatment in healthy volunteers<br /><br>To assess the safety and tolerability of a repeated dosing regimen of Exenatide<br /><br>MPF *Sustained Release* formulation in type 2 diabetes mellitus (T2DM) patients</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the pharmacokinetic (PK) profile and PK parameters variability of<br /><br>Exenatide MPF *Sustained Release* formulation following two sequential dose<br /><br>escalations in healthy volunteers versus a reference treatment in healthy<br /><br>volunteers<br /><br>To investigate the effect of Exenatide MPF *Sustained Release* formulation<br /><br>following a 4 week repeated dosing regimen on selected biomarkers and surrogate<br /><br>endpoints in T2DM patients<br /><br>To assess the PK profile and PK parameters variability of Exenatide MPF<br /><br>*Sustained Release* formulation following a repeated dosing regimen in T2DM<br /><br>patients</p><br>