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

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 - Exenatide MPF SAD and MAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44056

Enrollment

Registered

2015-07-08

Start date

2015-07-15

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Diabetes Mellitus Type 2

Interventions

Part A of the study will consist of 2 periods. During Period 1, you will receive a single dose of Exenatide MPF or two doses of Byetta® at a 12-hour interval. Byetta® is the existing and registered

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Part A; Gender: healthy male or female Age: 18 - 65 years, inclusive Body Mass Index: >22.0 - 25.0 -

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of Exenatide MPF Sustained Release formulation following two subsequent rising doses in healthy volunteers versus a reference treatment in healthy volunteers To assess the safety and tolerability of a repeated dosing regimen of Exenatide MPF Sustained Release formulation in type 2 diabetes mellitus (T2DM) patients	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)