A single-center, single-blind study to investigate skin response to sub-therapeutic doses of taspoglutide in GLP-1 analogue naive healthy volunteers

A single-center, single-blind study to investigate skin response to sub-therapeutic doses of taspoglutide in GLP-1 analogue naive healthy volunteers - Skin response to subtherapeutic doses of taspoglutide

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34382

Enrollment

Registered

2010-12-01

Start date

2010-12-08

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

diabetes Diabetes Mellitus type 2

Interventions

Taspoglutide skin pricks, taspoglutide intradermal injections, positive and negative controls

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male or female Age : 18-65 yrs, inclusive BMI : 20.0-35.0 kg/m2, inclusive

Exclusion criteria

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 90 days from the start of the study. In case of having participated in more than 3 other drug studies (for men) / more than 2 other drug studies (for women) in the 10 months prior to the start of this study, or when having donated more than 1.5 liters of blood (for men) / more than 1.0 liters of blood (for women) in the 10 months prior to the start of this study

Design outcomes

Primary

Measure	Time frame
To generate skin test data in healthy subjects (never exposed to taspoglutide or any product with a similar mechanism of action) who will serve as a control group for patients* skin test study and will allow the valid interpretation of the test results.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)