An interventional non-therapeutic study to assess ex vivo basophil activation in response to various preparations of taspoglutide

• Conditions: Diabetes; MedDRA version: 14.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-001935-21-IT
• Lead Sponsor: IPSEN PHARMA SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 29

Inclusion Criteria

- Subjects who, during one of the Roche T-Emerge Programme studies,
experienced a serious or non-serious adverse event (AE) that is
suggestive of a possible systemic allergic reaction to the study drug (per
the Investigator's assessment).
- Ability and willingness to give written informed consent and to provide
a blood sample for the BAT.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

• Subjects who participated in any other clinical study within 30 days
prior to screening or who may enter another clinical study during the
course of this study.
• Subjects who experienced a systemic allergic reaction, during one of
the Roche T-Emerge Programme Studies, more than 24 months prior to
screening.
• Subjects who received immunosuppressants within 1 week prior to
screening.
• Subjects who received any GLP-1 mimetic/analogue other than
taspoglutide at any time.
• Subjects who received taspoglutide since the last administration in
the T-Emerge Programme.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified