A trial assessing pharmacokinetic and pharmacodynamic responses after micro-doses of ZP4207 administered subcutaneously to patients with type 1 diabetes mellitus with reference to freshly reconstituted lyophilized glucago

Phase 1

• Conditions: Type 1 Diabetes mellitus; MedDRA version: 19.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-002617-21-DE
• Lead Sponsor: Zealand Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-15
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

- Male and female patients with T1D for at least one year, as defined by the American Diabetes Association 1
- Age between 18 and 64 years, both inclusive
- Diabetes managed using an insulin infusion pump for at least 1 week prior to screening
- Stable disease with HbA1c less than 8.5%
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Previous exposure to ZP4207 or previously randomized to this trial
• Known or suspected allergy to trial product(s) or related products
• Receipt of any investigational drug within 3 months prior to Screening

Study & Design

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