A Trial Investigating the Pharmacokinetic Properties of NN1250 in Children, Adolescents and Adults with Type 1 Diabetes

• Conditions: Type I diabetes mellitus; MedDRA version: 12.0Level: LLTClassification code 10045228Term: Type I diabetes mellitus

• Registration Number: EUCTR2008-008306-43-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-11
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male or female aged 6-65 years (both inclusive)
• Type 1 diabetes mellitus (as diagnosed clinically) = 12 months
• Body mass index for children: 15.0-20.0 kg/m² (both inclusive), for adolescents: 18.0-28.0 kg/m² (both inclusive) and for adults = 30.0 kg/m²

Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
• Not able or willing to refrain from smoking during the inpatient period
• Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods

Study & Design

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