A Trial Investigating the Pharmacokinetic Properties ofNN5401 in Children, Adolescents and Adults with Type1 Diabetes

• Conditions: Type 1 Diabetes; MedDRA version: 12.1Level: LLTClassification code 10067584Term: Type 1 diabetes mellitus

• Registration Number: EUCTR2009-016779-31-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-27
• Last Update Posted: 3 December 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 and adolescents (male and female) between the 3. and 97. BMI percentile 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