EUCTR2008-008306-43-DE
Active, not recruiting
Not Applicable
A Trial Investigating the Pharmacokinetic Properties of NN1250 in Children, Adolescents and Adults with Type 1 Diabetes
ConditionsType I diabetes mellitusMedDRA version: 12.0Level: LLTClassification code 10045228Term: Type I diabetes mellitus
DrugsLantus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type I diabetes mellitus
- Sponsor
- ovo Nordisk A/S
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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