Comparison of Two Identical NN1250 Formulations in Healthy Volunteers

A Trial to Test for Bioequivalence Between Identical NN1250 Formulations, IM1 and IM2, in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01193387

Enrollment

Registered

2010-09-01

Start date

2010-08-31

Completion date

2010-11-30

Last updated

2013-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

Brief summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate if two identical formulations of NN1250 (insulin degludec, IDeg) have the same level of drug exposure to the body.

Interventions

DRUGinsulin degludec

Each subject will be allocated to 2 single doses of trial product on 2 separate visits: One injection with formulation 1 and and one injection with formulation 2). Injected subcutaneously (under the skin).

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator * Body mass index 18.0-27.0 kg/m\^2 (both inclusive)

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 * Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches 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 (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner)

Design outcomes

Primary

Measure	Time frame
Area under the Insulin Degludec concentration-time curve	From 0 to 120 hours after single-dose
Maximum observed Insulin Degludec concentration	From 0 to 120 hours after single-dose

Secondary

Measure	Time frame
Area under the Insulin Degludec concentration-time curve	From 0 to infinity after single-dose

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026