A Trial Investigating the Within-subject Variability of NN1250 in Subjects With Type 1 Diabetes

A Randomised, Single-centre, Double-blind, Parallelgroup, Multiple Dose Trial Comparing the Within-subject Variability of SIBA and Insulin Glargine With Respect to Pharmacodynamic Response at Steady State Conditions in Subjects With Type 1 Diabetes

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00961324

Enrollment

Registered

2009-08-18

Start date

2009-07-27

Completion date

2009-10-26

Last updated

2017-10-09

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

Conditions

Diabetes, Diabetes Mellitus, Type 1

Brief summary

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the variability in the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.

Interventions

DRUGinsulin degludec

The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days

DRUGinsulin glargine

The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Male or female aged 18-65 years (both inclusive) * Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * Body mass index 18.0-28.0 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

Design outcomes

Primary

Measure	Time frame
Area under the glucose infusion rate curve during one dosing interval at steady state	0-24 hours (derived on treatment days 6, 9 and 12)

Secondary

Measure	Time frame
Area under the NN1250 concentration-time curve during one dosing interval at steady state	0-24 hours (derived on treatment days 6, 9 and 12)

Countries

Germany

Outcome results

None listed

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