A Trial Evaluating the Effect of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: insulin glargine; Drug: insulin degludec

• Registration Number: NCT01114542
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-04-29
• Study Start: 2010-05-03
• Study First Posted: 2010-05-03
• Primary Completion: 2010-08-10
• Study Completion: 2010-08-10
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-06
• Last Update Posted: 2017-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Current total daily insulin treatment lower than 1.2 (I)U/kg/day
• Body mass index 18.0-28.0 kg/m^2

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
• Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IGlar 0.8 U/kg	insulin glargine	-
IDeg 0.4 U/kg	insulin degludec	-
IDeg 0.6 U/kg	insulin degludec	-
IDeg 0.8 U/kg	insulin degludec	-
IGlar 0.4 U/kg	insulin glargine	-
IGlar 0.6 U/kg	insulin glargine	-

Primary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate curve during one dosing interval of Insulin Degludec at steady state	0-24 hours after dosing on day 8

Secondary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate curve during one dosing interval of insulin glargine at steady state	0-24 hours after dosing on day 8
Area under the concentration-time curve during one dosing interval at steady state for Insulin Degludec	0-24 hours after dosing on day 8
Area under the concentration-time curve during one dosing interval at steady state for insulin glargine	0-24 hours after dosing on day 8

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany