Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics

Phase 1

Completed

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

• Registration Number: NCT01002768
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes.

The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Body mass index 18.0-28.0 kg/m^2 (both inclusive)

Read More

Exclusion Criteria

• Use of insulin glargine within 3 months prior to first dosing of investigational product in this trial
• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
• Smoker
• Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IDeg	insulin degludec	-
IGlar	insulin glargine	-

Primary Outcome Measures

Name	Time	Method
Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration	Within 0-46 hours after last trial product administration

Secondary Outcome Measures

Name	Time	Method
Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose	Within 0-46 hours after last trial product administration
Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L	Within 0-46 hours after last trial product administration
Time from start of hypoglycaemic induction until each level of plasma glucose is reached	Within 0-46 hours after last trial product administration
Hypoglycaemic symptoms score during recovery from hypoglycaemia	Within 0-46 hours after last trial product administration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇹 Graz, Austria