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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Drug: insulin glargine

Drug: insulin degludec

Study type

Interventional

Funder types

Industry

Identifiers

NCT01002768

NN1250-3538

U1111-1111-8843 (Other Identifier)

2008-008356-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

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)