A Trial Assessing Changes in Blood Sugar and the Number of Periods Where Supplementation of Carbohydrate is Needed to Treat Low Blood Sugar, During Two Different Treatment Regimens of NN1250 in Type 1 Diabetics

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Drug: placebo

Drug: insulin degludec

Study type

Interventional

Funder types

Industry

Identifiers

NCT00964964

NN1250-3765

2009-011959-53 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim is to compare changes in blood sugar and the number of periods where carbohydrate supplementation is needed to treat low blood sugar, during two different treatments with NN1250 (insulin degludec), a soluble insulin basal analogue (SIBA) in subjects with type 1 diabetes.

Enrollment

18 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 1 diabetes mellitus for at least 12 months
Glycosylated haemoglobin (HbA1c) between 7.5 and 9% (both inclusive)

Exclusion criteria

Donation or loss of more than 500 ml blood or plasma within three months prior to this trial
Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) or not able or willing to refrain from smoking and the use of nicotine gum or transdermal nicotine patches during the in-house periods
Prior or current treatment with metformin or thiazolidinediones