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 A/S18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin degludec

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Total number of periods where carbohydrate supplementation is needed during the treatment

Time frame: Assessed every day of the two in-house stays of nine days

Secondary Outcomes

Frequency of adverse events (AEs)

Time frame: Assessed every day of the two in-house stays of nine days and one follow-up by telephone

Number of periods with low blood sugar during treatment