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

Phase 1

Completed

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

• Registration Number: NCT00964964
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SIBA 3W	insulin degludec	-
SIBA 3W	placebo	-
SIBA OD	insulin degludec	-

Primary Outcome Measures

Name	Time	Method
Total number of periods where carbohydrate supplementation is needed during the treatment	Assessed every day of the two in-house stays of nine days

Secondary Outcome Measures

Name	Time	Method
Frequency of adverse events (AEs)	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	Assessed every day of the two in-house stays of nine days and one follow-up by telephone