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

Diabetes Clinical Trial

Official title:

A Trial Assessing the Number of Hypoglycaemic Episodes and Glycaemic Variability During Two Different Regimens of SIBA 200 U/ml in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964964
• Other study ID #: NN1250-3765
• Secondary ID: 2009-011959-53
• Status: Completed
• Phase: Phase 1
• First received: August 24, 2009
• Last updated: November 26, 2013
• Start date: August 2009
• Est. completion date: September 2009

Study information

• Verified date: November 2013
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec
Insulin degludec injected s.c. (under the skin) three times weekly
• insulin degludec
Insulin degludec injected s.c. (under the skin) once daily for one week
• placebo
Placebo injected s.c. (under the skin) four times weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of periods where carbohydrate supplementation is needed during the treatment		Assessed every day of the two in-house stays of nine days	No
Secondary	Frequency of adverse events (AEs)		Assessed every day of the two in-house stays of nine days and one follow-up by telephone	No
Secondary	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	Yes

External Links

•   Clinical Trials at Novo Nordisk