A Trial Investigating the Within-subject Variability of NN1250 in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Randomised, Single-centre, Double-blind, Parallelgroup, Multiple Dose Trial Comparing the Within-subject Variability of SIBA and Insulin Glargine With Respect to Pharmacodynamic Response at Steady State Conditions in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961324
• Other study ID #: NN1250-1991
• Secondary ID: 2008-008308-42
• Status: Completed
• Phase: Phase 1
• First received: August 17, 2009
• Last updated: October 6, 2017
• Start date: July 27, 2009
• Est. completion date: October 26, 2009

Study information

• Verified date: October 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the variability in the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 26, 2009
• Est. primary completion date: October 26, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female aged 18-65 years (both inclusive)

• 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:

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)

• Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec
The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days
• insulin glargine
The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab. 2012 Sep;14(9):859-64. doi: 10.1111 — View Citation

Heise T, Kaplan K, Haahr HL. Day-to-Day and Within-Day Variability in Glucose-Lowering Effect Between Insulin Degludec and Insulin Glargine (100 U/mL and 300 U/mL): A Comparison Across Studies. J Diabetes Sci Technol. 2017 Sep 1:1932296817731422. doi: 10. — View Citation

Heise T, Korsatko S, Nosek L, Coester HV, Deller S, Roepstorff C, Segel S, Kapur R, Haahr H, Hompesch M. Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action. J Diabetes. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the glucose infusion rate curve during one dosing interval at steady state		0-24 hours (derived on treatment days 6, 9 and 12)
Secondary	Area under the NN1250 concentration-time curve during one dosing interval at steady state		0-24 hours (derived on treatment days 6, 9 and 12)

External Links

•   Clinical Trials at Novo Nordisk