A Trial Evaluating the Effect of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Trial Evaluating the Pharmacodynamic Response of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114542
• Other study ID #: NN1250-1993
• Secondary ID: 2009-015897-36U1
• Status: Completed
• Phase: Phase 1
• First received: April 29, 2010
• Last updated: October 6, 2017
• Start date: May 3, 2010
• Est. completion date: August 10, 2010

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 10, 2010
• Est. primary completion date: August 10, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months

• Current total daily insulin treatment lower than 1.2 (I)U/kg/day

• Body mass index 18.0-28.0 kg/m^2

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

• Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec
Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)
• insulin glargine
Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)

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, Hövelmann U, Nosek L, Hermanski L, Bøttcher SG, Haahr H. Comparison of the pharmacokinetic and pharmacodynamic profiles of insulin degludec and insulin glargine. Expert Opin Drug Metab Toxicol. 2015;11(8):1193-201. doi: 10.1517/17425255.2015.1058 — 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 of Insulin Degludec at steady state		0-24 hours after dosing on day 8
Secondary	Area under the glucose infusion rate curve during one dosing interval of insulin glargine at steady state		0-24 hours after dosing on day 8
Secondary	Area under the concentration-time curve during one dosing interval at steady state for Insulin Degludec		0-24 hours after dosing on day 8
Secondary	Area under the concentration-time curve during one dosing interval at steady state for insulin glargine		0-24 hours after dosing on day 8

External Links

•   Clinical Trials at Novo Nordisk