A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590836
• Other study ID #: NN5401-1979
• Secondary ID: 2011-003797-90U1
• Status: Completed
• Phase: Phase 1
• First received: April 30, 2012
• Last updated: February 9, 2017
• Start date: April 2012
• Est. completion date: June 2012

Study information

• Verified date: February 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 trial is to investigate the pharmacodynamic response (the effect of the investigated drug on the body) of insulin degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• 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

• Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months

• Body mass index (BMI) 18.0-28.0 kg/m^2 (both inclusive)

• Glycosylated haemoglobin (HbA1c) maximum 9.5 %

• Fasting C-peptide maximum 0.3 nmol/L

Exclusion Criteria:

• 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, use of nicotine gum or transdermal nicotine patches during the inpatient period

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

• Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec
Administered subcutaneously (s.c., under the skin) once daily (plus insulin aspart as bolus insulin as required).
• insulin degludec/insulin aspart
Single dose administered subcutaneously (s.c., 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 (1)

Heise T, Nosek L, Roepstorff C, Chenji S, Klein O, Haahr H. Distinct Prandial and Basal Glucose-Lowering Effects of Insulin Degludec/Insulin Aspart (IDegAsp) at Steady State in Subjects with Type 1 Diabetes Mellitus. Diabetes Ther. 2014 Jun;5(1):255-65. d — 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)
Secondary	Maximum glucose infusion rate (GIRmax)		At steady state (within 0-24 hours after last dosing)
Secondary	Area under the serum insulin degludec concentration-time curve during one dosing interval		At steady state (within 0-24 hours after last dosing)
Secondary	Maximum observed serum insulin degludec concentration		At steady state (within 0-24 hours after last dosing)
Secondary	Area under the serum insulin aspart concentration-time curve		From 0 to 12 hours
Secondary	Maximum observed serum insulin aspart concentration		Within 0-12 hours after dosing of IDegAsp

External Links

•   Clinical Trials at Novo Nordisk