A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618188
• Other study ID #: NN1218-3978
• Secondary ID: U1111-1126-09002
• Status: Completed
• Phase: Phase 1
• Start date: June 11, 2012
• Est. completion date: September 7, 2012

Study information

• Verified date: December 2018
• 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 properties (the effect of the investigated drug on the body) of NN1218 in subjects with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 7, 2012
• Est. primary completion date: September 7, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitus for more than 12 months

• Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion for more than 12 months

• Body mass index (BMI) between 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 trial start

• 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 substitute products during the inpatient period

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Faster-acting insulin aspart
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
• insulin aspart
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.

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 (4)

Haahr H, Hövelmann U, Brøndsted L, Adrian CL, Nosek L, Heise T. Higher Early Insulin Exposure and Greater Early Glucose-lowering Effect with Faster-acting Insulin Aspart in Patients with Type 1 Diabetes Mellitus (T1DM). Diabetes 2014; 63 ((Suppl 1)): A233 (abstract 910-P)

Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subje — View Citation

Heise T, Hövelmann U, Brøndsted L, Adrian CL, Nosek L, Haahr H. Faster-acting insulin aspart: earlier onset of appearance and greater early pharmacokinetic and pharmacodynamic effects than insulin aspart. Diabetes Obes Metab. 2015 Jul;17(7):682-8. doi: 10.1111/dom.12468. Epub 2015 May 8. — View Citation

Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. Faster Onset and Greater Early Exposure and Glucose-Lowering Effect with Faster-Acting Insulin Aspart vs. Insulin Aspart: A Pooled Analysis in Subjects with Type 1 Diabetes. Diabetes. 2016; Suppl. 1: A239. doi:10.2337/db16-861-1374 http://dx.doi.org/10.2337/db16-861-1374

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the glucose infusion rate curve		From 0 to 2 hours
Secondary	Area under the glucose infusion rate curve		From 0 to 12 hours
Secondary	Maximum glucose infusion rate		Within 0 to 12 hours after dosing
Secondary	Time to maximum glucose infusion rate		Within 0 to 12 hours after dosing

External Links

•   Clinical Trials at Novo Nordisk