A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

This Trial is Conducted in Europe. The Aim of This Trial is to Investigate Pharmacokinetic (the Exposure of the Trial Drug in the Body) and Pharmacodynamic (the Effect of the Investigated Drug on the Body) Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02933853
• Other study ID #: NN1218-4265
• Secondary ID: 2016-000200-28U1
• Status: Completed
• Phase: Phase 1
• Start date: October 14, 2016
• Est. completion date: December 21, 2017

Study information

• Verified date: May 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects with Type 2 Diabetes Mellitus

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 21, 2017
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. The total number of subjects aged 65-75 years (both inclusive) must NOT exceed 25.

• Subjects diagnosed (clinically) with type 2 diabetes mellitus for at least 12 months (365 days) prior to the day of screening

• HbA1C below or equal to 9.5 % based on central laboratory analysis

Exclusion Criteria:

• Smoker (defined as a subject who is smoking more than one cigarette or the equivalent per day) who is not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period

• Surgery or trauma with significant blood loss (more than 500 mL) within the last 90 days prior to screening

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Faster-acting insulin aspart
A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.
• Insulin Aspart
A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Pieber TR, Svehlikova E, Brunner M, Halberg IB, Thomsen KMD, Haahr H. Fast-acting insulin aspart in subjects with type 2 diabetes: Earlier onset and greater initial exposure and glucose-lowering effect compared with insulin aspart. Diabetes Obes Metab. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin aspart concentration-time curve		From 0 to 30 minutes
Secondary	Maximum observed serum insulin aspart concentration		Within 0 to 12 hours after dosing
Secondary	Area under the glucose infusion rate curve		From 0 to t, where t is the last time where glucose infusion rate (GIR) exceeds zero (within 0 to 12 hours after dosing)
Secondary	Maximum glucose infusion rate		Within 0 to 12 hours after dosing