Safety and Tolerability of NN9068 in Healthy Male Volunteers

Healthy Clinical Trial

Official title:

A Trial to Test for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9068 and Compared With NN1250 and NN2211 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983021
• Other study ID #: NN9068-3632
• Secondary ID: 2009-011269-95U1
• Status: Completed
• Phase: Phase 1
• First received: September 22, 2009
• Last updated: February 6, 2017
• Start date: September 2009
• Est. completion date: December 2009

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 clinical trial is to investigate the safety, tolerability, level of drug exposure and effect of NN9068.

The trial participants will be randomised to 4 different treatments in trial, receiving trial products in a pre-defined order.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male subjects, who are considered to be generally healthy, based on an assessment of medical history, physical examination, and clinical laboratory data, as judged by the Investigator.

• Body mass index (BMI) between 18.0 and 27.0 kg/m2 (both inclusive)

• Body weight between 60 kg and 90 kg (both inclusive)

Exclusion Criteria:

• Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the current trial, as judged by the Investigator

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• insulin degludec/liraglutide
Single, simultaneous dose of NN9068, injected s.c. (under the skin)
• insulin degludec
Single, simultaneous dose of NN1250, injected s.c. (under the skin)
• liraglutide
Single, simultaneous dose of NN2211, injected s.c. (under the skin)
• placebo
Single, simultaneous dose of placebo, injected 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)

Kapitza C, Bode B, Ingwersen SH, Jacobsen LV, Poulsen P. Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy. J Clin Pharmacol. 2015 Dec;55(12):1369-77. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and severity of adverse events, number and severity of local tolerability issues at the injection site, number and severity of hypoglycaemic episodes		assessed 0-96 hours after trial product administration
Secondary	The area under the NN2211 concentration-time curve after single-dose		assessed 0-72 hours after trial product administration
Secondary	The area under the NN1250 concentration-time curve after single-dose		assessed 0-96 hours after trial product administration

External Links

•   Clinical Trials at Novo Nordisk