Safety and Tolerability of NN9068 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: insulin degludec/liraglutide; Drug: insulin degludec; Drug: liraglutide; Drug: placebo

• Registration Number: NCT00983021
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	insulin degludec/liraglutide	-
A	placebo	-
B	placebo	-
C	placebo	-
B	insulin degludec	-
C	liraglutide	-
D	insulin degludec	-
D	liraglutide	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The area under the NN2211 concentration-time curve after single-dose	assessed 0-72 hours after trial product administration
The area under the NN1250 concentration-time curve after single-dose	assessed 0-96 hours after trial product administration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany