Safety and Tolerability of NN9068 in Healthy Male Volunteers

NCT00983021 | Completed Phase 1

• 3 other identifiers: NN9068-36322009-011269-95U1111-1111-8859
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (4)

A

EXPERIMENTAL

Drug: insulin degludec/liraglutide; Drug: placebo

B

EXPERIMENTAL

Drug: insulin degludec; Drug: placebo

C

ACTIVE COMPARATOR

Drug: liraglutide; Drug: placebo

D

EXPERIMENTAL

Drug: insulin degludec; Drug: liraglutide

Interventions

insulin degludec/liraglutide DRUG

Single, simultaneous dose of NN9068, injected s.c. (under the skin)

Also known as: NN9068

A

insulin degludec DRUG

Single, simultaneous dose of NN1250, injected s.c. (under the skin)

Also known as: NN1250

B; D

liraglutide DRUG

Single, simultaneous dose of NN2211, injected s.c. (under the skin)

Also known as: NN2211

C; D

placebo DRUG

Single, simultaneous dose of placebo, injected s.c. (under the skin)

A; B; C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related 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: 10.1002/jcph.549. Epub 2015 Jul 14.

  PMID: 25998481 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

IDegLira; insulin degludec; Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

DE (1)