NCT02964104

A Trial Investigating the Safety, Tolerability, Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Pharmacodynamics (the Effect of the Investigated Drug on the Body) of Insulin 287 in Subjects With Type 2 Diabetes

A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) for Subcutaneous Administration in Subjects With Type 2 Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 287 in subjects with type 2 diabetes.

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Insulin icodec	Administered once weekly subcutaneously (s.c., under the skin) for 35 days
DRUG	placebo	Administered once daily subcutaneously for 35 days
DRUG	insulin degludec	Administered once daily subcutaneously for 35 days
DRUG	placebo	Administered once weekly subcutaneously for 35 days

Timeline

• Start date: 2016-11-15
• Primary completion: 2017-12-12
• Completion: 2017-12-12
• First posted: 2016-11-15
• Last updated: 2021-08-27

Locations

1 site across 1 country: Germany