NCT03078478

A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,609 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Europe and North America. The aim of the trial is to compare the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without oral antidiabetic drugs. Due to change in glycaemic data collection process, this trial is amended to allow for a full 36 weeks (maintenance 2 period) of the use of the new process.

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Insulin degludec	For subcutaneous (s.c., under the skin) injection once daily
DRUG	Insulin glargine	For subcutaneous (s.c., under the skin) injection once daily

Timeline

• Start date: 2017-03-13
• Primary completion: 2019-02-13
• Completion: 2019-03-04
• First posted: 2017-03-13
• Last updated: 2022-01-11
• Results posted: 2020-03-12

Locations

229 sites across 12 countries: United States, Canada, Denmark, Estonia, Germany, Greece, Hungary, Norway, Poland, Puerto Rico, Romania, Serbia

Regulatory

• FDA-regulated drug study