CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,609 enrolled
Drug / intervention
Insulin degludec +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03078478
NCT03078478Phase 3Completed
CompareCT.gov

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

Novo Nordisk A/S·interventional·Posted Mar 13, 2017·Updated Jan 11, 2022

In Brief

A Phase 3 clinical trial evaluating Insulin degludec and Insulin glargine for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 1,609 participants across 229 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesCanada, Denmark, Estonia, Germany, Greece, Hungary, Norway, Poland, Puerto Rico, Romania, Serbia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 13, 2017
Enrollment StartMar 13, 2017
Primary CompletionFeb 13, 2019
Study CompletionMar 4, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.3 years ago

Interventions

Insulin degludecdrug

For subcutaneous (s.c., under the skin) injection once daily

Insulin glarginedrug

For subcutaneous (s.c., under the skin) injection once daily