CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 145 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/NCT01570751
NCT01570751Phase 3Completed
CompareCT.gov

A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin

Novo Nordisk A/S·interventional·Posted Apr 4, 2012·Updated Mar 7, 2017

In Brief

A Phase 3 clinical trial evaluating insulin degludec and insulin glargine for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 145 participants across 46 sites in 2 countries.

Detailed Summary

This trial is conducted in the United States of America (USA). The aim of the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 4, 2012
Enrollment StartApr 1, 2012
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.2 years ago

Interventions

insulin degludecdrug

Cross-over trial, part 1: Individually adjusted IDeg administered subcutaneously (s.c., under the skin) once daily for 16 weeks in each treatment period.

insulin glarginedrug

Cross-over trial, part 2: Individually adjusted IGlar administered subcutaneously (s.c., under the skin) once daily for the 16 week run-in period followed by 16 weeks in each treatment period.