CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 833 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/NCT01849289
NCT01849289Phase 3Completed
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A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™: ONCE)

Novo Nordisk A/S·interventional·Posted May 8, 2013·Updated Apr 7, 2017

In Brief

A Phase 3 clinical trial evaluating Insulin Degludec and Insulin Glargine for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 833 participants across 81 sites in 7 countries.

Detailed Summary

This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesBrazil, Canada, China, Romania, South Africa, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 8, 2013
Enrollment StartJun 2, 2013
Primary CompletionMay 15, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.2 years ago

Interventions

Insulin Degludecdrug

Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.

Insulin Glarginedrug

Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.