CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 467 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/NCT01076647
NCT01076647Phase 3Completed
CompareCT.gov

A 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of Insulin naïve Subjects With Type 2 Diabetes Mellitus Currently Treated With OADs Qualifying for Intensified Treatment (BEGIN™: EASY™)

Novo Nordisk A/S·interventional·Posted Feb 26, 2010·Updated Mar 6, 2017

In Brief

A Phase 3 clinical trial evaluating insulin degludec and insulin glargine for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 467 participants across 105 sites in 7 countries.

Detailed Summary

This trial was conducted in Europe and North America. The aim of this clinical trial was to compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesBulgaria, Canada, France, Hungary, Netherlands, Romania, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 26, 2010
Enrollment StartMar 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.3 years ago

Interventions

insulin degludecdrug

Will be injected subcutaneously (under the skin) once daily three times weekly.

insulin glarginedrug

Will be injected subcutaneously (under the skin) once daily administered at the same time each day.