CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 143 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/NCT01135992
NCT01135992Phase 3Completed
CompareCT.gov

A Trial Assessing the Implications of Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™: SIMPLIFY)

Novo Nordisk A/S·interventional·Posted Jun 3, 2010·Updated Jan 22, 2016

In Brief

A Phase 3 clinical trial evaluating insulin degludec and insulin glargine for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 143 participants across 27 sites.

Detailed Summary

This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in subjects with type 2 diabetes mellitus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 3, 2010
Enrollment StartJun 1, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.1 years ago

Interventions

insulin degludecdrug

Individually adjusted insulin degludec administered three times weekly with continued unchanged pre-trial OAD (oral anti-diabetic drug) treatment for 12 weeks

insulin glarginedrug

Subjects continue their pre-trial insulin glargine once daily plus OAD (oral anti-diabetic drug) treatment for four weeks before switch to insulin degludec