At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 108 enrolled
Drug / intervention
Neutral Protamine Hagedorn (NPH) +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.
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy: a Comparative-effectiveness, Open Label, Randomized Controlled Trial
The University of Texas Health Science Center, Houston·interventional·Posted Aug 8, 2018·Updated Sep 16, 2021
In Brief
A Phase 4 clinical trial evaluating Neutral Protamine Hagedorn (NPH) and Detemir insulin for Diabetes Mellitus, Type 2. Completed, enrolled 108 participants across 1 site.
Detailed Summary
To determine whether use of detemir compared to neutral protamine hagedorn (NPH) decreases rates of composite neonatal outcome and maternal hypoglycemia events in women with Type 2 Diabetes Mellitus (T2DM).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartSep 2018
Primary CompletionJul 2020
TodayJul 2026
First PostedAug 8, 2018
Enrollment StartSep 4, 2018
Primary CompletionJul 29, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.9 years ago
Interventions
Neutral Protamine Hagedorn (NPH)drug
NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
Detemir insulindrug
Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)