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NCT03620890 · ClinicalTrials.gov registry record · Phase 4
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
A Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 4
- Development phase
- 108
- Enrollment target
NCT03620890: Completed Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
NCT03620890 is a Phase 4 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 108 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03620890, a Phase 4 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 108 participants
- Enrollment target
Study 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).
Primary Outcome
Composite Adverse Neonatal Outcome includes 1 or more of any of the following: * Neonatal intensive care unit (NICU) admission or * Neonatal hypoglycemia (\<40 mg/dL in the first 24 hours of life and less than 50 mg/dL after) or requiring medical therapy or * Respiratory distress (need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure or ventilation at the first 24 hours of life or * Shoulder dystocia - defined as the need for any extra ma
Interventions
- DRUG Neutral Protamine Hagedorn (NPH)
- DRUG Detemir insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2018-09-04 |
| Est. Completion | 2020-07-29 |
| Phase | Phase 4 |
What the finished NCT03620890 record still lists
NCT03620890 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Neutral Protamine Hagedorn (NPH) is the first listed.
NCT03620890 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03620890 about?
NCT03620890 is a clinical study titled "Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy". 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).
What is the current status of trial NCT03620890?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 108 participants. The study started on 2018-09-04. Estimated completion is 2020-07-29.
What interventions are being tested in trial NCT03620890?
The interventions under investigation include: Neutral Protamine Hagedorn (NPH) (DRUG), Detemir insulin (DRUG).
Who is sponsoring clinical trial NCT03620890?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03620890's enrollment target sits among peer trials
108 740th of 2000 higher than 1,256 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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