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Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy

NCT03620890 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2021-09-16

Study results available
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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).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Neutral Protamine Hagedorn (NPH)

NPH will peak between 4-12 hours after injection with a duration of action around 14 hours

DRUG

Detemir insulin

Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Michal Fishel Bartal, MD · University of Texas Health Science Center of Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-04
Primary Completion
2020-07-29
Completion
2020-07-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03620890 on ClinicalTrials.gov