RecruitingPhase 2NCT05124457

DETERMINE: Detemir vs NPH

A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study


Sponsor

University of California, Los Angeles

Enrollment

336 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (DETERMINE) is comparing two types of long-acting insulin — insulin detemir (a newer insulin analog) and NPH insulin (an older standard) — for managing blood sugar during pregnancy in women who have type 2 diabetes or gestational diabetes (diabetes that develops during pregnancy) and need insulin. The goal is to find out which insulin is safer and more effective for mother and baby. **You may be eligible if...** - You are a pregnant woman aged 18 or older - You have pre-existing type 2 diabetes or gestational diabetes that requires insulin to control blood sugar during pregnancy - You do not have type 1 diabetes **You may NOT be eligible if...** - You are carrying multiple babies (twins, triplets, etc.) - You have type 1 diabetes - You have known allergy to NPH insulin or insulin detemir - You have chronic kidney or liver disease - You are HIV positive or have Hepatitis B or C - You have a known major fetal abnormality or are scheduled for premature delivery - You were already on insulin before you became pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInsulin Detemir

Patients are to receive insulin detemir

DRUGInsulin NPH

Patients are to receive insulin NPH


Locations(1)

University of California, Los Angeles

Los Angeles, California, United States

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NCT05124457


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