DETERMINE: Detemir vs NPH

University of California, Los Angeles (UCLA)

Status and phase: Enrolling; Phase 2

Conditions: Gestational Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: Insulin NPH; Drug: Insulin Detemir

Study type: Interventional

Funder types: Other

Identifiers

NCT05124457

DETERMINE

Details and patient eligibility

About

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

Full description

Insulin detemir has been used and is FDA approved for type 1 diabetes in pregnancy women and its safety has been well established. At this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin NPH. The most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to NPH both during pregnancy and outside of pregnancy. Diabetes mellitus (DM) is the most common diagnosis in pregnancy and its incidence is continuing to increase. Recent epidemiologic reports place the risk of pre-gestational diabetes at 1-2% and gestational diabetes (GDM) at 12.5%. Risk factors for type 2 diabetes (T2DM) and GDM include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy. Suboptimal control of DM in pregnancy confers significant morbidity on both the mother and fetus, including increased risk of preeclampsia, preterm delivery, perineal lacerations, cesarean delivery, neonatal hypoglycemia, and NICU admissions.

Enrollment: 336 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.

Exclusion criteria

1. Multiple Gestation
2. Type 1 Diabetes mellatus
3. Age < 18
4. Known or suspected hypersensitivity to NPH or insulin detemir
5. Known fetal major malformations
6. Chronic renal or hepatic insufficiency
7. Known to be HIV, Hepatitis B, or Hepatitis C positive
8. Indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery)
9. Insulin dependent before conception

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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336 participants in 2 patient groups

Insulin Detemir

Experimental group

Description:

Patients are to receive insulin detemir as long acting insulin to control blood sugars

Treatment:

Drug: Insulin Detemir

Insulin NPH

Active Comparator group

Description:

Patients are to receive insulin NPH as long acting insulin to control blood sugars

Treatment:

Drug: Insulin NPH