Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy (Determin)

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Detemir insulin; Drug: Neutral Protamine Hagedorn (NPH)

Study type: Interventional

Funder types: Other

Identifiers

NCT03620890

HSC-MS-18-0575

Details and patient eligibility

About

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).

Enrollment: 108 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preexisting type 2 diabetes mellitus requiring medical treatment or
• overt diabetes diagnosed prior to 20 weeks of gestation using either Hemoglobin A1c (HBA1C) ≥ 6.5 or fasting glucose ≥126 mg/dl or random blood glucose ≥ 200 mg/dl or two step method ( 50g glucose challenge test (GCT) >135 mg/dl followed by 100 GCT with at least 2 values above thresholds: Fasting Blood Glucose (FBG) >90, 1 hr >180, 2 hr > 155, 3 hr > 140 mg/dl).
• Gestational age ≤20 weeks
• Willing to start insulin therapy or to continue insulin treatment during pregnancy
• Singleton or twin pregnancy

Exclusion criteria

• Known allergy/prior adverse reaction to NPH/detemir
• Patients <18y
• Known major fetal anomalies
• Diabetic nephropathy (Creatinine (Cr)≥1.5)
• Diabetic proliferative retinopathy
• Patients with Type 1 diabetes or gestational diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Neutral Protamine Hagedorn (NPH)

Active Comparator group

Description:

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

Treatment:

Drug: Neutral Protamine Hagedorn (NPH)

Detemir

Active Comparator group

Description:

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

Treatment:

Drug: Detemir insulin