Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy

• Status: Completed
• Trial end date: 2020-07-29
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Insulin Detemir; Protamines

Criteria

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