Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
Purpose
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).
Condition
- Diabetes Mellitus, Type 2
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Neutral Protamine Hagedorn (NPH) |
NPH will peak between 4-12 hours after injection with a duration of action around 14 hours |
|
|
Active Comparator Detemir |
Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours) |
|
More Details
- Status
- Completed
- Sponsor
- The University of Texas Health Science Center, Houston