Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/13/2018 |
| Start Date: | September 4, 2018 |
| End Date: | September 1, 2020 |
| Contact: | Michal Fishel Bartal, MD |
| Email: | Michal.F.Bartal@uth.tmc.edu |
| Phone: | 713-500-6421 |
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy: a Comparative-effectiveness, Open Label, Randomized Controlled Trial
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).
rates of composite neonatal outcome and maternal hypoglycemia events in women with Type 2
Diabetes Mellitus (T2DM).
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
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
Phone: 713-500-6421
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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