Phase 4
N=108
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT03620890 ↗Enrolled (actual)
108
Serious AEs
24.1%
Results posted
Aug 2021
Primary outcome: Primary: Number of Neonates With Composite Adverse Neonatal Outcome — 31; 35 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Neutral Protamine Hagedorn (NPH) (Drug); Detemir insulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Neonates With Composite Adverse Neonatal Outcome |
31; 35 | — |
| SECONDARY Maternal Mean Fasting Glucose |
— | — |
| SECONDARY Maternal Mean Post Prandial Glucose |
— | — |
| SECONDARY Number of Maternal Subjects Who Experienced Hypoglycemic Events (<60 mg/dL) During Pregnancy |
8; 16 | — |
| SECONDARY Change in Maternal Weight During Pregnancy |
7.00; 9.00 | — |
| SECONDARY Number of Maternal Subjects Who Had Hypertensive Disorder During Pregnancy |
22; 27 | — |
| SECONDARY Number of Maternal Subjects Who Had Preeclampsia With Severe Features |
12; 16 | — |
| SECONDARY Number of Subjects Who Had Cesarean Delivery |
32; 30 | — |
| SECONDARY Number of Subjects Who Had Operative Vaginal Delivery |
1; 0 | — |
| SECONDARY Gestational Weeks at Delivery |
37.10; 37.00 | — |
| SECONDARY Number of Neonates Who Where Small for Gestational Age (SGA) |
4; 6 | — |
| SECONDARY Neonatal Hospital Admission Days |
4.0; 4.1 | — |
| SECONDARY # of Neonates Who Had 5-minute Apgar Score < 7 |
3; 2 | — |
| SECONDARY Number of Neonates Who Had Jaundice Requiring Therapy |
15; 11 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03620890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.