Phase 4
Completed N=108
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
Source: ClinicalTrials.gov NCT03620890 ↗Enrolled (actual)
108
Serious AEs
24.1%
Results posted
Aug 2021
Primary outcomePrimary: Number of Neonates With Composite Adverse Neonatal Outcome — 31; 35 Participants
◆ Published Evidence
Emerging
18citations · ~4 / year
Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial.
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).
Linked Publications
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Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.