N/A
N=105
Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy
Diabetes, Gestational · Diabetes, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01837680 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Glycemic Control — 109.5; 107.4 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Insulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- St. Luke's-Roosevelt Hospital Center
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycemic Control |
109.5; 107.4 | — |
| SECONDARY Number of Patients Obtaining Glycemic Control |
28; 35 | — |
| SECONDARY Time to Achieve Glycemic Control |
5; 5 | — |
| SECONDARY Average Fasting Glucose |
100.7; 97.3 | — |
| SECONDARY Post-prandial Blood Glucose |
115.2; 112.9 | — |
| SECONDARY Weight Gain |
27.7; 28.6 | — |
| SECONDARY Neonatal Weight |
3230; 3235 | — |
| SECONDARY Gestational Age at Delivery |
38.9; 38.8 | — |
| SECONDARY Maternal Hypoglycemia |
11; 16 | — |
| SECONDARY Neonatal Bilirubin |
— | — |
| SECONDARY Intensive Care Admissions |
3; 6 | — |
| SECONDARY Delivery Mode |
— | — |
| SECONDARY Birth Rate |
42; 45 | — |
| SECONDARY Shoulder Dystocia |
— | — |
| SECONDARY Polyhydramnios |
— | — |
| SECONDARY Neonatal Hypoglycemia |
0; 2 | — |
Summary
The aim of this study is to compare glycemic control in pregnant women treated with insulin Detemir and pregnant women treated with NPH insulin. These women are diagnosed with gestational diabetes (GDM) in the current pregnancy or have a preexisting diagnosis of type 2 diabetes (T2DM) at the onset of pregnancy. Our hypothesis is that there is no difference between these two treatment modalities in terms of glycemic control in diabetes.
Eligibility Criteria
Inclusion criteria
- All pregnant women with a viable singleton or multiple gestation at ≤34 weeks with gestational diabetes diagnosed in their current pregnancy requiring medical therapy. "Early diagnosis" GDM patients will also be included; which is defined as a diagnosis made prior to 24 weeks.
- Women with known preexisting type 2 diabetes that are in need of medical therapy.
Exclusion criteria
- Patients <18 years of age
- a diagnosis of GDM outside of the gestational age stated above
- known allergy/prior adverse reaction to insulin NPH or insulin detemir.
- type 1 diabetes
Data sourced from ClinicalTrials.gov (NCT01837680). 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.