N/A
N=62
Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus
Gestational Diabetes Mellitus in Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT03106870 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation — 24; 27 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Insulin Mixtard (Drug); Metformin (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Ain Shams University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation |
24; 27 | — |
| SECONDARY Number of Participants With a Macrosomic Baby |
5; 12 | — |
| SECONDARY Number of Participants With Neonates Who Were Hypoglycemic |
5; 6 | — |
Summary
The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.
Eligibility Criteria
Inclusion Criteria
- Age 20 - 35 years.
- Gestational age: 20- 36 weeks gestation.
- Singleton pregnancy.
- Women with pregestational or gestational diabetes mellitus
Exclusion Criteria
- Pregnant women with secondary diabetes (e.g. those on chronic steroid therapy).
- Hypertensive patients.
- Women with impaired liver or renal function
- Non-compliant patients.
Data sourced from ClinicalTrials.gov (NCT03106870). 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.