A Phase 3 interventional study of Insulin and Metformin in Gestational Diabetes, sponsored by Women and Infants Hospital of Rhode Island. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-24.
Sponsored by Women and Infants Hospital of Rhode Island · Phase 3, Interventional, and Treatment
This study is a prospective, unmasked randomized clinical trial comparing the use of insulin vs combination insulin and metformin for treatment in women diagnosed with gestational diabetes mellitus (GDM). The investigator's hypothesis is that the combination of metformin and insulin will be superior to insulin alone to achieve tight glucose control during pregnancy.
The objective of this study is to compare the effectiveness of insulin alone vs the combination of insulin and metformin in treating patients with gestational diabetes (GDM). Currently, outside of pregnancy, the treatment of type 2 diabetes mellitus (T2DM) with both metformin and insulin is superior to using insulin alone. In pregnancy, insulin alone has traditionally been used, though some advocate the use of metformin alone as primary therapy. There have been no trials published to date specifically comparing combination therapy to insulin alone. Our hypothesis is that the combination of metformin and insulin will improve overall control of blood glucose, the improvement of which has been demonstrated to improve maternal and neonatal outcomes. Control of blood glucose will be determined by hemoglobin A1c at the time of delivery.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 1 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Women and Infants Hospital of Rhode Island is the lead sponsor of 92 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Insulin
Drug: Insulin · Drug: Metformin
Weight based insulin will be calculated using 0.7 units/kg/day in the first trimester, 0.8 units/kg/day in the second trimester and 1 units/kg/day in the third trimester. This total insulin will then be divided into short acting insulin and intermediate acting insulin per provider discretion.
Will be initiated at dose of 500 mg twice daily. If glycemic control is suboptimal, the dose of metformin will be increased to 1000 mg twice a day. Metformin will be titrated prior to increases in insulin.
Hgb A1c
Hgb A1c test
Time frame: collected at the time of delivery
Total daily dose of insulin
Total daily dose of insulin at the end of pregnancy
Time frame: Will be recorded on hospital admission for delivery
Glucose control
Average of fasting and 2 hour postprandial glucose values
Time frame: patients will collect glucose values fasting and 2 hrs postprandial every day from enrollment until delivery.
Incidence of maternal hypoglycemia
episodes of maternal hypoglycemia defined as glucose ≤70 mg/dL
Time frame: patients will be screened weekly for episodes of hypoglycemia until delivery
Change in hemoglobin A1c over the course of the pregnancy
If baseline hemoglobin A1c was collected as part of routine care prior to enrollment, this value will be compared to the hemoglobin A1c collected at delivery
Time frame: hemoglobin A1c will be collected at delivery (per above) and comparison performed after collection
Incidence of maternal side effects
maternal reported medication side effects (i.e. nausea, vomiting, diarrhea)
Time frame: Will be assessed weekly until delivery
Treatment acceptability
determined using Diabetes Treatment Satisfaction Questionnaire. Survey includes 8 questions that are answered on a scale of 0-6; 0 indicating the least and 6 the highest level of satisfaction. The individual questions will be compared. Total satisfaction will also be compared by summing the responses to all 8 questions on a composite scale of 0-48
Time frame: Will be collected postpartum after delivery
Maternal weight gain
weight gain through pregnancy
Time frame: This will be calculated as the difference from the weight measured at the inital prenatal visit (the specific timing of which is patient dependant) and at the time of admission for delivery
Incidence of hypertensive disorder of pregnancy
gestational HTN, superimposed pre-eclampsia, pre-eclampsia-eclampsia
Time frame: from enrollment through study completion (30 days after delivery)
Incidence of composite of adverse maternal outcomes
death, ICU admission, postpartum hemorrhage, blood transfusion, organ failure, chorioamnionitis/endometritis
Time frame: from enrollment through study completion (30 days after delivery)
Breast feeding status
Whether patient is breast feeding or bottle feeding upon discharge from the hospital after delivery
Time frame: Will be recorded at the time of hospital discharge after delivery (typically 2-4 days after delivery)
Mode of delivery
Mode of delivery
Time frame: recorded at time of delivery
Gestational age at delivery
Gestational age at delivery
Time frame: recorded at time of delivery
Infant birthweight (using age/sex matched percentiles)
Infant birthweight (using age/sex matched percentiles)
Time frame: measured at time of birth
Incidence of composite neonatal morbidity
Presence of any of the following: NICU admission, hypoglycemia, hyperbilirubinemia, birth trauma, stillbirth, respiratory distress syndrome, sepsis, neonatal death prior to discharge, 5 minute Apgar score \< 7, umbilical artery cord pH \<7.10
Time frame: from delivery through study completion (30 days after delivery)
Incidence neonatal hypoglycemia
hypoglycemia requiring intravenous treatment
Time frame: from delivery through study completion (30 days after delivery)
Plan to share: No
This study is terminated, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Women and Infants Hospital of Rhode Island