NCT03570632

Brief Summary

Although major advancements have been made in improving glycemic management in type 1 diabetes mellitus (DM), women entering pregnancy with type 1 DM continue to be at dramatically increased risk for adverse maternal and neonatal outcomes, including hypertensive disorders of pregnancy (HDP). At present, there is a lack of effective preventive interventions for HDP, which are associated with significant maternal and neonatal morbidity and mortality. Clinical and in vitro data have shown promise for metformin in prevention of HDP in non-diabetic women. Metformin has a reassuring fetal safety profile and has been well studied in type 1 DM outside of pregnancy. The hypothesis to be tested in this application is that compared to usual care, daily oral metformin therapy initiated prior to 20 weeks' gestation in women with type 1 DM reduces the frequency of HDP.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
1mo left

Started Jul 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jul 2019May 2026

First Submitted

Initial submission to the registry

June 15, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
1 year until next milestone

Study Start

First participant enrolled

July 8, 2019

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

6.3 years

First QC Date

June 15, 2018

Last Update Submit

January 7, 2026

Conditions

Pregnancy in DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Rate of hypertensive disorders of pregnancy

    Delivery/End of pregnancy

Secondary Outcomes (3)

  • Home glucose levels throughout pregnancy

    Weekly, throughout pregnancy from enrollment to delivery

  • Birthweight

    Delivery/End of pregnancy

  • Neonatal morbidity

    Delivery/End of pregnancy

Other Outcomes (4)

  • Gestational weight gain

    At time of prenatal visits, throughout pregnancy from enrollment to delivery

  • Umbilical cord c-peptide

    Delivery/End of pregnancy

  • Umbilical cord glucose

    Delivery/End of pregnancy

  • +1 more other outcomes

Study Arms (2)

Usual care

NO INTERVENTION

Metformin

EXPERIMENTAL
Drug: Metformin

Interventions

MetforminDRUG

Participants randomized to metformin will receive metformin in addition to standard treatment of diabetes during pregnancy

Metformin

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly pregnant women are eligible to participate in the study
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women 18-50 years
  • /7 and 19 6/7 weeks of gestation
  • Diagnosed with type 1 DM prior to pregnancy.

You may not qualify if:

  • Known allergy or adverse reaction to metformin
  • Multiple gestation
  • Abnormal obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy
  • Medical comorbidities that increase risk for metformin use: renal insufficiency (creatinine \> 1.1 mg/dL), proteinuria (P:C \>0.3 or 24-hour urine protein \> 300 mg), active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes 3x above normal), inflammatory bowel disease (Crohn's and Ulcerative colitis), major hematologic disorder (including alloimmune and isoimmune thrombocytopenia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Pregnancy in Diabetics

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Maisa N Feghali, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 15, 2018

First Posted

June 27, 2018

Study Start

July 8, 2019

Primary Completion

October 30, 2025

Study Completion (Estimated)

May 31, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)