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Metformin in Women With Type 2 Diabetes in Pregnancy Trial

NCT01353391 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2020-03-03

No results posted yet for this study

Summary

Insulin is the standard treatment for the management of type 2 diabetes in pregnancy, however despite treatment with insulin, these women continue to face increased rates of adverse maternal and fetal outcomes. The investigators hypothesize that metformin use, in addition to treatment with insulin, will help with blood sugar control, lower the dose of insulin needed, lower weight gain, and improve baby outcomes.

Conditions

Interventions

DRUG

Metformin

500 mg daily OD from randomisation for 2 weeks, then 1000mg BID throughout the duration of pregnancy

DRUG

Placebo Comparator

500 mg daily OD from randomisation for 2 weeks, then 1000mg BID throughout the duration of pregnancy

Sponsors & Collaborators

  • University Health Network, Toronto

    collaborator OTHER

  • Sunnybrook Research Institute

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Denice Feig, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-25
Primary Completion
2019-06-05
Completion
2019-06-05

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01353391 on ClinicalTrials.gov