Comparison of Insulin Alone to Insulin With Metformin to Treat Gestational Diabetes Mellitus

Stopped early · Phase 3

Conditions studied: Gestational Diabetes

In brief

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.

Key facts

Study ID

NCT03651531

Run by

Women and Infants Hospital of Rhode Island

People needed

1

Starts

2018-01-03

Expected to finish

2019-07-30

Last updated by the study team

2020-07-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Able to read and write English and/or Spanish and give written consent
• Diagnosis of GDM, defined as an abnormal glucose tolerance test performed after 12 weeks gestation using 1 of the 2 criteria below:
• 50 gram 1 hour oral diabetes screening testing yielding a result of > 200 mg/dL
• A 100 gram 3 hour oral glucose tolerance testing yielding >2 abnormal values (normal values defined as fasting blood glucose < 95, 1 hour < 180, 2 hour < 155 and 3 hour < 140)
• Singleton gestation
• Gestational age between 12 and 34 weeks and 6 days determined by last menstrual period (LMP) confirmed by ultrasound using criteria set forth by the ACOG (Committee on Obstetric Practice). If LMP is unknown then gestational age must be set by ultrasound prior to 20 weeks gestation.

You may not qualify if…

• Pre-existing DM either by diagnosis preceding pregnancy or hemoglobin A1c >6.5 collected during the current pregnancy
• Uncontrolled chronic hypertension, as this may alter maternal and perinatal outcomes measured.
• Multiple gestations
• Major fetal anomalies anticipated to require NICU admission
• Contraindication to metformin (allergy, history of lactic acidosis, pre-existing renal disease (Cr >1.5 mg/dL), active liver disease, current alcohol abuse).
• Vitamin B12 deficiency, as metformin reduces intestinal absorption of vitamin B12
• Medications known to effect glucose metabolism other than insulin and metformin as this may mask any effect between the two treatments.
• Known inability to tolerate metformin.

Where it is running

• Women & Infants Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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