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Hormone Therapy

Metformin vs Insulin for Gestational Diabetes (DECIDE Trial)

Phase 4

Recruiting

Led By Kartik Venkatesh, MD, PhD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

GDM diagnosis between 20 0/7 - 31 6/7 weeks based on project gestational age

Must not have

Known fetal aneuploidy based on invasive testing or positive for aneuploidy on cell-free fetal DNA screening

Renal disease (serum creatinine >1.3 mg/dL) due to the potential impact of metformin on renal function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years of age.

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

"This trial is comparing the effectiveness of taking metformin pills versus injecting insulin for pregnant individuals with gestational diabetes. The study aims to see if metformin is as good as insulin in preventing pregnancy

Who is the study for?

This trial is for pregnant individuals diagnosed with gestational diabetes who require medication. They will be part of a study to compare the effectiveness and safety of metformin, an oral drug, versus insulin injections. Participants will be monitored from pregnancy through two years after birth.

What is being tested?

The DECIDE trial is testing whether metformin is as effective as insulin in reducing adverse outcomes during pregnancy caused by gestational diabetes. It's a randomized controlled trial where participants are assigned to either the metformin or insulin group randomly.

What are the potential side effects?

Metformin may cause side effects like nausea, stomach upset, or diarrhea. Insulin can lead to low blood sugar levels (hypoglycemia), weight gain, and at the injection site might cause reactions such as redness or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I was diagnosed with gestational diabetes between 20 and 31 weeks of pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My pregnancy test showed a chromosome abnormality in the fetus.

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My kidney function is reduced (creatinine >1.3 mg/dL).

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I cannot take metformin or insulin due to severe side effects or allergies.

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I have a history of diabetes before pregnancy, was diagnosed with gestational diabetes before 20 weeks, or had an A1c over 6.5%.

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My fasting blood sugar has been over 115 mg/dl for most of the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years of age.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years of age.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years of age. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

A neonatal composite adverse outcome of large-for-gestational-age (LGA) birthweight, hypoglycemia, hyperbilirubinemia, and/or death.

Child body mass index (BMI) at 2 years of age

Secondary study objectives

Adiposity (child)

Adiposity (maternal)

Anthropometry (child)

+21 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: MetforminExperimental Treatment1 Intervention

Metformin as either immediate- or extended-release formulations can be utilized, and titrated to a maximum daily dose of 2,500 mg. Participants receiving metformin will have insulin added only if they have not achieved euglycemia for at least 30% of glucose values after generally receiving the maximum daily dose of metformin of 2,500 mg, or in select situations in the setting of participant intolerance due to mild gastrointestinal symptoms. Participants will be asked to continue taking metformin after treatment supplementation with insulin.

Group II: InsulinExperimental Treatment1 Intervention

Insulin will be initiated utilizing clinical standards using trimester-specific weight-based dosing criteria, including both basal and prandial insulins for up to a total of 4 daily injections. Consistent with clinical practice, some people may be managed with a single dose of intermediate- or long-acting insulin at night to treat isolated fasting hyperglycemia, while others may require additional treatment of postprandial hyperglycemia with shorter-acting insulin. The sites' insulin formularies include rapid- (Novolog and Humalog), intermediate- (Humulin N, Novolin N, and NPH), and long-acting insulins (Detemir and Lantus).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

Insulin

2000

Completed Phase 4

~4280