Insulin Glargine for Diabetes in Pregnancy

Overseen By Marwan Ma'ayeh, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Eastern Virginia Medical School

Must be taking: Insulin

Must not be taking: Metformin

Disqualifiers: Fetal anomaly, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether taking insulin glargine, a type of insulin, twice a day is more effective than once a day for managing blood sugar in pregnant patients with pregestational diabetes. Participants will be divided into two groups: one taking insulin once daily and the other twice daily. The primary goal is to determine if twice-daily doses maintain more stable blood sugar levels. The trial seeks pregnant individuals with Type II diabetes, between 24 and 28 weeks of pregnancy, who are already using or willing to use a continuous glucose monitor. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Do I need to stop my current medications for the trial?

Yes, you will need to stop taking other anti-diabetic medications like metformin, but you can continue using short-acting insulin.

What is the safety track record for insulin glargine?

Research has shown that insulin glargine is safe for use during pregnancy. Studies have found no safety concerns when pregnant women use it to manage diabetes, indicating it does not harm the mother or baby. Further evidence supports that insulin glargine does not negatively affect pregnancy outcomes. Overall, it appears well-tolerated for controlling blood sugar in pregnant women with diabetes. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about insulin glargine for diabetes in pregnancy because it offers a potentially more flexible dosing strategy than traditional insulins. Unlike standard insulin treatments that may require multiple daily injections to manage blood sugar levels effectively, insulin glargine can be administered either once or twice daily. This flexibility could help tailor treatment to individual needs, potentially improving blood sugar control and convenience for pregnant individuals managing diabetes. The potential for more stable and prolonged blood sugar regulation makes insulin glargine an intriguing option for enhancing pregnancy outcomes.

What is the effectiveness track record for insulin glargine in managing pregestational diabetes in pregnancy?

Research has shown that insulin glargine is safe and effective for controlling blood sugar in pregnant women with diabetes. In this trial, participants will receive insulin glargine either once daily or twice daily. One study found that using insulin glargine twice a day improves blood sugar control more than using it once a day. Maintaining good blood sugar levels is important to prevent complications for both the mother and baby. Insulin glargine provides a steady release of insulin, which is crucial as insulin needs change during pregnancy. Overall, insulin glargine is a reliable option for managing diabetes during pregnancy. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for pregnant individuals with pregestational diabetes. Participants will be randomly assigned to one of two groups to compare the effectiveness of insulin glargine dosing schedules.

Inclusion Criteria

The patient is between 24 weeks 0 days and 28 weeks 0 days of gestation at the time of enrollment. Gestational age will be determined by last menstrual period, confirmed with a first trimester ultrasound, per the recommended guidelines by the American College of Obstetricians and Gynecologists

I am older than 18 years.

I am using or open to using a glucose monitor for my sugar levels.

Exclusion Criteria

I am allergic to or cannot use insulin glargine due to another health condition.

I am taking diabetes medication, but not short-acting insulin.

Known or suspected fetal anomaly or aneuploidy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to take insulin glargine once or twice daily, with continuous glucose monitoring to track blood sugar levels

20 weeks

Regular visits for glucose monitoring and insulin adjustment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including delivery outcomes and neonatal health

Up to 1 year following delivery

Follow-up visits post-delivery for mother and child

What Are the Treatments Tested in This Trial?

Interventions

• Insulin Glargine

Trial Overview The study aims to determine if taking insulin glargine twice daily offers better blood sugar management than a once-daily dose in managing pregestational diabetes during pregnancy, using continuous glucose monitoring.

How Is the Trial Designed?

Group I: Twice-Daily Insulin Glargine Experimental Treatment 1 Intervention

Participants randomized to this arm will take insulin glargine twice daily

Group II: Once-Daily Insulin Glargine Active Control 1 Intervention

Participants randomized to this arm will take insulin glargine once daily

Who Is Running the Clinical Trial?

Eastern Virginia Medical School

Lead Sponsor

Trials

77

Recruited

16,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11965006/

Insulin glargine 300 U/mL safety data in pregnancy - PMC The results of our recent analysis of global PV data suggest that Gla‐300 could be used for glycaemic control in pregnant women with diabetes.

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/93/NCT07224893/Prot_SAP_000.pdf

Once-Daily Versus Twice-Daily Insulin Glargine in the ... In pregnant patients with pre-gestational diabetes, twice daily insulin glargine use is associated with improved glucose control compared to ...

3. ajog.org ajog.org/article/S0002-9378(25)00645-3/abstract

Diabetes in pregnancy and major new advances ... Pregestational diabetes complicates 1% to 2% of all pregnancies. Achievement of euglycemia prevents adverse maternal, fetal, and neonatal ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S187140212100014X

Use of insulin glargine during pregnancy: A review Insulin glargine can be continued safely during pregnancy in women who are already taking it prior to pregnancy and have achieved good glycemic control with it.

5. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/am-pdf/10.1111/dom.16295

Insulin glargine 300 U/mL safety data in pregnancy The results of our recent analysis of global PV data suggest that. Gla-300 could be used for glycaemic control in pregnant women with diabetes.

6. diabetesjournals.org diabetesjournals.org/diabetes/article/71/Supplement_1/1056-P/146119/1056-P-Reported-Pregnancy-Outcomes-with-Insulin

1056-P: Reported Pregnancy Outcomes with Insulin Glargine ... The results indicate no safety issues with insulin glargine use during pregnancy. J. Westerbacka: Employee; Sanofi, Stock/Shareholder; Sanofi.

7. dmsjournal.biomedcentral.com dmsjournal.biomedcentral.com/articles/10.1186/s13098-022-00925-7

Maternal and neonatal outcomes with the use of long acting ... Findings suggest no significant differences in the maternal, perinatal and neonatal outcomes between intermediate and long-acting insulin analogues.