116 Participants Needed

Metformin for Preventing Type 2 Diabetes After Gestational Diabetes

GW
Overseen ByGianna Wilkie, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Massachusetts, Worcester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using systemic steroids, you would not be eligible to participate.

What data supports the effectiveness of the drug Metformin for preventing type 2 diabetes after gestational diabetes?

Metformin is widely used as a first-line treatment for type 2 diabetes due to its effectiveness in controlling blood sugar levels, its safety profile, and its cost-effectiveness. It is often combined with other diabetes medications to enhance its efficacy.12345

Is metformin generally safe for humans?

Metformin is generally safe for humans when used as directed, but it can cause side effects like diarrhea, nausea, and vomiting. It is important to monitor liver and kidney function while taking it, and it may decrease vitamin B12 absorption.678910

How does the drug metformin differ from other treatments for preventing type 2 diabetes after gestational diabetes?

Metformin is unique because it has been shown to effectively reduce the risk of developing type 2 diabetes in women with a history of gestational diabetes, and it is well tolerated. Unlike some other treatments, metformin has a long history of safe use for blood sugar control, and it can be used alone or alongside lifestyle changes, making it a flexible option for prevention.1112131415

What is the purpose of this trial?

The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening for postpartum patients with pregnancies affected by GDM.

Research Team

GW

Gianna Wilkie, MD

Principal Investigator

UMASS Memorial Healthcare

Eligibility Criteria

This trial is for postpartum patients who had gestational diabetes (GDM) and show signs of high blood sugar. They must have been diagnosed with GDM in their third trimester, be able to give consent, speak English or Spanish, and be capable of undergoing glucose testing immediately after delivery at UMASS Memorial.

Inclusion Criteria

Have evidence of impaired glucose metabolism defined as fasting glucose value of ≥126 mg/dL or 2-hour glucose value of ≥200 mg/dL
Pregnancy complicated by GDM as diagnosed with traditional two step testing in the third trimester according to Carpenter-Coustan Criteria
Able and willing to provide informed consent
See 2 more

Exclusion Criteria

I was diagnosed with diabetes before becoming pregnant.
I cannot undergo an oral glucose tolerance test due to past surgeries or conditions.
I am currently taking steroids.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Postpartum day 1
1 visit (in-hospital)

Early Postpartum GDM Screening

Subjects are screened for GDM with a 2-hour glucose tolerance test during their postpartum hospitalization

Postpartum day 1
1 visit (in-hospital)

Standard of Care Postpartum Screening

Subjects receive the usual standard of care with a 2-hour glucose tolerance test at 6-12 weeks postpartum

6-12 weeks postpartum
1 visit (in-person)

Follow-up

Participants are monitored for glycemic outcomes and patient satisfaction after screening

6 weeks
1 visit (in-person)

Treatment Details

Interventions

  • Metformin Hydrochloride
Trial Overview The study aims to test a protocol where new mothers who had GDM are screened right after giving birth and then treated with Metformin Hydrochloride if they have high blood sugar levels.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Early Postpartum GDM ScreeningExperimental Treatment1 Intervention
Subjects who are randomly assigned to this condition will be screened for GDM with the recommended 2-hour glucose tolerance test during their postpartum hospitalization.
Group II: Standard of Care Postpartum ScreeningActive Control1 Intervention
Subjects randomized to the comparison condition will receive the usual standard of care. The standard of care will consist of screening with a 2 hour glucose tolerance test at 6-12 weeks postpartum.

Metformin Hydrochloride is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Metformin Hydrochloride for:
  • Type 2 diabetes
  • Polycystic ovary syndrome
🇺🇸
Approved in United States as Metformin Hydrochloride for:
  • Type 2 diabetes
  • Polycystic ovary syndrome
  • Gestational diabetes
🇨🇦
Approved in Canada as Metformin Hydrochloride for:
  • Type 2 diabetes
  • Polycystic ovary syndrome
🇯🇵
Approved in Japan as Metformin Hydrochloride for:
  • Type 2 diabetes

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials
372
Recruited
998,000+

Findings from Research

A systematic review of 33 randomized controlled trials found that various third-line treatments for type 2 diabetes, including insulin and GLP-1 analogues, significantly reduced hemoglobin A1c levels when used alongside metformin and sulphonylureas, with reductions ranging from -0.89% to -1.17%.
While insulin treatments were linked to weight gain and increased risk of hypoglycemia, DPP-4 inhibitors and GLP-1 analogues were weight-neutral or associated with weight loss, highlighting the importance of considering side effects when choosing diabetes therapies.
Choice of therapy in patients with type 2 diabetes inadequately controlled with metformin and a sulphonylurea: a systematic review and mixed-treatment comparison meta-analysis.McIntosh, B., Cameron, C., Singh, SR., et al.[2023]
In a randomized trial involving patients with type 2 diabetes, both metformin-vidagliptin (MF-VG) and metformin-glimepiride (MF-GP) combinations significantly reduced blood glucose levels and HbA1c after 12 weeks, showing similar efficacy.
Both treatment groups maintained normal liver and kidney function throughout the study, but the MF-GP group experienced numerically more cases of hypoglycemia, indicating a potential safety concern with this combination.
Comparative evaluation of efficacy and safety of combination of metformin-vidagliptin versus metfromin-glimepiride in most frequently used doses in patients of type 2 diabetes mellitus with inadequately controlled metformin monotherapy-A randomised open label study.Gupta, S., Khajuria, V., Tandon, VR., et al.[2020]
The triple drug fixed-dose combination (FDC) of dapagliflozin, sitagliptin, and metformin significantly reduced HbA1c levels more than the dual combinations of sitagliptin with metformin or dapagliflozin with metformin in patients with type 2 diabetes, with a mean reduction of -1.73% compared to -1.28% and -1.33%, respectively.
All treatment regimens were well tolerated, indicating that the FDC of dapagliflozin, sitagliptin, and metformin is both effective and safe for improving glycemic control in patients poorly managed on metformin alone.
Fixed-Dose Combination of Dapagliflozin + Sitagliptin + Metformin in Patients with Type 2 Diabetes Poorly Controlled with Metformin: Phase 3, Randomized Comparison with Dual Combinations.Sahay, RK., Giri, R., Shembalkar, JV., et al.[2023]

References

Choice of therapy in patients with type 2 diabetes inadequately controlled with metformin and a sulphonylurea: a systematic review and mixed-treatment comparison meta-analysis. [2023]
Comparative evaluation of efficacy and safety of combination of metformin-vidagliptin versus metfromin-glimepiride in most frequently used doses in patients of type 2 diabetes mellitus with inadequately controlled metformin monotherapy-A randomised open label study. [2020]
Fixed-Dose Combination of Dapagliflozin + Sitagliptin + Metformin in Patients with Type 2 Diabetes Poorly Controlled with Metformin: Phase 3, Randomized Comparison with Dual Combinations. [2023]
[Metformin role in the treatment of type 2 diabetes in 2008]. [2013]
A real world comparison of sulfonylurea and insulin vs. incretin-based treatments in patients not controlled on prior metformin monotherapy. [2018]
Metformin: a biguanide. [2013]
Gastrointestinal tolerability of extended-release metformin tablets compared to immediate-release metformin tablets: results of a retrospective cohort study. [2021]
[Cross-Sectional Study on Adverse Effects of Metformin Hydrochloride on 130 Patients Type 2 Diabetic Admitted to Medical Center and Diabetes Home of Sidi Bel-Abbès]. [2023]
Efficacy, dose-response relationship and safety of once-daily extended-release metformin (Glucophage XR) in type 2 diabetic patients with inadequate glycaemic control despite prior treatment with diet and exercise: results from two double-blind, placebo-controlled studies. [2022]
Clinical Effectiveness and Safety of Once-Weekly GLP-1 Receptor Agonist Dulaglutide as Add-On to Metformin or Metformin Plus Insulin Secretagogues in Obesity and Type 2 Diabetes. [2021]
Pharmacological intervention for diabetes after pregnancy prevention in women with prior gestational diabetes: A scoping review. [2020]
The diversity of gestational diabetes: a therapeutic challenge. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Metformin for Preventing Type 2 Diabetes Mellitus in Women with a Previous Diagnosis of Gestational Diabetes: A Narrative Review. [2021]
Preventing progression from gestational diabetes mellitus to diabetes: A thought-filled review. [2018]
Metformin versus insulin treatment in gestational diabetes in pregnancy in a developing country: a randomized control trial. [2018]
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