Metformin for Vitiligo

Overseen By Nuria Martinez Gutierrez, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Massachusetts, Worcester

Must not be taking: Oral corticosteroids, Topical steroids

Disqualifiers: Active vitiligo, Pregnancy, Diabetes, 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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

Trial Summary

What is the purpose of this trial?

This trial tests metformin, a diabetes drug, on people with stable vitiligo. The drug may help restore color to the skin by reducing the activity of specific immune cells.

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

The trial requires that you stop taking systemic immunosuppressive medications (like oral corticosteroids) at least 4 weeks before joining, and topical steroids at least 2 weeks before. You also cannot use certain prescription medications or cosmetics that might affect healing, such as retinoids or glycolic acid.

Is Metformin safe for humans?

Metformin is generally considered safe for humans when used as directed, with common side effects including stomach issues and a rare risk of lactic acidosis (a buildup of lactic acid in the body). It is important to monitor kidney and liver function while using it. ^{1 2 3 4 5}

How does the drug Metformin differ from other treatments for vitiligo?

Metformin is primarily known as a treatment for type 2 diabetes, where it helps control blood sugar levels. Its use for vitiligo is novel because it is not traditionally associated with skin conditions, and there are no standard treatments for vitiligo that involve Metformin. This makes its application in vitiligo unique, as it may offer a new approach to managing this condition. ^{3 6 7 8 9}

Research Team

John E Harris, MD, PhD

Principal Investigator

Chair, Department of Dermatology

Eligibility Criteria

This trial is for adults over 18 with stable vitiligo, which means no new or expanding spots for a year. Participants must be willing to undergo suction blistering and have not used certain skin treatments recently. It's not for pregnant women, those on systemic immunosuppressants, UVB therapy patients, or individuals with diabetes, liver/kidney disease.

Inclusion Criteria

Informed consent document signed by the subject

Non-English speaking adults may be enrolled with the assistance of an interpreter and the use of an IRB-approved short form in the subject's language

I am an adult with stable vitiligo.

Exclusion Criteria

Any other health issue or test result that, according to the experts, might affect how you respond to the treatment or the accuracy of the study results, or might be risky for you.

I use products that may affect healing, but I can bring them for review.

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral metformin starting at 500 mg twice daily, potentially increasing to 1000 mg twice daily if tolerated

24 weeks

Regular follow-up visits to monitor symptoms and adjust dosage

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Metformin Hydrochloride

Trial Overview The trial tests if Metformin Hydrochloride can treat vitiligo by changing the metabolism of specific immune cells (CD8+ T cells) to reduce their harmful activity. The study involves taking oral metformin and monitoring its effects on the skin condition.

Participant Groups

Group I: Oral Metformin Experimental Treatment 1 Intervention

Treatment with metformin will be started at 500 mg twice daily and increased to 1000 mg twice daily only after they have tolerated the treatment.

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

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Findings from Research

In a study of 130 patients with type 2 diabetes treated with Metformin Hydrochloride, gastrointestinal adverse effects were the most common, with diarrhea affecting 30.77% of patients and leading to treatment discontinuation in 3.85%.

No cases of serious complications like lactic acidosis or allergic reactions were reported, indicating that while Metformin is generally safe, monitoring for digestive issues is important in managing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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]. Sakouhi, M., Matmour, D., Belakhdar, K., et al.[2023]

Metformin remains the first-choice glucose-lowering drug for type 2 diabetes, as other alternatives like sulphonylureas and gliptins have significant adverse effects and lack proven efficacy in preventing diabetes complications.

Many alternative medications, such as sulphonylureas and gliptins, not only lower HbA1c levels modestly but also carry risks of serious side effects, including hypoglycemia, cardiovascular issues, and potential cancer risks, making them less favorable options for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucose-lowering treatment of type 2 diabetes. Part II--Glucose-lowering drugs after metformin: a choice based largely on adverse effects. [2022]

Biguanides and sulfonylureas, introduced in the 1950s, remain widely used for diabetes management, with well-defined safety and tolerability profiles, while newer agents like thiazolidinediones have raised concerns about potential side effects such as heart failure and hepatotoxicity.

Rapid-acting non-sulfonylurea secretagogues may offer a safer alternative for certain patients, particularly those with renal impairment, and alpha-glucosidase inhibitors like acarbose have a strong safety record, although their use is limited by tolerability issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative safety of newer oral antidiabetic drugs. Krentz, AJ.[2022]

Metformin is an effective oral medication for treating non-insulin-dependent diabetes mellitus (type II diabetes) and does not cause hypoglycemia, which is a common side effect of other diabetes medications like sulfonylureas.

The drug is considered safe when proper precautions are taken, including monitoring liver and kidney function, and it has gained widespread use internationally, recently receiving FDA approval under the brand name Glucophage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metformin: a biguanide. Tanja, JJ., Langlass, TM.[2013]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a 24-week study involving 318 patients with type 2 diabetes, adding vildagliptin to a treatment regimen of metformin and glimepiride significantly improved glycaemic control, reducing HbA1c by an average of 1.01% compared to only 0.25% with placebo.

Vildagliptin was well tolerated, showing a low incidence of hypoglycaemia (5.1% vs. 1.9% for placebo) and no significant weight gain, making it a promising option for patients not achieving glycaemic goals with their current medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea. Lukashevich, V., Del Prato, S., Araga, M., et al.[2022]

References

1. France pubmed.ncbi.nlm.nih.gov

[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]

2. England pubmed.ncbi.nlm.nih.gov

Metformin hydrochloride: an antihyperglycemic agent. [2019]

3. France pubmed.ncbi.nlm.nih.gov

Glucose-lowering treatment of type 2 diabetes. Part II--Glucose-lowering drugs after metformin: a choice based largely on adverse effects. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Comparative safety of newer oral antidiabetic drugs. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Metformin: a biguanide. [2013]

6. India pubmed.ncbi.nlm.nih.gov

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]

7. United States pubmed.ncbi.nlm.nih.gov

Metforminium Decavanadate as a Potential Metallopharmaceutical Drug for the Treatment of Diabetes Mellitus. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Real-life effectiveness and tolerability of vildagliptin and other oral glucose-lowering therapies in patients with type 2 diabetes in Germany. [2021]