Mirabegron for Prediabetes

Overseen By Philip Kern, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Philip Kern

Must not be taking: Anti-diabetic medications

Disqualifiers: Diabetes, Cancer, Renal insufficiency, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

65 Participants Needed

Trial Summary

What is the purpose of this trial?

Mirabegron (Myrbetriq®, Astellas) is a highly specific and well-tolerated ß3 agonist marketed for overactive bladder. This trial will assess the effects of mirabegron on glucose tolerance and adipose tissue in prediabetic patients

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on chronic anti-diabetic medication, you would not be eligible to participate.

Is Mirabegron safe for human use?

Mirabegron has been studied for the treatment of overactive bladder in several large clinical trials, which included safety evaluations. These studies found that Mirabegron is generally safe for human use at doses of 25 mg, 50 mg, and 100 mg. ^{1 2 3 4 5}

How is the drug Mirabegron unique for prediabetes?

Mirabegron is unique for prediabetes because it is primarily used to treat overactive bladder by relaxing bladder muscles, and its use for prediabetes is novel, as there are no standard treatments specifically for prediabetes. This makes its mechanism of action different from typical diabetes medications, which usually focus on insulin regulation. ^{6 7 8 9 10}

Research Team

Philip Kern, MD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for adults with prediabetes, characterized by slightly elevated blood sugar levels. Participants should have a BMI between 27-45 and not be on any chronic anti-diabetic medications. Those with kidney issues, cancer, unstable health conditions, inflammation or specific contraindications to Mirabegron cannot join.

Inclusion Criteria

You have a condition where your blood sugar levels are higher than normal, but not high enough for a diabetes diagnosis.

Your body mass index (BMI) is between 27 and 45.

You have difficulty with fasting or have trouble processing glucose.

Exclusion Criteria

My kidneys do not work well.

I have an ongoing inflammation condition.

My BMI is over 45.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mirabegron or placebo for 16 weeks to assess effects on glucose metabolism and adipose tissue

16 weeks

2 visits (baseline and 16 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mirabegron
• Placebo

Trial Overview The study is testing the effects of Mirabegron (a medication used for overactive bladder) on improving blood sugar control and fat tissue function in people with prediabetes compared to a placebo.

Participant Groups

Group I: Mirabegron Experimental Treatment 1 Intervention

Participants in this group will receive Mirabegron for 16 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants in the group will receive placebo.

Mirabegron is already approved in United States, European Union for the following indications:

Approved in United States as Myrbetriq for:

• Overactive bladder (OAB)
• Neurogenic detrusor overactivity (NDO)

Approved in European Union as Mirabegron for:

• Overactive bladder (OAB)
• Neurogenic detrusor overactivity (NDO)

Who Is Running the Clinical Trial?

Philip Kern

Lead Sponsor

Trials

8

Recruited

450+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Mirabegron (50 and 100 mg) significantly improved symptoms of overactive bladder compared to placebo in a pooled analysis of three 12-week studies involving large patient groups, showing effectiveness in reducing incontinence episodes and micturitions.

The safety profile of mirabegron is favorable, with common side effects like hypertension and urinary tract infections decreasing at higher doses, and it has a lower incidence of dry mouth compared to the standard treatment, tolterodine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirabegron for the treatment of overactive bladder: a prespecified pooled efficacy analysis and pooled safety analysis of three randomised, double-blind, placebo-controlled, phase III studies. Nitti, VW., Khullar, V., van Kerrebroeck, P., et al.[2022]

This issue of Gateways to Clinical Trials provides a comprehensive overview of recent clinical trials involving a wide range of drugs, highlighting the importance of staying updated on new treatments and their efficacy.

The drugs listed, including well-known medications like adalimumab and bevacizumab, represent various therapeutic areas, indicating ongoing research and development in the field of medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gateways to clinical trials. Bayés, M., Rabasseda, X., Prous, JR.[2014]

The document serves as a comprehensive guide to recent clinical trials involving a wide range of drugs, indicating a focus on the latest advancements in drug discovery and development.

It highlights various drugs, including agomelatine and others, suggesting ongoing research and potential therapeutic options across multiple medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gateways to clinical trials. Bayes, M., Rabasseda, X., Prous, JR.[2007]

The document provides a comprehensive overview of recent clinical trials for a wide range of drugs, including well-known medications like adalimumab and aripiprazole, indicating ongoing research and development in various therapeutic areas.

It highlights the importance of clinical trials in evaluating the safety and efficacy of new treatments, showcasing a diverse selection of drugs that are currently being tested for their potential benefits in treating different health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gateways to clinical trials. Bayés, M., Rabasseda, X., Prous, JR.[2007]

Metformin is the first-line treatment for type 2 diabetes and has been shown to have cardio-protective effects, making it a safe choice for patients with cardiovascular disease.

For patients with cardiovascular disease who need a second-line treatment, medications like empagliflozin, liraglutide, and semaglutide are recommended, while sulfonylureas (except gliclazide) should generally be avoided due to unclear cardiovascular safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on Cardiovascular Effects of Older and Newer Anti-diabetic Medications. Eleftheriadou, I., Grigoropoulou, P., Liberopoulos, E., et al.[2019]

In a study of 858 insulin-naive participants with type 2 diabetes, both insulin glargine 300 U/ml (IGlar-300) and 100 U/ml (IGlar-100) effectively reduced HbA1c and fasting plasma glucose levels in the Mild Age-Related Diabetes (MARD) and Mild Obesity Diabetes (MOD) subphenotypes after 26 weeks.

However, in the Severe Insulin Deficient Diabetes (SIDD) group, IGlar-100 was more effective than IGlar-300 in lowering HbA1c and fasting plasma glucose, and IGlar-300 was associated with a lower incidence of nocturnal hypoglycemia, indicating a potential safety advantage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment responses to basal insulin glargine 300 U/ml and glargine 100 U/ml in newly defined subphenotypes of type 2 diabetes: A post hoc analysis of the EDITION 3 randomized clinical trial. Landgraf, W., Owens, DR., Frier, BM., et al.[2023]

In a study of 186 patients with type 2 diabetes, those switched to the insulin degludec/liraglutide (iDegLira) combination achieved a greater reduction in HbA1c levels, with 22% reaching HbA1c < 7% compared to 18.2% in the insulin glargine/lixisenatide (iGlarLixi) group after 6 months.

Patients using iDegLira also experienced significant weight loss (1.8 kg) compared to those on iGlarLixi (0.7 kg), while both groups showed similar effects on fasting and postprandial glucose levels and lipid profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct comparison two fixed-ratio combination glucagon-like peptide receptor agonist and basal insulin on glycemic and non glycemic parameters in type 2 diabetes. Risovic, I., Dumanovic, MS., Bojic, M., et al.[2023]

The study involved 887 adults with type 2 diabetes (T2D) who were inadequately controlled on basal insulin, comparing the efficacy and safety of iGlarLixi (a combination of insulin glargine and lixisenatide) to premix insulin (BIAsp 30) over 26 weeks.

iGlarLixi demonstrated improved HbA1c reductions with a similar risk of hypoglycemia and more favorable body weight outcomes compared to BIAsp 30, suggesting it may be a better option for treatment intensification in T2D patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing therapy with iGlarLixi versus premix BIAsp 30 in basal insulin-treated type 2 diabetes: Design and baseline characteristics of the SoliMix randomized controlled trial. McCrimmon, RJ., Al Sifri, S., Emral, R., et al.[2022]

In a study of 199 patients with type 1 diabetes who switched to either insulin glargine 300 U/ml (Gla-300) or insulin degludec 100 U/ml (IDeg-100), both insulins showed similar overall time in range (TIR) for glucose levels, indicating comparable effectiveness in managing blood sugar during the day.

However, Gla-300 demonstrated a significantly better nocturnal glucose profile, with higher TIR at night and lower time spent above the target range compared to IDeg-100, suggesting it may offer advantages for nighttime glucose control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Insulin Glargine 300 U/ml in Comparison with Insulin Degludec 100 U/ml Evaluated with Continuous Glucose Monitoring in Adults with Type 1 Diabetes and Suboptimal Glycemic Control in Routine Clinical Practice: The OneCARE Study. Conget, I., Mangas, MÁ., Morales, C., et al.[2021]

LixiLan (iGlarLixi) significantly reduced HbA1c levels more than insulin glargine (iGlar) in patients with type 2 diabetes, achieving a mean final HbA1c of 6.9% compared to 7.5% for iGlar, with 55% of iGlarLixi patients reaching the target of HbA1c <7.0%.

Patients using iGlarLixi experienced a decrease in body weight, while those on iGlar gained weight, with no increased risk of hypoglycemia and only mild gastrointestinal side effects, indicating a favorable safety and efficacy profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial. Aroda, VR., Rosenstock, J., Wysham, C., et al.[2022]

References

1. India pubmed.ncbi.nlm.nih.gov

Mirabegron for the treatment of overactive bladder: a prespecified pooled efficacy analysis and pooled safety analysis of three randomised, double-blind, placebo-controlled, phase III studies. [2022]

2. Spain pubmed.ncbi.nlm.nih.gov

Gateways to clinical trials. [2014]

3. Spain pubmed.ncbi.nlm.nih.gov

Gateways to clinical trials. [2007]

4. Spain pubmed.ncbi.nlm.nih.gov

Gateways to clinical trials. [2007]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Update on Cardiovascular Effects of Older and Newer Anti-diabetic Medications. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Treatment responses to basal insulin glargine 300 U/ml and glargine 100 U/ml in newly defined subphenotypes of type 2 diabetes: A post hoc analysis of the EDITION 3 randomized clinical trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Direct comparison two fixed-ratio combination glucagon-like peptide receptor agonist and basal insulin on glycemic and non glycemic parameters in type 2 diabetes. [2023]

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

Advancing therapy with iGlarLixi versus premix BIAsp 30 in basal insulin-treated type 2 diabetes: Design and baseline characteristics of the SoliMix randomized controlled trial. [2022]

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

Effectiveness and Safety of Insulin Glargine 300 U/ml in Comparison with Insulin Degludec 100 U/ml Evaluated with Continuous Glucose Monitoring in Adults with Type 1 Diabetes and Suboptimal Glycemic Control in Routine Clinical Practice: The OneCARE Study. [2021]

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

Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial. [2022]