65 Participants Needed

Mirabegron for Prediabetes

PK
Overseen ByPhilip Kern, MD
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

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.678910

Research Team

PK

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.
See 5 more

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 OverviewThe 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MirabegronExperimental Treatment1 Intervention
Participants in this group will receive Mirabegron for 16 weeks.
Group II: PlaceboPlacebo Group1 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)

Find a Clinic Near You

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

References

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]
Gateways to clinical trials. [2014]
Gateways to clinical trials. [2007]
Gateways to clinical trials. [2007]
5.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Update on Cardiovascular Effects of Older and Newer Anti-diabetic Medications. [2019]
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]
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]
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]
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 Statespubmed.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]