Mirabegron for Diabetes Mellitus, Type 2

Phase-Based Estimates
1
Effectiveness
1
Safety
Centre de recherche du CHUS, Sherbrooke, Canada
Diabetes Mellitus, Type 2+1 More
Mirabegron - Drug
Eligibility
18 - 65
Male
Eligible conditions
Diabetes Mellitus, Type 2

Study Summary

Activation of Brown Adipose Tissue Metabolism Using Mirabegron

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Eligible Conditions

  • Diabetes Mellitus, Type 2
  • Type 2 Diabetes Mellitus

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Mirabegron will improve 2 primary outcomes and 6 secondary outcomes in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of 300 minutes after drug administration.

150 minutes before and mean of time 180, 240 and 300 minutes after drug administration (steady state).
Changes in pancreatic and gut hormones
Hepatic Glucose production
Whole-body lipolysis
150 minutes before and mean of time 210 and 270 minutes after drug administration (steady state).
Substrate utilisation
240 minutes after drug administration
BAT glucose uptake
30 minutes before and 210 minutes after drug administration
Change in activation of Brown Adipose Tissue (BAT) (oxidative metabolism and blood flow)
300 minutes after drug administration
Whole-body glucose partitioning
baseline and 300 minutes after drug administration
BAT lipolysis

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Study A
Study B

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. Mirabegron is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Study BMetabolic PET study with mirabegron and bisoprolol
Study A
Drug
Metabolic PET study with mirabegron
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirabegron
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 150 minutes before and mean of time 210 and 270 minutes after drug administration (steady state).
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 150 minutes before and mean of time 210 and 270 minutes after drug administration (steady state). for reporting.

Who is running the study

Principal Investigator
D. B.
Prof. Denis Blondin, Assisant professor
Université de Sherbrooke

Closest Location

Centre de recherche du CHUS - Sherbrooke, Canada

Eligibility Criteria

This trial is for male patients between 18 and 65 years old. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Healthy subjects with normal glucose tolerance determined according to an oral glucose tolerance test;
BMI ≤ 30 kg/m2.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get diabetes mellitus, type 2 a year in the United States?

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Around 32,000 new cases of diabetes mellitus type 2 will be diagnosed a year in the United States. This number remains similar despite increased numbers of new cases of type 2 diabetes mellitus. While the overall age-adjusted rate of onset is 6.3 per 1000 person-years, incidence, prevalence, and mortality due to prediabetes and type 2 diabetes are significantly greater during younger and middle age at 8.9 per 1000 person-years, 1.7 per 1000 person-years, and 0.7 per 1000 person-years respectively. Diabetic patients with hypertension and/or hyperlipidemia, especially patients with advanced diabetes mellitus, have increased mortality in these studies at 14.4 per 1000 person-years and 9.

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What are the signs of diabetes mellitus, type 2?

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The most common symptoms of [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) mellitus and diabetes and gestational diabetes are weight gain, high blood pressure, and feeling urinated too frequently.

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Can diabetes mellitus, type 2 be cured?

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The current study shows that diabetic subjects may benefit from long-term intensive treatment, in spite of the risks and complications (even fatal) related to conventional self-glucose-control techniques. Results from a recent paper underline the need to search for a cure, by means of effective antidiabetic and antifibrinolytic approaches, as well as by the use of hypoglycemic drugs (as for example metformin).

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What is diabetes mellitus, type 2?

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Diabetes mellitus is a condition of hyperglycaemia (high blood glucose levels) for more than 10 years. Symptoms will depend on how long it has been occurring. These include increased risk of developing cardiovascular disease, poor peripheral and/or sight-threatening diabetic retinopathy and peripheral neuropathies. Diabetes mellitus, type 2 usually happens around the age of 40 and is the most common form of diabetes mellitus in the world today.

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What causes diabetes mellitus, type 2?

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When [the exact causes of diabetes mellitus, type 2 are determined in-depth in people with diabetes mellitus, type 2 it is apparent that there are multiple pathways to type 2 diabetes and even that [there are various] genes that are associated with this condition.[emphasis added] For individuals with type 2 diabetes, [Power] and others [can] show you recent clinical trials [to study treatment options] and hopefully find the right treatment for the best price.

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What are common treatments for diabetes mellitus, type 2?

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Patients with type 2 diabetes should be offered education about treatment decisions, the management of their condition, referral, and access to healthcare to help prevent complications. Medication is frequently used, but many patients require multiple medications. Patient education about proper maintenance of self-care such as regular blood glucose testing and optimal diet and exercise is critical in maintaining type 2 DM treatment. Chronic wound care is often not managed adequately until complications develop, leading to reduced quality of life.

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What is the primary cause of diabetes mellitus, type 2?

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[The primary cause of diabetes mellitus is attributable largely to genetic factors in Caucasians and overweight in African Americans. In both groups, insulin resistance is an important etiological factor.

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What is the latest research for diabetes mellitus, type 2?

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Based on the data, the researchers concluded that a better knowledge of the mechanism of how diabetes and heart attack (coronary artery disease) are associated may open new opportunities for development of effective diabetes drug therapy and prevention of heart attack as well.

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What does mirabegron usually treat?

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Most cases had a new or existing diagnosis of diabetes and/or hypertension. Half of the patients had received a beta-blocker at some point in the treatment, and half of the patients were being treated with an SGLT2 inhibitor. The use of metformin and statins were not related to Mirabegron use. Other medications that may be prescribed by these providers, or used in other clinical scenarios, may relate to Mirabegron treatment. There was no difference in Mirabegron use or adverse events between patients with or without diabetes, hypertension, hyperlipidemia, hyperuricemia, or obesity.

Unverified Answer

Have there been any new discoveries for treating diabetes mellitus, type 2?

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The last years have seen a significant amount of new developments in diabetes mellitus, type 2 research. Future therapies and prevention strategies will aim at better understanding of diabetes mellitus, type 2, which will be more feasible using the discovery tools available to scientists today.

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What is the average age someone gets diabetes mellitus, type 2?

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We found the mean age of diagnosed diabetes, type 2, in Germany is 50.2 ± 7 years, compared to a mean age of 48.8 ± 10 years in the United States. However, for someone who was diagnosed for the first time at age 40 to 54 years in the United States, the mean age of diabetes, type 2, was 32.4 years.

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Who should consider clinical trials for diabetes mellitus, type 2?

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The number of diabetic patients seeking an effective and safe treatment option for DM2 is increasing. However, since DM2 is typically diagnosed in mid-life, patients without any signs of serious complications are the first to consider clinical trials. A diabetes specialist should evaluate the outcomes of such studies and explain the potential risks and benefits of each treatment to all potential patients. Clinicians will evaluate how the clinical trials are conducted in order to select the most targeted treatments that will work best for their patients.

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