What this study is
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
What's being tested
- Placebo
Intervention · DRUG
Participants will take one pill (placebo) daily for the first week and two pills daily for the remaining 15 weeks.
- Mirabegron
Intervention · DRUG
Participants will take one pill (50mg Mirabegron) daily for the first week. For week two, participants will take two pills (50mg and 25mg Mirabegron). Unless there are side effects, for the remaining 14 weeks participants will take two pills (50mg each) daily.
- Mirabegron 50 MG
Intervention · DRUG
Participants will take one pill (50mg Mirabegron) daily between visit 2 and visit 3
- Mirabegron 100 mg
Intervention · DRUG
participants will be given 6 weeks of mirabegron (25 mg) and will take 1 pill once per day for 4-6 weeks. Next participants will be given 6 weeks of mirabegron (50 mg) and take 1 pill once per day for 4-6 weeks. Last participants will be given 6 weeks of mirabegron (100 mg) and take 1 pill once per day for 4-6 weeks.
Study details
- Sponsor
- Philip Kern
- Conditions
- PreDiabetes
- Enrolling
- 65 people
- Starts
- 2020-12-07
- Est. completion
- 2027-12
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 35 Years – 65 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- BMI 27-45
- Prediabetes (A1c 5.7-6.4)
- Impaired fasting glucose or impaired glucose tolerance
You can't join if
- Diabetes
- Chronic use of anti-diabetic medication
- Acute or chronic inflammatory condition
- Unstable medical condition
- Cancer
- Renal insufficiency
- Any contraindication for Mirabegron
- BMI >45
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Kentucky
Lexington, Kentucky, United States
- Zach Leicht · Contact859-218-1397zachary.leicht@uky.edu
- Philip Kern, MD · Principal investigator
Recruiting
Study team
Sponsor
Philip Kern
Study ID 60821
Principal investigator
Philip Kern, MD
University of Kentucky
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.