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GLP-1 RA agonist
Tirzepatide for Type 2 Diabetes
Phase 4
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment 12 weeks
Follow Up baseline, week 12
Awards & highlights
Study Summary
This trial studies effects of switching T2D meds to see if they help manage blood sugar better.
Eligible Conditions
- Type 2 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ 12 weeks4 visits
Follow Up ~ baseline, week 12
Screening ~ 3 weeks
Treatment ~ 12 weeks
Follow Up ~baseline, week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Hemoglobin A1c (HbA1c)
Secondary outcome measures
Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values are >180 mg/dl (10 mmol/L)
Change from Baseline in Fasting Serum Glucose (FSG)
Change from Baseline in Percentage of Time per Day that Continuous Glucose Monitoring (CGM)-derived Values are >180 mg/dl (10 mmol/L)
+2 moreSide effects data
From 2022 Phase 3 trial • 210 Patients • NCT0502403240%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Gastroenteritis
11%
Vomiting
9%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: TirzepatideExperimental Treatment1 Intervention
Participants will receive tirzepatide subcutaneously (SC).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7590
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,615 Previous Clinical Trials
3,200,908 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,102 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a high risk of heart disease or have had a heart attack, surgery to clear blocked blood vessels, a stroke, or hospitalization for heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Tirzepatide
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05706506 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration authorized Tirzepatide for public use?
"Our analysis at Power appraised the safety of Tirzepatide as 3, which is the highest score attainable due to its status in Phase 4 trials and official approval."
Answered by AI
At how many distinct sites is this experiment being conducted?
"There are 35 trial sites currently in operation, such as Family Care Associates of Burlingame, New Hope Research Development in Corona and Velocity Clinical Research Gardena."
Answered by AI
Are there any vacancies in the current clinical trial that need to be filled?
"Clinicaltrials.gov data suggests that recruitment for this clinical trial is still underway, having first been posted on March 8th 2023 and last updated two weeks later."
Answered by AI
What is the total cohort size of this experiment?
"Affirmative. According to the data found on clinicaltrials.gov, this medical trial is actively searching for participants. The study was initially announced on March 8th 2023 and has been updated as recently as March 24th of that year. 150 individuals are required from 35 distinct sites for enrollment into the program."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Missouri
Georgia
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Georgia Clinical Research
Endocrine Research Solutions, Inc.
Clinical Research Professionals
Other
How many prior treatments have patients received?
1
2
3+
0
Why did patients apply to this trial?
looking to my A1C below 6 if posable and loose some weight. I am willing to try different medications to help manage my diabetes.
PatientReceived 1 prior treatment
I want to help find better treatments and to try to Kickstart my control. I’ve tried 3 different types of medications and I don’t feel any different.
PatientReceived no prior treatments
I've tried a few meds, would like to find one that has greater effectiveness.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Can this be done if I am traveling? What are the hours for the appointments?
PatientReceived 2+ prior treatments
How long is screening take for the process? Where are you located at? How long is the trial? How many times will I have to visit the clinic?
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- Georgia Clinical Research: < 24 hours
- Velocity Clinical Research, Hallandale Beach: < 48 hours
- Clinical Research Professionals: < 48 hours
Typically responds via
Email
Phone Call
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