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Insulin Efsitora Alfa for Type 2 Diabetes

University of Colorado Anschutz Medical Campus, Aurora, CO
Type 2 Diabetes+1 More ConditionsInsulin Efsitora Alfa - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety and effectiveness of a new type 2 diabetes medication vs. insulin glargine.

Eligible Conditions
  • Type 2 Diabetes

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

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Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Week 52

Baseline, Week 52
Change from Baseline in Body Weight
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) in Overall Treatment Satisfaction
Change from Baseline in Fasting Glucose
Change from Baseline in HbA1c
Change from Baseline in Hemoglobin A1c (HbA1c)
Change from Baseline in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics
Change from Baseline in Treatment Experience in Simplicity of Diabetes Treatment Questionnaire (SIM-Q) in Overall Simplicity and Complexity
Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)
Week 52
Level 2 and 3 Hypoglycemia Event Rate of Composite and Incidence
Level 2 and 3 Nocturnal Hypoglycemia Event Rate of Composite and Incidence

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
LY3457263
1
Glucagon Nasal Powder [Baqsimi]
1
Lyumjev

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3 Treatment Groups

Insulin Glargine
1 of 3
Insulin Efsitora Alfa
1 of 3
LY3209590
1 of 3

Active Control

Experimental Treatment

670 Total Participants · 3 Treatment Groups

Primary Treatment: Insulin Efsitora Alfa · No Placebo Group · Phase 3

Insulin Efsitora Alfa
Drug
Experimental Group · 1 Intervention: Insulin Efsitora Alfa · Intervention Types: Drug
LY3209590
Drug
Experimental Group · 1 Intervention: LY3209590 · Intervention Types: Drug
Insulin Glargine
Drug
ActiveComparator Group · 1 Intervention: Insulin Glargine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3209590
2018
Completed Phase 2
~1260

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 52

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,499 Previous Clinical Trials
3,154,685 Total Patients Enrolled
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,280 Previous Clinical Trials
381,135 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
Missouri50.0%
Texas50.0%
What site did they apply to?
Clinvest Research LLC50.0%
Endocrine Associates50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "Getting my blood under control and possibly getting paid"
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

Have any regulatory bodies granted authorization for LY3209590?

"Our team at Power rates the safety of LY3209590 a 3 on the scale due to this being a Phase 3 trial, with both evidence backing its efficacy and multiple verifications confirming its security." - Anonymous Online Contributor

Unverified Answer

How many distinct sites are overseeing this clinical trial?

"Syed Research Consultants Llc in Sheffield, AMCR Institute in Escondido and Velocity Clinical Research, Gardena in Gardena are just three of the 40 sites currently partaking in this medical study." - Anonymous Online Contributor

Unverified Answer

Are new participants currently being accepted for this research study?

"At present, clinicaltrials.gov signals that recruitment for this study has concluded. This trial was first posted on January 16th 2023 and last updated on December 21st 2022, however there are still 1474 other trials recruiting patients at the current moment in time." - Anonymous Online Contributor

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

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