LY3209590 for Type 2 Diabetes

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Type 2 DiabetesLY3209590 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is to see if LY3209590 is a safe and effective treatment for Type 2 diabetes in patients who are already taking basal insulin. The study will last up to 86 weeks and will involve a 3-week screening period, a 78-week treatment period, and a 5-week safety follow-up period.

Eligible Conditions
  • Type 2 Diabetes

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Week 22 to Week 26

Baseline to Week 78
Level 2 or Level 3 Nocturnal Hypoglycemia Event Rate
Nocturnal Hypoglycemia Event Rate
Baseline, Week 26
Change from Baseline in Fasting Glucose
Change from Baseline in Hemoglobin A1c (HbA1c)
Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)
Baseline, Week 78
Change from Baseline in Body Weight
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ)
Week 26
Time in Hyperglycemia Range
Time in Hypoglycemia Range
Time in Range
Week 26
Weekly Insulin dose

Trial Safety

Safety Progress

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

Side Effects for

LY3209590 Algorithm 2 (Digital)
6%Hepatic enzyme increased
6%Nasal congestion
6%Hypertension
6%Onychomycosis
6%Sars-cov-2 test positive
6%Injection site bruising
6%Sinusitis
6%Covid-19
6%Nasopharyngitis
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT04450407) in the LY3209590 Algorithm 2 (Digital) ARM group. Side effects include: Hepatic enzyme increased with 6%, Nasal congestion with 6%, Hypertension with 6%, Onychomycosis with 6%, Sars-cov-2 test positive with 6%.

Trial Design

2 Treatment Groups

Insulin Degludec
1 of 2
LY3209590
1 of 2

Active Control

Experimental Treatment

1228 Total Participants · 2 Treatment Groups

Primary Treatment: LY3209590 · No Placebo Group · Phase 3

LY3209590
Drug
Experimental Group · 1 Intervention: LY3209590 · Intervention Types: Drug
Insulin Degludec
Drug
ActiveComparator Group · 1 Intervention: Insulin Degludec · 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 22 to week 26

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,465 Previous Clinical Trials
3,134,157 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
1,257 Previous Clinical Trials
368,140 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin.
You have a HbA1c value of 6.5% - 10% inclusive, at screening.
You have been taking insulin degludec once daily for more than 3 months.
The patient must be on insulin glargine once daily.
You have been treated with insulin detemir or human insulin NPH for at least 3 months.
You are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening.
You have a BMI less than or equal to 45 kg/m².

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Gadolin Research50.0%
Juno Research50.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
How many prior treatments have patients received?
0100.0%