LY3209590 for Type 2 Diabetes Mellitus

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Medical Corporation Sato Medical clinic, Ōtake, Japan
Type 2 Diabetes Mellitus+3 More
LY3209590 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to determine the effect and safety of LY3209590 compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. Additional participants will continue to be enrolled in a maximum extended enrollment cohort.

Eligible Conditions

  • Type 2 Diabetes Mellitus
  • Diabetes

Treatment Effectiveness

Effectiveness Progress

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

Other trials for Type 2 Diabetes Mellitus

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Week 48 to Week 52

Baseline to Week 52
Level 2 or Level 3 Nocturnal Hypoglycemia Events
Baseline, Week 52
Change from Baseline in Body Weight
Change from Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L)
Change from Baseline in Fasting Glucose
Change from Baseline in HbA1c
Change from Baseline in Hemoglobin A1c (HbA1c)
Change from Baseline in Short Form-36 Version 2 Health Survey Acute Form (SF-36)
Change from Baseline in Treatment-Related IMPACT Measures-Diabetes (TRIM-D)
Weekly Insulin Dose
Week 52
Time in Glucose Range
Time in Hyperglycemia range with glucose >180 mg/dL
Time in hypoglycemia range with glucose <54 mg/dL

Trial Safety

Safety Progress

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

Other trials for Type 2 Diabetes Mellitus

Side Effects for

LY3209590 Algorithm 2
11%Upper respiratory tract infection
6%Diarrhoea
5%Dizziness
4%Cough
2%Hypoglycaemia
1%Chronic obstructive pulmonary disease
1%Dehydration
1%Pneumonia
1%Hypertensive emergency
1%Pancreatitis acute
1%Sepsis
1%Chronic gastritis
1%Osteomyelitis
1%Chest pain
1%Nausea
1%Vomiting
1%Cholelithiasis
0%Syncope
0%Transitional cell carcinoma
0%Arteriosclerosis
0%Diabetic foot
0%Meningitis viral
0%Acute myocardial infarction
0%Femur fracture
0%Ischaemic stroke
0%Osteoarthritis
0%Breast cancer
0%Non-cardiac chest pain
0%Mental status changes
0%Psoas abscess
0%Abscess limb
0%Cellulitis
0%Metastatic neoplasm
0%Sudden cardiac death
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03736785) in the LY3209590 Algorithm 2 ARM group. Side effects include: Upper respiratory tract infection with 11%, Diarrhoea with 6%, Dizziness with 5%, Cough with 4%, Hypoglycaemia with 2%.

Trial Design

2 Treatment Groups

Insulin Degludec
1 of 2
LY3209590
1 of 2
Active Control
Experimental Treatment

912 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
~1210

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 48 to week 52
Closest Location: LMC Clinical Research Inc. (Oakville) · Oakville, Canada
Photo of ontario 1Photo of ontario 2Photo of ontario 3
2017First Recorded Clinical Trial
3 TrialsResearching Type 2 Diabetes Mellitus
5 CompletedClinical Trials

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,428 Previous Clinical Trials
3,117,332 Total Patients Enrolled
127 Trials studying Type 2 Diabetes Mellitus
87,951 Patients Enrolled for Type 2 Diabetes Mellitus
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
1,231 Previous Clinical Trials
363,947 Total Patients Enrolled
51 Trials studying Type 2 Diabetes Mellitus
37,318 Patients Enrolled for Type 2 Diabetes Mellitus

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of type 2 diabetes according to the World Health Organization criteria.
You have an HbA1c of 7.0% - 10% inclusive, at screening.
You are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.