LY3209590 for Diabetes Mellitus

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
NBR Polska, Warszawa, Poland
Diabetes Mellitus+3 More
LY3209590 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The main purpose of this study is to measure the safety and efficacy of LY3209590 compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.

Eligible Conditions

  • Diabetes Mellitus
  • Type 1 Diabetes Mellitus
  • Diabetes

Treatment Effectiveness

Effectiveness Progress

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

Other trials for Diabetes Mellitus

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: Week 22 to Week 26

Baseline to Week 52
Nocturnal Hypoglycemia Event Rate
Rate of Composite Level 2 and 3 Hypoglycemia Events
Baseline, Week 26
Change from Baseline in Body Weight
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ)
Change from Baseline in Fasting Glucose
Change from Baseline in Hemoglobin A1c (HbA1c)
Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Acute Form Domain Scores
Week 26
Glucose Variability
Time in Glucose Range
Time in Hyperglycemia Range
Time in Hypoglycemia Range
Week 26
Basal Insulin Dose
Bolus Insulin Dose
Total Insulin Dose

Trial Safety

Safety Progress

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

Other trials for 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

670 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 22 to week 26
Closest Location: Dallas Diabetes Research Center · Dallas, TX
Photo of Dallas  1Photo of Dallas  2Photo of Dallas  3
2021First Recorded Clinical Trial
17 TrialsResearching Diabetes Mellitus
11 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening.
You have a body mass index of ≤35 kg/m².
You have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening.
You have an HbA1c value of 7.0% to 10.

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.