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
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
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
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: DrugInsulin Degludec
Drug
ActiveComparator Group · 1 Intervention: Insulin Degludec · Intervention Types: DrugTreatment
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?
| Texas | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Gadolin Research | 50.0% |
| Juno Research | 50.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
How many prior treatments have patients received?
| 0 | 100.0% |
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Conditions
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