Efficacy and Safety of the Once-Weekly Basal Insulin LY3209590 Therapy Compared with Daily Insulin Degludec in Adults with Type 2 Diabetes Treated with Basal Insulin

A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared with Insulin Degludec in Participants with Type 2 Diabetes Currently Treated with Basal Insulin (QWINT-3) - QWINT-3

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002569-16-SK

Enrollment

939

Registered

2022-02-22

Start date

2022-05-20

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Interventions

Product Name: LY3209590 Product Code: LY3209590 Pharmaceutical Form: Solution for injection INN or Proposed INN: LY3209590 Other descriptive name: LY3209590 Concentration unit: U/ml unit(s)/millilitre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Must be at least 18 years of age at screening (or older per local regulations) Have a diagnosis of type 2 diabetes according to the WHO criteria currently treated with basal insulin (includes biosimilars) with or without non-insulin diabetes therapy which may include up to 3 of the following: - dipeptidyl peptidase (DPP-4) IV inhibitors - SGLT2 inhibitors - metformin - alpha-glucosidase inhibitors, or - GLP-1 receptor agonists Have HbA1c value 6.5%-10% inclusive Have body mass index (BMI) less than or equal to 45kg/m2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 845 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 94

Exclusion criteria

Exclusion criteria: Have a diagnosis of type 1 diabetes, latent autoimmune diabetes or a specific type of diabetes other than type 2 Have had significant weight gain or loss in the past 3 months Are receiving chronic (>14 days) systemic glucocorticoid therapy Have had New York Heart Association Class IV heart failure or any of the following CV conditions: acute myocardial infarction, cerebrovascular accident (stroke), or coronary bypass surgery have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease Have an eGFR <20 mL/min/1.73m2 Have active or untreated malignancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the hypothesis that LY3209590 is noninferior to the comparator (insulin degludec) on glycemic control in study participants with T2D currently on basal insulin;Secondary Objective: To demonstrate LY3209590 is superior to insulin degludec in the selected parameters of glycemic control;Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: Week 26	—

Measure

Time frame

Main Objective: To investigate the hypothesis that LY3209590 is noninferior to the comparator (insulin degludec) on glycemic control in study participants with T2D currently on basal insulin;Secondary Objective: To demonstrate LY3209590 is superior to insulin degludec in the selected parameters of glycemic control;Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: Week 26

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Secondary

Measure	Time frame
Secondary end point(s): -Change from baseline in HbA1c at Week 26 -The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 mg/dL [3.0 mmol/L] or severe) during treatment phase up to Week 78 -Time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L) inclusive measured during the CGM session prior to Week 26;Timepoint(s) of evaluation of this end point: -Week 26 -Week 78	—

Measure

Time frame

Secondary end point(s): -Change from baseline in HbA1c at Week 26 -The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 mg/dL [3.0 mmol/L] or severe) during treatment phase up to Week 78 -Time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L) inclusive measured during the CGM session prior to Week 26;Timepoint(s) of evaluation of this end point: -Week 26 -Week 78

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Countries

Argentina, Hungary, Japan, Korea, Republic of, Poland, Slovakia, Spain, Taiwan, United States

Contacts

Public ContactClinical Trial Registry Office

Eli Lilly

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026