Phase 3
N=795
A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)
Type 2 Diabetes · T2D
Bottom Line
View on ClinicalTrials.gov: NCT05662332 ↗Enrolled (actual)
795
Serious AEs
5.9%
Results posted
Aug 2025
Primary outcome: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority Analysis] — -1.19; -1.16 Percentage of HbA1c
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Insulin Efsitora Alfa (Drug); Insulin Glargine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority Analysis] |
-1.19; -1.16 | — |
| SECONDARY Change From Baseline in HbA1c [Superiority] |
-1.19; -1.16 | 0.684 |
| SECONDARY Change From Baseline in Fasting Glucose |
-46.76; -50.92 | 0.155 |
| SECONDARY Basal Insulin Dose at Week 52 |
289.1; 332.8 | <0.001 sig |
| SECONDARY Rate Per Year of Hypoglycemia Events |
0.50; 0.88 | 0.005 sig |
| SECONDARY Percentage of Participants With Hypoglycemia Events (Incidence) |
25.94; 29.90 | — |
| SECONDARY Rate Per Year of Nocturnal Hypoglycemia Events |
0.05; 0.08 | 0.155 |
| SECONDARY Percentage of Participants With Nocturnal Hypoglycemia Events (Incidence) |
3.53; 5.03 | — |
| SECONDARY Change From Baseline in Body Weight |
3.86; 3.29 | 0.033 sig |
| SECONDARY Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) Total Score |
15.4; 13.87 | 0.071 |
| SECONDARY Change From Baseline in Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQ-c) |
-1.2; -1.3; -1.0; -0.9; 15.1; 14.5 | — |
| SECONDARY Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version |
2.5; 2.4; 0.3; 1.2; 6.0; 6.6 | — |
| SECONDARY Change From Baseline in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics |
91.4; 89.6 | 0.072 |
| SECONDARY Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items) |
0.3; 1.2; 0; 0.3; 15.4; 19.1 | — |
Summary
The main purpose of this study is to determine the efficacy and safety of insulin efsitora alfa (LY3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of T2D according to the World Health Organization criteria.
- Have an HbA1c of 7.0% to 10.0%, inclusive, at screening.
- 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.
- Are insulin naive
Exceptions:
- short-term insulin treatment for a maximum of 14 days, prior to screening, and
- prior insulin treatment for gestational diabetes.
Exclusion Criteria
- Have a diagnosis of type 1 diabetes (T1D), latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes.
- Have a history of >1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.
- Have had severe hypoglycemia episodes within 6 months prior to screening.
- Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
- Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening
- acute myocardial infarction
- cerebrovascular accident (stroke), or
- coronary bypass surgery.
- Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
- Have had significant weight gain or loss within 3 months prior to screening, for example, ≥5%.
Data sourced from ClinicalTrials.gov (NCT05662332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.