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Clinical Research of West Florida | Clearwater, FL

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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)

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Lilly

Status and phase

Active, not recruiting
Phase 3

Conditions

Type 2 Diabetes
T2D

Treatments

Drug: Insulin Glargine
Drug: Insulin Efsitora Alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT05662332
I8H-MC-BDCW (Other Identifier)
18261

Details and patient eligibility

About

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.

Enrollment

796 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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%.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

796 participants in 2 patient groups

Insulin Efsitora Alfa
Experimental group
Description:
Participants will receive insulin efsitora alfa subcutaneously (SC) once weekly.
Treatment:
Drug: Insulin Efsitora Alfa
Insulin Glargine
Active Comparator group
Description:
Participants will receive insulin glargine SC once daily.
Treatment:
Drug: Insulin Glargine

Trial contacts and locations

71

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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