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Recruiting NCT05662332

A Study of LY3209590 Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)

Conditions: Type 2 Diabetes, T2D

Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 670
Sponsor: Eli Lilly and Company

Location: United States

Summary

The main purpose of this study is to determine the efficacy and safety of 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 naiveExceptions:short-term insulin treatment for a maximum of 14 days, prior to screening, andprior 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 screeningacute myocardial infarctioncerebrovascular accident (stroke), orcoronary bypass surgery.Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screeningHave had significant weight gain or loss within 3 months prior to screening, for example, ≥5%.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05662332). StuddyBuddy aggregates publicly available trial information.