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)

• Status: Not yet recruiting
• Trial end date: 2024-07-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin Glargine

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%.