A Study of LY3209590 Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time

JRCT ID: jRCT2031220290

Registered date:26/08/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Diabetes,Type 2 Diabetes
• Date of first enrollment: 09/07/2022
• Target sample size: 912
• Countries of recruitment: Brazil,Japan,Canada,Japan,China,Japan,Czechia,Japan,Germany,Japan,Greece,Japan,Korea, Republic of,Japan,Mexico,Japan,Puerto Rico,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

-Drug: LY3209590
Administered SC
-Drug: Insulin Degludec
Administered SC

Study Arms
-Experimental: LY3209590
Participants will receive LY3209590 subcutaneously (SC) once weekly.
Intervention: Drug: LY3209590
-Active Comparator: Insulin Degludec
Participants will receive insulin degludec SC once daily
Intervention: Drug: Insulin Degludec

Outcome(s)

Primary Outcome

Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 52 ]
Change from Baseline in HbA1c of LY3209590 compared to insulin degludec for the treatment of type 2 diabetes (T2D) in adults.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Have diagnosis of T2D according to the World Health Organization Criteria
-Have an HbA1c of 7.0% - 10% 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

Exclude criteria

-Have a diagnosis of 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%.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05362058