A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2020-03-18
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in insulin naïve adult Chinese participants with Type 2 Diabetes Mellitus (T2DM) on 2 or more oral antihyperglycemic medications (OAMs). Participants will continue their OAMs throughout the study.

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

Details

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

Criteria

Inclusion Criteria:

• Have T2DM based on the disease diagnostic criteria World Health Organization (WHO) classification.

• Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to screening.

• Have a HbA1c ≥7.0% and ≤11.0%.

• Body mass index (BMI) ≤35 kilograms per meter squared.

Exclusion Criteria:

• Have used insulin therapy (outside of pregnancy) anytime in the past 1 year, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks.

• Have used any glucagon like peptide (GLP-1) receptor agonists within the previous 90 days.

• Are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening.

• Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.

• Have had ≥2 emergency room visits or hospitalizations due to poor glucose control.

• Have known hypersensitivity or allergy to Lantus® or its excipients.

• Are receiving chronic systemic glucocorticoid therapy at pharmacological doses or have received such therapy within 4 weeks immediately preceding screening.

• Have obvious signs or symptoms, or laboratory evidence, of liver disease.

• Have one of the following concomitant diseases: significant cardiac or gastrointestinal disease.

• Have a history of renal transplantation, are currently receiving renal dialysis or have a serum creatinine greater than 2.0 milligrams per deciliter.

• Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.

• Participants with active cancer or personal history of cancer within the previous 5 years.

• Are pregnant or intend to become pregnant during the course of the study.

• Are women who are breastfeeding.