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

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: LY2963016; Drug: Lantus®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03338010

I4L-GH-ABET (Other Identifier)

16037

Details and patient eligibility

About

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.

Enrollment: 536 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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536 participants in 2 patient groups

LY2963016

Experimental group

Description:

Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the fasting blood glucose (FBG) ≤100 milligram per deciliter (mg/dL) (5.6 millimoles per litre \[mmol/L\]) while avoiding hypoglycemia. Participants were allowed to continue oral antihyperglycemic medication (OAM).

Treatment:

Drug: LY2963016

Lantus®

Active Comparator group

Description:

Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.

Treatment:

Drug: Lantus®