A Study in Adults With Type 2 Diabetes (ELEMENT 2)

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Lantus; Drug: OAMs; Drug: LY2963016

Study type: Interventional

Funder types: Industry

Identifiers

NCT01421459

I4L-MC-ABEC (Other Identifier)

13713

2011-000828-15 (EudraCT Number)

Details and patient eligibility

About

The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.

Enrollment: 759 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have Type 2 Diabetes Mellitus based on the disease diagnostic criteria World Health Organization (WHO) classification
• Have been taking at least 2 types of oral diabetes medications for at least 12 weeks prior to entering the study
• Have a Hemoglobin A1c value greater than or equal to 7.0 percent and less than or equal to 11.0 percent if insulin naive If previously on Lantus, then Hemoglobin A1c must be less than or equal to 11.0 percent
• Have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m^2)

Exclusion criteria

• Have significant liver, cardiac or gastrointestinal disease
• Have active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
• Have an excessive resistance to insulin or hypersensitivity to Lantus
• Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
• Have taken any other insulin other than Lantus within the past 30 days
• Taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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759 participants in 2 patient groups

LY2963016 + OAMs

Experimental group

Description:

LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) \[alpha glucosidase inhibitors (AGI), dipeptidyl peptidases intravenous (DPP-IV), meglitinide (MEG), metformin (MET), sulfonylurea (SU), and thiazolidinedione (TZD)\] administered per standard of care for 24 weeks

Treatment:

Drug: LY2963016

Drug: OAMs

Lantus + OAMs

Active Comparator group

Description:

Lantus titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 OAMs (AGI, DPP-IV, MEG, MET, SU, and TZD) administered per standard of care for 24 weeks

Treatment:

Drug: Lantus

Drug: OAMs