A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: LY2189265; Drug: Insulin Glargine; Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT01191268

11376

H9X-MC-GBDD (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.

Full description

The term rescue therapy in this trial was defined as therapy for participants who met criteria for persistent severe hyperglycemia and therapy for participants who required new intervention for any other reason. The latter included participants who discontinued study drug due to adverse events, participant decision, or any other reason. For efficacy analyses, participants who received rescue medication were included in the analysis population, but only measurements obtained prior to taking rescue therapy were included in the efficacy analysis. For safety analyses, with the exception of hypoglycemia, all measurements including those obtained after taking rescue therapy were included in the analysis.

Enrollment: 884 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications
• Glycosylated hemoglobin (HbA1c) greater than or equal to 7% and less than or equal to 11%
• Willing to inject subcutaneous medication
• Willing to monitor blood glucose levels and adjust insulin dose
• Willing to maintain a study diary
• Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)
• Stable weight for 3 months prior to screening
• Females of child bearing potential must test negative for pregnancy at screening and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug

Exclusion criteria

• Type 1 Diabetes
• Previous therapy with glucagon-like peptide 1 (GLP-1) agonists within 3 months prior to screening
• 1 or more episodes of ketoacidosis within 6 months prior to screening
• Have been treated with prescription or over the counter medication to promote weight loss within 3 months prior to screening
• Estimated glomerular filtration rate (eGFR) less than or equal to 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) at screening
• Taking steroids for greater than 14 days except for topical, eye, nasal, or inhaled
• History of heart failure, New York Heart Classification III or IV within 2 months prior to screening
• Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking medications that directly affect GI motility
• Acute or chronic hepatitis or pancreatitis
• Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary C-Cell hyperplasia
• Serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/mL) at screening
• Organ transplant except cornea
• Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
• History of or active malignancy except skin or in situ cervical or prostate cancer within the last 5 years
• Known drug or alcohol abuse
• Have enrolled in another clinical trial within the last 30 days
• Have previously signed an informed consent or participated in a LY2189265 study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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884 participants in 3 patient groups

1.5 mg LY2189265

Experimental group

Description:

LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

Treatment:

Drug: LY2189265

Drug: Insulin Lispro

0.75 mg LY2189265

Experimental group

Description:

LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

Treatment:

Drug: LY2189265

Drug: Insulin Lispro

Insulin Glargine

Active Comparator group

Description:

Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

Treatment:

Drug: Insulin Glargine

Drug: Insulin Lispro