A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD) (AWARD-7)

Lilly

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease; Type 2 Diabetes

Treatments: Drug: Insulin glargine; Drug: Insulin lispro; Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01621178

13798

2012-000829-44 (EudraCT Number)

H9X-MC-GBDX (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the glycemic efficacy and safety of dulaglutide compared to insulin glargine in the treatment of participants with type 2 diabetes and moderate or severe chronic kidney disease.

Enrollment: 577 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and non-pregnant women aged ≥18 years
• Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5%
• Type 2 diabetes on insulin or insulin + oral antihyperglycemic medication
• Participants with presumed diabetic kidney disease with or without hypertensive nephrosclerosis diagnosed with moderate or severe CKD with estimated glomerular filtration rate (eGFR) of ≥15 to <60 milliliters per minute (mL/min)/1.73 meter squared (m^2)
• Able and willing to perform multiple daily injections
• Body mass index (BMI) between 23 and 45 kilogram/square meter (kg/m^2)

Exclusion criteria

• Stage 5 CKD as defined by eGFR <15 mL/min/1.73 m^2 OR having required dialysis
• Rapidly progressing renal dysfunction likely to require renal replacement
• History of a transplanted organ
• Type 1 diabetes mellitus
• At screening a systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥90 mmHg with or without antihypertensive medication
• An episode of ketoacidosis or hyperosmolar state/coma in the past 6 months or a history of severe hypoglycemia in the past 3 months prior to the Screening Visit
• Cardiovascular conditions within 12 weeks prior to randomization: acute myocardial infarction, New York Heart Association (NYHA) class III or class IV heart failure, or cerebrovascular accident (stroke)
• Acute or chronic hepatitis
• Signs and symptoms of chronic or acute pancreatitis, or were in the past diagnosed with pancreatitis
• Serum calcitonin ≥35 picograms per milliliter (pg/mL) at Screening Visit
• Self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma
• Known history of untreated proliferative retinopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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577 participants in 3 patient groups

Insulin glargine

Active Comparator group

Description:

Insulin glargine was administered subcutaneously (SC) at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.

Treatment:

Drug: Insulin glargine

Drug: Insulin lispro

0.75 mg Dulaglutide

Experimental group

Description:

0.75 milligram (mg) of dulaglutide was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.

Treatment:

Drug: Dulaglutide

Drug: Insulin lispro

1.5 mg Dulaglutide

Experimental group

Description:

1.5 mg of dulaglutide was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.

Treatment:

Drug: Dulaglutide

Drug: Insulin lispro