Overview

This trial is active, not recruiting.

Conditions type 2 diabetes, chronic kidney disease
Treatments dulaglutide, insulin glargine, insulin lispro
Phase phase 3
Sponsor Eli Lilly and Company
Start date July 2012
End date December 2016
Trial size 576 participants
Trial identifier NCT01621178, 13798, 2012-000829-44, H9X-MC-GBDX

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Dulaglutide 0.75 milligram (mg) administered once weekly as a subcutaneous (SQ) injection. Participants will be instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
dulaglutide LY2189265
Administered SQ
insulin lispro
Administered SQ
(Experimental)
Dulaglutide 1.5 mg administered once weekly as a SQ injection. Participants will be instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
dulaglutide LY2189265
Administered SQ
insulin lispro
Administered SQ
(Active Comparator)
Insulin glargine administered SQ to be given at bedtime per sliding scale. Participants will be instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
insulin glargine
Administered SQ
insulin lispro
Administered SQ

Primary Outcomes

Measure
Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks
time frame: Baseline, 26 Weeks

Secondary Outcomes

Measure
Change from Baseline in HbA1c at 52 Weeks
time frame: Baseline, 52 Weeks
Percentage of Participants whose HbA1c is <7.0% at 26 Weeks and 52 Weeks
time frame: 26 Weeks and 52 Weeks
Percentage of Participants whose HbA1c is <8.0% at 26 Weeks and 52 Weeks
time frame: 26 Weeks and 52 Weeks
Change from Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG) at 26 Weeks and 52 Weeks
time frame: Baseline, 26 Weeks, 52 Weeks
Change from Baseline in Fasting Glucose at 26 Weeks and 52 Weeks
time frame: Baseline, 26 Weeks, 52 Weeks
Mean Daily Insulin Lispro Use at 26 Weeks and 52 Weeks
time frame: 26 Weeks and 52 Weeks
Percentage of Participants with estimated average glucose <154 mg/dL at 26 Weeks and 52 Weeks
time frame: 26 Weeks and 52 Weeks
Change from Baseline in Serum Creatinine (SCr) at 26 Weeks and 52 Weeks
time frame: Baseline, 26 Weeks, 52 Weeks
Change from Baseline in estimated Glomerular Filtration Rate (eGFR) at 26 Weeks and 52 Weeks
time frame: Baseline, 26 Weeks, 52 Weeks
Change from Baseline in estimated Creatinine Clearance (eCrCl) at 26 Weeks and 52 Weeks
time frame: Baseline, 26 Weeks, 52 Weeks
Change from Baseline in Urinary Albumin to Creatinine Ratio (UACR) at 26 Weeks and 52 Weeks
time frame: Baseline, 26 Weeks, 52 Weeks
Change from Baseline in Body Weight at 26 Weeks and 52 Weeks
time frame: Baseline, 26 Weeks, 52 Weeks
Percentage of Participants with Hypoglycemic Episodes
time frame: Baseline through 26 Weeks and Baseline through 52 Weeks
Hypoglycemic Episode Rate
time frame: Baseline through 26 Weeks and Baseline through 52 Weeks
Percentage of Participants with Allergic/Hypersensitivity Reactions
time frame: Baseline through 52 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-weekly Dulaglutide With Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes and Moderate or Severe Chronic Kidney Disease
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.