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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) | Clinical Trials | Clareo Health

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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)

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

NCT01621178•Eli Lilly and Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+2 more criteria

Locations (89)

Extended Arm Physician, Inc.

Montgomery, Alabama, United States

North American Research Institute

Azusa, California, United States

Renal Consultants Medical Group

Granada Hills, California, United States

Marin Endocrine Associates

Greenbrae, California, United States

Academic Medical Research Institute

Los Angeles, California, United States

Sutter Gould Medical Foundation

Modesto, California, United States

Infosphere

West Hills, California, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

The Center for Diabetes & Endocrine Care

Hollywood, Florida, United States

East Coast Clinical Research

Jacksonville, Florida, United States

Key Dates

Start Date

July 1, 2012

Primary Completion Date

June 1, 2016

Completion Date

December 1, 2016

Last Updated

September 19, 2019

Enrollment

577

ACTUAL participants

Conditions

Type 2 DiabetesChronic Kidney Disease

Interventions

Dulaglutide

DRUG

Insulin glargine

DRUG

Insulin lispro

DRUG

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

NCT07241390

Atherosclerosis Cardiovascular DiseaseChronic Kidney Disease

View study

RECRUITINGNA

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes