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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) (AWARD-7)

Primary Purpose

Type 2 Diabetes, Chronic Kidney Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dulaglutide

Insulin glargine

Insulin lispro

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Extended Arm Physician, Inc.
North American Research Institute
Renal Consultants Medical Group
Marin Endocrine Associates
Academic Medical Research Institute
Sutter Gould Medical Foundation
Infosphere
Chase Medical Research, LLC
The Center for Diabetes & Endocrine Care
East Coast Clinical Research
Ocean Blue Medical Research Center, Inc.
San Marcus Research Clinic, Inc.
Pharmax Research Clinic
Avanced Medical and Pain Mangement Research Clinic (AMPM)
Baptist Diabetes Association
Suncoast Clinical Research
Discovery Medical Research Group
Suncoast Clinical Research
University of Hawaii Clinical Research
Boise Kidney & Hypertension Institute
Pacific Renal Research Institute
Cotton O'Neil Clinic
Univ of Kansas Schl of Medicine , Wichita
Penobscot Bay Medical Center
Nebraska Nephrology Research Institute, LLC
Endocrine Group, LLP
Erie County Medical Center State University
Institute for clinical studies
Endocrine Associates of Long Island, PC
Carolina Clinical Trials LLC
Physicians East
Diabetes & Endocrinology Consultants PC
Boice Willis Clinic, PA
Thomas Jefferson University
Partners in Nephrology & Endocrinology
South Carolina Nephrology and Hypertension Center, Inc.
Carolina Diabetes & Kidney Ctr. Sumter Medical Specialist
Southeast Renal Research Institute
Knoxville Kidney Center, PLLC
Center For Clinical Research
Endocrine Associates of Dallas
Office of Dr. Sergio Rovner
Endocrine Associates, LLC
Juno Research
The Endocrine Center
San Antonio Kidney Disease Center Physicians Group
Providence Health & Services
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Insulin glargine

0.75 mg Dulaglutide

1.5 mg Dulaglutide

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin A1c (HbA1c)

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means in HbA1c were calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, macroalbuminuria (MA) region, Baseline CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.

Secondary Outcome Measures

Percentage of Participants Whose HbA1c Was <7.0%

Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF).

Percentage of Participants Whose HbA1c Was <8.0%

Percentage of Participants whose HbA1c was <8.0% based on last observation carried forward (LOCF).

Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)

The daily mean of 8-point SMPG profile at Week 26 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x [morning, midday, and evening meals in one day] + bedtime + 5 hours after bedtime).

Change From Baseline in Fasting Glucose (FG)

LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured

Change From Baseline in Mean Daily Insulin Lispro Dose

The mean daily insulin was based on a 4-week interval prior to week 26 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.

Percentage of Participants With Estimated Average Glucose <154 mg/dL

Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).

Change From Baseline in Serum Creatinine (sCr)

Change from baseline in serum creatinine (sCr) levels after treatment.

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

The change in estimated glomerular filtration rate (eGFR) by using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.

Change From Baseline in Estimated Creatinine Clearance (eCrCl)

Estimated creatinine clearance (eCrCl) was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight.

Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)

The change from baseline in Urinary Albumin to Creatinine Ratio (UACR).

Change From Baseline in Body Weight

LS means were calculated from a REML based MMRM model: Change from Baseline = treatment, week, treatment*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured. •

Percentage of Participants With Self-Reported Hypoglycemic Events (HE)

Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.

Rate of Hypoglycemic Events

Hypoglycemic events (HE) were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.

Change From Baseline in HbA1c

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means in HbA1c were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, MA region, Baseline CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.

Percentage of Participants Whose HbA1c is <7.0%

Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF).

Percentage of Participants Whose HbA1c is <8.0%

Percentage of participants whose HbA1c was <8.0% based on last observation carried forward (LOCF).

Change From Baseline in 8-Point SMPG

The daily mean of 8-point SMPG profile at Week 52 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x [morning, midday, and evening meals in one day] + bedtime + 5 hours after bedtime).

Change From Baseline in FG

Change in Mean Daily Insulin Lispro Dose

The mean daily insulin was based on a 4-week interval prior to week 52 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.

Percentage of Participants With Estimated Average Glucose <154 mg/dL

Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).

Change From Baseline in sCr

Change from baseline in sCr levels after treatment.

Change From Baseline in eGFR

The change in eGFR by using CKD-EPI equation.

Change From Baseline in eCrCl

eCrCl was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight.

Change From Baseline in UACR

The change from baseline in UACR

Change From Baseline in Body Weight

LS means were calculated from a REML based MMRM model: Change from Baseline = treatment , week, treatment*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured.

Percentage of Participants With Self-Reported Hypoglycemic Events (HE)

Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.

Rate of Hypoglycemic Events (HE)

HE were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.

Participants With Events of Allergic/Hypersensitivity Reactions

Participants with Events of Allergic/Hypersensitivity Reactions: Angioedema Standardized MedDRA Query (SMQ), Anaphylactic Reaction SMQ, or Severe Cutaneous Adverse Reactions SMQ

Full Information

NCT ID

NCT01621178

First Posted

June 14, 2012

Last Updated

September 6, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01621178

Brief Title

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)

Acronym

AWARD-7

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Chronic Kidney Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

Dulaglutide dose was blinded to participant, care provider, investigator and outcomes assessor.

Allocation

Randomized

Enrollment

577 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin glargine

Arm Type

Active Comparator

Arm Description

Arm Title

0.75 mg Dulaglutide

Arm Type

Experimental

Arm Description

Arm Title

1.5 mg Dulaglutide

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dulaglutide

Other Intervention Name(s)

LY2189265

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Insulin glargine

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Insulin lispro

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

Change From Baseline in Hemoglobin A1c (HbA1c)

Description

Time Frame

Baseline, 26 Weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants Whose HbA1c Was <7.0%

Description

Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF).

Time Frame

26 Weeks

Title

Percentage of Participants Whose HbA1c Was <8.0%

Description

Percentage of Participants whose HbA1c was <8.0% based on last observation carried forward (LOCF).

Time Frame

26 Weeks

Title

Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)

Description

Time Frame

Baseline, 26 Weeks

Title

Change From Baseline in Fasting Glucose (FG)

Description

Time Frame

Baseline, 26 Weeks

Title

Change From Baseline in Mean Daily Insulin Lispro Dose

Description

Time Frame

Baseline, 26 Weeks

Title

Percentage of Participants With Estimated Average Glucose <154 mg/dL

Description

Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).

Time Frame

26 Weeks

Title

Change From Baseline in Serum Creatinine (sCr)

Description

Change from baseline in serum creatinine (sCr) levels after treatment.

Time Frame

Baseline, 26 Weeks

Title

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

Description

The change in estimated glomerular filtration rate (eGFR) by using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.

Time Frame

Baseline, 26 Weeks

Title

Change From Baseline in Estimated Creatinine Clearance (eCrCl)

Description

Estimated creatinine clearance (eCrCl) was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight.

Time Frame

Baseline, 26 Weeks

Title

Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)

Description

The change from baseline in Urinary Albumin to Creatinine Ratio (UACR).

Time Frame

Baseline, 26 Weeks

Title

Change From Baseline in Body Weight

Description

Time Frame

Baseline, 26 Weeks

Title

Percentage of Participants With Self-Reported Hypoglycemic Events (HE)

Description

Time Frame

Baseline through 26 Weeks

Title

Rate of Hypoglycemic Events

Description

Time Frame

Baseline through 26 Weeks

Title

Change From Baseline in HbA1c

Description

Time Frame

Baseline, 52 Weeks

Title

Percentage of Participants Whose HbA1c is <7.0%

Description

Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF).

Time Frame

52 Weeks

Title

Percentage of Participants Whose HbA1c is <8.0%

Description

Percentage of participants whose HbA1c was <8.0% based on last observation carried forward (LOCF).

Time Frame

52 Weeks

Title

Change From Baseline in 8-Point SMPG

Description

Time Frame

Baseline, 52 Weeks

Title

Change From Baseline in FG

Description

Time Frame

Baseline, 52 Weeks

Title

Change in Mean Daily Insulin Lispro Dose

Description

Time Frame

Baseline, 52 Weeks

Title

Percentage of Participants With Estimated Average Glucose <154 mg/dL

Description

Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).

Time Frame

52 Weeks

Title

Change From Baseline in sCr

Description

Change from baseline in sCr levels after treatment.

Time Frame

Baseline, 52 Weeks

Title

Change From Baseline in eGFR

Description

The change in eGFR by using CKD-EPI equation.

Time Frame

Baseline, 52 Weeks

Title

Change From Baseline in eCrCl

Description

eCrCl was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight.

Time Frame

Baseline, 52 Weeks

Title

Change From Baseline in UACR

Description

The change from baseline in UACR

Time Frame

Baseline, 52 Weeks

Title

Change From Baseline in Body Weight

Description

LS means were calculated from a REML based MMRM model: Change from Baseline = treatment , week, treatment*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured.

Time Frame

Baseline, 52 Weeks

Title

Percentage of Participants With Self-Reported Hypoglycemic Events (HE)

Description

Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.

Time Frame

Baseline through 52 Weeks

Title

Rate of Hypoglycemic Events (HE)

Description

Time Frame

Baseline through 52 Weeks

Title

Participants With Events of Allergic/Hypersensitivity Reactions

Description

Participants with Events of Allergic/Hypersensitivity Reactions: Angioedema Standardized MedDRA Query (SMQ), Anaphylactic Reaction SMQ, or Severe Cutaneous Adverse Reactions SMQ

Time Frame

Baseline through 52 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Extended Arm Physician, Inc.

City

Montgomery

State/Province

Alabama

ZIP/Postal Code

36106

Country

United States

Facility Name

North American Research Institute

City

Azusa

State/Province

California

ZIP/Postal Code

91702

Country

United States

Facility Name

Renal Consultants Medical Group

City

Granada Hills

State/Province

California

ZIP/Postal Code

91344

Country

United States

Facility Name

Marin Endocrine Associates

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

Facility Name

Academic Medical Research Institute

City

Los Angeles

State/Province

California

ZIP/Postal Code

90022

Country

United States

Facility Name

Sutter Gould Medical Foundation

City

Modesto

State/Province

California

ZIP/Postal Code

95355

Country

United States

Facility Name

Infosphere

City

West Hills

State/Province

California

ZIP/Postal Code

91307

Country

United States

Facility Name

Chase Medical Research, LLC

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

The Center for Diabetes & Endocrine Care

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33312

Country

United States

Facility Name

East Coast Clinical Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

Ocean Blue Medical Research Center, Inc.

City

Miami Springs

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

San Marcus Research Clinic, Inc.

City

Miami

State/Province

Florida

ZIP/Postal Code

33015

Country

United States

Facility Name

Pharmax Research Clinic

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Avanced Medical and Pain Mangement Research Clinic (AMPM)

City

Miami

State/Province

Florida

ZIP/Postal Code

33145

Country

United States

Facility Name

Baptist Diabetes Association

City

Miami

State/Province

Florida

ZIP/Postal Code

33156

Country

United States

Facility Name

Suncoast Clinical Research

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Discovery Medical Research Group

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Suncoast Clinical Research

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

University of Hawaii Clinical Research

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

Facility Name

Boise Kidney & Hypertension Institute

City

Caldwell

State/Province

Idaho

ZIP/Postal Code

83605

Country

United States

Facility Name

Pacific Renal Research Institute

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Cotton O'Neil Clinic

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Univ of Kansas Schl of Medicine , Wichita

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Penobscot Bay Medical Center

City

Rockport

State/Province

Maine

ZIP/Postal Code

04854

Country

United States

Facility Name

Nebraska Nephrology Research Institute, LLC

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

Country

United States

Facility Name

Endocrine Group, LLP

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

Erie County Medical Center State University

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

Institute for clinical studies

City

Rosedale

State/Province

New York

ZIP/Postal Code

11422

Country

United States

Facility Name

Endocrine Associates of Long Island, PC

City

Smithtown

State/Province

New York

ZIP/Postal Code

11787

Country

United States

Facility Name

Carolina Clinical Trials LLC

City

Concord

State/Province

North Carolina

ZIP/Postal Code

28025

Country

United States

Facility Name

Physicians East

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Diabetes & Endocrinology Consultants PC

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557

Country

United States

Facility Name

Boice Willis Clinic, PA

City

Rocky Mount

State/Province

North Carolina

ZIP/Postal Code

27804

Country

United States

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Partners in Nephrology & Endocrinology

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

South Carolina Nephrology and Hypertension Center, Inc.

City

Orangeburg

State/Province

South Carolina

ZIP/Postal Code

29118

Country

United States

Facility Name

Carolina Diabetes & Kidney Ctr. Sumter Medical Specialist

City

Sumter

State/Province

South Carolina

ZIP/Postal Code

29150

Country

United States

Facility Name

Southeast Renal Research Institute

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37408

Country

United States

Facility Name

Knoxville Kidney Center, PLLC

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37923

Country

United States

Facility Name

Center For Clinical Research

City

Austin

State/Province

Texas

ZIP/Postal Code

78758

Country

United States

Facility Name

Endocrine Associates of Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Office of Dr. Sergio Rovner

City

El Paso

State/Province

Texas

ZIP/Postal Code

79925

Country

United States

Facility Name

Endocrine Associates, LLC

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Juno Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77036

Country

United States

Facility Name

The Endocrine Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77079

Country

United States

Facility Name

San Antonio Kidney Disease Center Physicians Group

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Providence Health & Services

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Belem

ZIP/Postal Code

66073-000

Country

Brazil

Facility Name

City

Curitiba

ZIP/Postal Code

80240-000

Country

Brazil

Facility Name

City

Juiz De Fora

ZIP/Postal Code

36036-330

Country

Brazil

Facility Name

City

Passo Fundo

ZIP/Postal Code

99010-080

Country

Brazil

Facility Name

City

Porto Alegre

ZIP/Postal Code

90610000

Country

Brazil

Facility Name

City

Santa Catarina

ZIP/Postal Code

89227680

Country

Brazil

Facility Name

City

São Paulo

ZIP/Postal Code

04025-011

Country

Brazil

Facility Name

City

Baja

ZIP/Postal Code

6500

Country

Hungary

Facility Name

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

City

Esztergom

ZIP/Postal Code

2500

Country

Hungary

Facility Name

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

City

Pecs

ZIP/Postal Code

7623

Country

Hungary

Facility Name

City

Satoraljaujhely

ZIP/Postal Code

H-3980

Country

Hungary

Facility Name

City

Siofok

ZIP/Postal Code

8600

Country

Hungary

Facility Name

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

City

Culiacan

ZIP/Postal Code

80030

Country

Mexico

Facility Name

City

Guadalajara

ZIP/Postal Code

44650

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

11850

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64000

Country

Mexico

Facility Name

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

City

Lodz

ZIP/Postal Code

90302

Country

Poland

Facility Name

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

City

Zgierz

ZIP/Postal Code

95-100

Country

Poland

Facility Name

City

Bacau

ZIP/Postal Code

600114

Country

Romania

Facility Name

City

Bucharest

ZIP/Postal Code

020045

Country

Romania

Facility Name

City

Deva

ZIP/Postal Code

330084

Country

Romania

Facility Name

City

Oradea

ZIP/Postal Code

410167

Country

Romania

Facility Name

City

Targu Mures

ZIP/Postal Code

540142

Country

Romania

Facility Name

City

Timisoara

ZIP/Postal Code

300125

Country

Romania

Facility Name

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

City

Durban

ZIP/Postal Code

4091

Country

South Africa

Facility Name

City

Johannesburg

ZIP/Postal Code

2198

Country

South Africa

Facility Name

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

Facility Name

City

Worcester

ZIP/Postal Code

6850

Country

South Africa

Facility Name

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

City

Dnipropetrovsk

ZIP/Postal Code

49005

Country

Ukraine

Facility Name

City

Kyiv

ZIP/Postal Code

2091

Country

Ukraine

Facility Name

City

Lugansk

ZIP/Postal Code

91045

Country

Ukraine

Facility Name

City

Poltava

ZIP/Postal Code

36011

Country

Ukraine

Facility Name

City

Ternopil

ZIP/Postal Code

46002

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

29910024

Citation

Tuttle KR, Lakshmanan MC, Rayner B, Busch RS, Zimmermann AG, Woodward DB, Botros FT. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018 Aug;6(8):605-617. doi: 10.1016/S2213-8587(18)30104-9. Epub 2018 Jun 14.

Results Reference

derived

Learn more about this trial

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)

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