Clinical trial NCT01621178: 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)
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Chronic Kidney Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-06-18
Enrollment: 577
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 26 Weeks
Secondary outcomes:
measure: Percentage of Participants Whose HbA1c Was <7.0%
timeFrame: 26 Weeks
measure: Percentage of Participants Whose HbA1c Was <8.0%
timeFrame: 26 Weeks
measure: Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)
timeFrame: Baseline, 26 Weeks
measure: Change From Baseline in Fasting Glucose (FG)
timeFrame: Baseline, 26 Weeks
measure: Change From Baseline in Mean Daily Insulin Lispro Dose
timeFrame: Baseline, 26 Weeks
measure: Percentage of Participants With Estimated Average Glucose <154 mg/dL
timeFrame: 26 Weeks
measure: Change From Baseline in Serum Creatinine (sCr)
timeFrame: Baseline, 26 Weeks
measure: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline, 26 Weeks
measure: Change From Baseline in Estimated Creatinine Clearance (eCrCl)
timeFrame: Baseline, 26 Weeks
measure: Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)
timeFrame: Baseline, 26 Weeks
measure: Change From Baseline in Body Weight
timeFrame: Baseline, 26 Weeks
measure: Percentage of Participants With Self-Reported Hypoglycemic Events (HE)
timeFrame: Baseline through 26 Weeks
measure: Rate of Hypoglycemic Events
timeFrame: Baseline through 26 Weeks
measure: Change From Baseline in HbA1c
timeFrame: Baseline, 52 Weeks
measure: Percentage of Participants Whose HbA1c is <7.0%
timeFrame: 52 Weeks
measure: Percentage of Participants Whose HbA1c is <8.0%
timeFrame: 52 Weeks
measure: Change From Baseline in 8-Point SMPG
timeFrame: Baseline, 52 Weeks
measure: Change From Baseline in FG
timeFrame: Baseline, 52 Weeks
measure: Change in Mean Daily Insulin Lispro Dose
timeFrame: Baseline, 52 Weeks
measure: Percentage of Participants With Estimated Average Glucose <154 mg/dL
timeFrame: 52 Weeks
measure: Change From Baseline in sCr
timeFrame: Baseline, 52 Weeks
measure: Change From Baseline in eGFR
timeFrame: Baseline, 52 Weeks
measure: Change From Baseline in eCrCl
timeFrame: Baseline, 52 Weeks
measure: Change From Baseline in UACR
timeFrame: Baseline, 52 Weeks
measure: Change From Baseline in Body Weight
timeFrame: Baseline, 52 Weeks
measure: Percentage of Participants With Self-Reported Hypoglycemic Events (HE)
timeFrame: Baseline through 52 Weeks
measure: Rate of Hypoglycemic Events (HE)
timeFrame: Baseline through 52 Weeks
measure: Participants With Events of Allergic/Hypersensitivity Reactions
timeFrame: Baseline through 52 Weeks
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Extended Arm Physician, Inc.
state: Alabama
city: Azusa
country: United States
facility: North American Research Institute
state: California
city: Granada Hills
country: United States
facility: Renal Consultants Medical Group
state: California
city: Greenbrae
country: United States
facility: Marin Endocrine Associates
state: California
city: Los Angeles
country: United States
facility: Academic Medical Research Institute
state: California
city: Modesto
country: United States
facility: Sutter Gould Medical Foundation
state: California
city: West Hills
country: United States
facility: Infosphere
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Hollywood
country: United States
facility: The Center for Diabetes & Endocrine Care
state: Florida
city: Jacksonville
country: United States
facility: East Coast Clinical Research
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic
state: Florida
city: Miami
country: United States
facility: Avanced Medical and Pain Mangement Research Clinic (AMPM)
state: Florida
city: Miami
country: United States
facility: Baptist Diabetes Association
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Ocala
country: United States
facility: Discovery Medical Research Group
state: Florida
city: Palm Harbor
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Honolulu
country: United States
facility: University of Hawaii Clinical Research
state: Hawaii
city: Caldwell
country: United States
facility: Boise Kidney & Hypertension Institute
state: Idaho
city: Meridian
country: United States
facility: Pacific Renal Research Institute
state: Idaho
city: Topeka
country: United States
facility: Cotton O'Neil Clinic
state: Kansas
city: Wichita
country: United States
facility: Univ of Kansas Schl of Medicine , Wichita
state: Kansas
city: Rockport
country: United States
facility: Penobscot Bay Medical Center
state: Maine
city: Lincoln
country: United States
facility: Nebraska Nephrology Research Institute, LLC
state: Nebraska
city: Albany
country: United States
facility: Endocrine Group, LLP
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center State University
state: New York
city: Rosedale
country: United States
facility: Institute for clinical studies
state: New York
city: Smithtown
country: United States
facility: Endocrine Associates of Long Island, PC
state: New York
city: Concord
country: United States
facility: Carolina Clinical Trials LLC
state: North Carolina
city: Greenville
country: United States
facility: Physicians East
state: North Carolina
city: Morehead City
country: United States
facility: Diabetes & Endocrinology Consultants PC
state: North Carolina
city: Rocky Mount
country: United States
facility: Boice Willis Clinic, PA
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Partners in Nephrology & Endocrinology
state: Pennsylvania
city: Orangeburg
country: United States
facility: South Carolina Nephrology and Hypertension Center, Inc.
state: South Carolina
city: Sumter
country: United States
facility: Carolina Diabetes & Kidney Ctr. Sumter Medical Specialist
state: South Carolina
city: Chattanooga
country: United States
facility: Southeast Renal Research Institute
state: Tennessee
city: Knoxville
country: United States
facility: Knoxville Kidney Center, PLLC
state: Tennessee
city: Austin
country: United States
facility: Center For Clinical Research
state: Texas
city: Dallas
country: United States
facility: Endocrine Associates of Dallas
state: Texas
city: El Paso
country: United States
facility: Office of Dr. Sergio Rovner
state: Texas
city: Houston
country: United States
facility: Endocrine Associates, LLC
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Houston
country: United States
facility: The Endocrine Center
state: Texas
city: San Antonio
country: United States
facility: San Antonio Kidney Disease Center Physicians Group
state: Texas
city: Spokane
country: United States
facility: Providence Health & Services
state: Washington
city: Belem
country: Brazil
facility: 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: Curitiba
country: Brazil
facility: 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: Juiz De Fora
country: Brazil
facility: 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: Passo Fundo
country: Brazil
facility: 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: Porto Alegre
country: Brazil
facility: 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: Santa Catarina
country: Brazil
facility: 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: São Paulo
country: Brazil
facility: 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: Baja
country: Hungary
facility: 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: Budapest
country: Hungary
facility: 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: Esztergom
country: Hungary
facility: 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: Kaposvar
country: Hungary
facility: 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: Kecskemet
country: Hungary
facility: 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: Pecs
country: Hungary
facility: 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: Satoraljaujhely
country: Hungary
facility: 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: Siofok
country: Hungary
facility: 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: Chihuahua
country: Mexico
facility: 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: Culiacan
country: Mexico
facility: 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: Guadalajara
country: Mexico
facility: 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: Mexico City
country: Mexico
facility: 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: Monterrey
country: Mexico
facility: 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: Gdansk
country: Poland
facility: 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: Lodz
country: Poland
facility: 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: Szczecin
country: Poland
facility: 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: Zgierz
country: Poland
facility: 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: Bacau
country: Romania
facility: 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: Bucharest
country: Romania
facility: 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: Deva
country: Romania
facility: 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: Oradea
country: Romania
facility: 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: Targu Mures
country: Romania
facility: 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: Timisoara
country: Romania
facility: 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: Cape Town
country: South Africa
facility: 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: Durban
country: South Africa
facility: 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: Johannesburg
country: South Africa
facility: 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: Somerset West
country: South Africa
facility: 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: Worcester
country: South Africa
facility: 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: Barcelona
country: Spain
facility: 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: Valencia
country: Spain
facility: 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: Dnipropetrovsk
country: Ukraine
facility: 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: Kyiv
country: Ukraine
facility: 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: Lugansk
country: Ukraine
facility: 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: Poltava
country: Ukraine
facility: 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: Ternopil
country: Ukraine
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
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.