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) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Chronic Kidney Disease	Drug: Dulaglutide Drug: Insulin glargine Drug: Insulin lispro	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin human Insulin lispro Insulin glargine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from Baseline in HbA1c at 52 Weeks [ Time Frame: Baseline, 52 Weeks ] [ Designated as safety issue: No ]
Percentage of Participants whose HbA1c is <7.0% at 26 Weeks and 52 Weeks [ Time Frame: 26 Weeks and 52 Weeks ] [ Designated as safety issue: No ]
Percentage of Participants whose HbA1c is <8.0% at 26 Weeks and 52 Weeks [ Time Frame: 26 Weeks and 52 Weeks ] [ Designated as safety issue: No ]
Change from Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
Change from Baseline in Fasting Glucose at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
Mean Daily Insulin Lispro Use at 26 Weeks and 52 Weeks [ Time Frame: 26 Weeks and 52 Weeks ] [ Designated as safety issue: No ]
Percentage of Participants with estimated average glucose <154 mg/dL at 26 Weeks and 52 Weeks [ Time Frame: 26 Weeks and 52 Weeks ] [ Designated as safety issue: No ]
Change from Baseline in Serum Creatinine (SCr) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
Change from Baseline in estimated Glomerular Filtration Rate (eGFR) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
Change from Baseline in estimated Creatinine Clearance (eCrCl) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
Change from Baseline in Urinary Albumin to Creatinine Ratio (UACR) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
Change from Baseline in Body Weight at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
Percentage of Participants with Hypoglycemic Episodes [ Time Frame: Baseline through 26 Weeks and Baseline through 52 Weeks ] [ Designated as safety issue: No ]
Hypoglycemic Episode Rate [ Time Frame: Baseline through 26 Weeks and Baseline through 52 Weeks ] [ Designated as safety issue: No ]
Percentage of Participants with Allergic/Hypersensitivity Reactions [ Time Frame: Baseline through 52 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	564
Study Start Date:	July 2012
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dulaglutide 0.75 mg 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.	Drug: Dulaglutide Administered SQ Other Name: LY2189265 Drug: Insulin lispro Administered SQ
Experimental: Dulaglutide 1.5 mg 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.	Drug: Dulaglutide Administered SQ Other Name: LY2189265 Drug: Insulin lispro Administered SQ
Active Comparator: Insulin glargine 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.	Drug: Insulin glargine Administered SQ Drug: Insulin lispro Administered SQ

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621178

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Show 87 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01621178 History of Changes
Other Study ID Numbers:	13798, H9X-MC-GBDX, 2012-000829-44
Study First Received:	June 14, 2012
Last Updated:	June 14, 2013
Health Authority:	United States: Food and Drug Administration Mexico: Federal Commission for Sanitary Risks Protection Mexico: Ministry of Health Brazil: National Health Surveillance Agency Spain: Spanish Agency of Medicines South Africa: Medicines Control Council Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Ukraine: Ethics Committee Ukraine: Ministry of Health Romania: National Agency for Medicines and Medical Devices India: Drugs Controller General of India

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases

Renal Insufficiency
Insulin LISPRO
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013

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)