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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01621178
First Posted: June 18, 2012
Last Update Posted: July 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
June 14, 2012
June 18, 2012
June 21, 2017
July 24, 2017
July 24, 2017
July 2012
June 2016   (Final data collection date for primary outcome measure)
Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 26 Weeks ]
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.
Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ]
Complete list of historical versions of study NCT01621178 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Whose HbA1c Was <7.0% [ Time Frame: 26 Weeks ]
    Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF).
  • Percentage of Participants Whose HbA1c Was <8.0% [ Time Frame: 26 Weeks ]
    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) [ Time Frame: Baseline, 26 Weeks ]
    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) [ Time Frame: Baseline, 26 Weeks ]
    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 [ Time Frame: 26 Weeks ]
    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 HbA1c as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, 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 With Estimated Average Glucose <154 mg/dL [ Time Frame: 26 Weeks ]
    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) [ Time Frame: Baseline, 26 Weeks ]
    Change from baseline in serum creatinine (sCr) levels after treatment.
  • Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Baseline, 26 Weeks ]
    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) [ Time Frame: Baseline, 26 Weeks ]
    eEstimated 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) [ Time Frame: Baseline, 26 Weeks ]
    The change from baseline in Urinary Albumin to Creatinine Ratio (UACR).
  • Change From Baseline in Body Weight [ Time Frame: Baseline, 26 Weeks ]
    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) [ Time Frame: Baseline through 26 Weeks ]
    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 [ Time Frame: Baseline through 26 Weeks ]
    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 [ Time Frame: Baseline, 52 Weeks ]
  • Percentage of Participants Whose HbA1c is <7.0% [ Time Frame: 52 Weeks ]
  • Percentage of Participants Whose HbA1c is <8.0% [ Time Frame: Baseline, 52 Weeks ]
  • Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG) [ Time Frame: Baseline, 52 Weeks ]
  • Change From Baseline in Fasting Glucose [ Time Frame: Baseline, 52 Weeks ]
  • Change in Mean Daily Insulin Lispro Dose [ Time Frame: Baseline, 52 Weeks ]
  • Percentage of Participants With Estimated Average Glucose <154 mg/dL [ Time Frame: Baseline, 52 Weeks ]
  • Change From Baseline in Serum Creatinine (sCr) [ Time Frame: Baseline, 52 Weeks ]
  • Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Baseline, 52 Weeks ]
  • Change From Baseline in Estimated Creatinine Clearance (eCrCl) [ Time Frame: Baseline, 52 Weeks ]
  • Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) [ Time Frame: Baseline, 52 Weeks ]
  • Change From Baseline in Body Weight [ Time Frame: Baseline, 52 Weeks ]
  • Percentage of Participants With Self-Reported HE [ Time Frame: Baseline, 52 Weeks ]
  • Rate of HE [ Time Frame: Baseline, 52 Weeks ]
  • Percentage of Participants With Allergic/Hypersensitivity Reactions [ Time Frame: Baseline through 52 Weeks ]
  • 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 ]
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Dulaglutide dose was blinded to participant, care provider, investigator and outcomes assessor.
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Chronic Kidney Disease
  • Drug: Dulaglutide
    Administered SQ
    Other Name: LY2189265
  • Drug: Insulin glargine
    Administered SQ
  • Drug: Insulin lispro
    Administered SQ
  • Active Comparator: Insulin glargine
    Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
    Interventions:
    • Drug: Insulin glargine
    • Drug: Insulin lispro
  • Experimental: 0.75 mg Dulaglutide
    0.75 milligram (mg) of dulaglutide was administered once weekly as a subcutaneous (SQ) injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
    Interventions:
    • Drug: Dulaglutide
    • Drug: Insulin lispro
  • Experimental: 1.5 mg Dulaglutide
    1.5 mg of dulaglutide was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
    Interventions:
    • Drug: Dulaglutide
    • Drug: Insulin lispro
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
577
December 2016
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Hungary,   Mexico,   Poland,   Romania,   South Africa,   Spain,   Ukraine,   United States
India
 
NCT01621178
13798
H9X-MC-GBDX ( Other Identifier: Eli Lilly and Company )
2012-000829-44 ( EudraCT Number )
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual participant data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP