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 is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01621178
First received: June 14, 2012
Last updated: September 2, 2014
Last verified: September 2014
  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:


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: October 2016
Estimated Primary Completion Date: October 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Extended Arm Physician, Inc. Recruiting
Montgomery, Alabama, United States, 36106
Contact    334-265-1911      
Principal Investigator: Leon Davis         
United States, California
North American Research Institute Recruiting
Azusa, California, United States, 91702
Contact    800-797-1695      
Principal Investigator: Aamir Jamal         
Marin Endocrine Associates Recruiting
Greenbrae, California, United States, 94904
Contact    415-461-9113      
Principal Investigator: Linda Gaudiani         
Academic Medical Research Institute Recruiting
Los Angeles, California, United States, 90022
Contact    323-725-7149      
Principal Investigator: Mohamed El-Shahawy         
Sutter Gould Medical Foundation Recruiting
Modesto, California, United States, 95355
Contact    209-524-1211      
Principal Investigator: Celina Hetnal         
Infosphere Recruiting
West Hills, California, United States, 91307
Contact    818-222-6868      
Principal Investigator: Dan Streja         
United States, Connecticut
Chase Medical Research, LLC Recruiting
Waterbury, Connecticut, United States, 06708
Contact    203-419-4420      
Principal Investigator: Joseph Soufer         
United States, District of Columbia
George Washington University Medical Center Recruiting
Washington, District of Columbia, United States, 20037
Contact    202-741-2283      
Principal Investigator: Dominic Raj         
United States, Florida
The Ctr. For Diabetes & Endocrine Care Recruiting
Hollywood, Florida, United States, 33021
Contact    954-963-7100      
Principal Investigator: Sam Lerman         
East Coast Clinical Research Recruiting
Jacksonville, Florida, United States, 32204
Contact    904-384-2240      
Principal Investigator: David Sutton         
Baptist Diabetes Association Recruiting
Miami, Florida, United States, 33156
Contact    305-595-8252      
Principal Investigator: Peter Weissman         
Avanced Medical and Pain Mangement Research Clinic (AMPM) Recruiting
Miami, Florida, United States, 33145
Contact    305-646-6955      
Principal Investigator: Abel Murillo         
Pharmax Research Clinic Recruiting
Miami, Florida, United States, 33216
Contact    305-262-4231      
Principal Investigator: Jorge Venereo         
San Marcus Research Clinic, Inc. Recruiting
Miami, Florida, United States, 33015
Contact    305-424-7420      
Principal Investigator: Julio Fernandez-Bombino         
Ocean Blue Medical Research Center, Inc. Recruiting
Miami Springs, Florida, United States, 33166
Contact    305-885-8983      
Principal Investigator: Antonio Terrelonge         
Suncoast Clinical Research Recruiting
New Port Richey, Florida, United States, 34652
Contact    727-849-4131      
Principal Investigator: Visal Numrungroad         
Discovery Medical Research Group Recruiting
Ocala, Florida, United States, 34471
Contact    352-622-0530      
Principal Investigator: Melvin Seek         
Suncoast Clinical Research Recruiting
Palm Harbor, Florida, United States, 34684
Contact    727-849-4131      
Principal Investigator: Sanford Plevin         
United States, Hawaii
University of Hawaii Clinical Research Recruiting
Honolulu, Hawaii, United States, 96813
Contact    808-587-8622      
Principal Investigator: Richard Arakaki         
United States, Idaho
Pacific Renal Research Institute Recruiting
Meridian, Idaho, United States, 83642
Contact    208-846-8335      
Principal Investigator: Arnold Silva         
United States, Kansas
Cotton O'Neil Clinic Recruiting
Topeka, Kansas, United States, 66606
Contact    785-368-0482      
Principal Investigator: Alan Wynne         
Univ of Kansas Schl of Medicine , Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact    316-263-7285      
Principal Investigator: Dennis Ross         
United States, Maine
Penobscot Bay Medical Center Recruiting
Rockport, Maine, United States, 04854
Contact    207-596-8959      
Principal Investigator: Mark Vannorsdall         
United States, Nebraska
Nebraska Nephrology Research Institute, LLC Recruiting
Lincoln, Nebraska, United States, 68510
Contact    402-489-0223      
Principal Investigator: Leslie Spry         
Creighton University Medical Center Recruiting
Omaha, Nebraska, United States, 68131
Contact    402-280-4319      
Principal Investigator: Marc Rendell         
United States, New York
Endocrine Group, LLP Recruiting
Albany, New York, United States, 12206
Contact    518-489-4704      
Principal Investigator: Robert Busch         
Institute for clinical studies Recruiting
Rosedale, New York, United States, 11422
Contact    718-276-4750      
Principal Investigator: David Scott         
Endocrine Associates of Long Island, PC Recruiting
Smithtown, New York, United States, 11787
Contact    631-265-5501      
Principal Investigator: Michael Shanik         
United States, North Carolina
Physicians East Recruiting
Greenville, North Carolina, United States, 27834
Contact    252-413-6392      
Principal Investigator: Mark Warren         
Diabetes & Endocrinology Consultants PC Recruiting
Morehead City, North Carolina, United States, 28557
Contact    252-222-5700      
Principal Investigator: Kathryn Lucas         
Boice Willis Clinic, PA Recruiting
Rocky Mount, North Carolina, United States, 27804
Contact    252-937-0484      
Principal Investigator: Charles Jere         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact    215-955-1978      
Principal Investigator: Serge Jabbour         
Partners in Nephrology & Endocrinology Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact    412-883-4550      
Principal Investigator: Patricia Bononi         
United States, South Carolina
South Carolina Nephrology and Hypertension Center, Inc. Recruiting
Orangeburg, South Carolina, United States, 29118
Contact    808-531-2220      
Principal Investigator: Moustafa Moustafa         
Carolina Diabetes & Kidney Ctr. Sumter Medical Specialist Recruiting
Sumter, South Carolina, United States, 29150
Contact    830-469-7500      
Principal Investigator: Pusadee Suchinda         
United States, Tennessee
Knoxville Kidney Center, PLLC Recruiting
Knoxville, Tennessee, United States, 37923
Contact    865-692-3462      
Principal Investigator: George Newman         
United States, Texas
Center For Clinical Research Recruiting
Austin, Texas, United States, 78758
Contact    512-901-8838      
Principal Investigator: Paul Moore         
Endocrine Associates of Dallas Recruiting
Dallas, Texas, United States, 75231
Contact    214-265-2112      
Principal Investigator: Stephen Aronoff         
Juno Research Recruiting
Houston, Texas, United States, 77036
Contact    281-988-7505      
Principal Investigator: Bernadette Iguh         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact    713-798-0280      
Principal Investigator: Biruh Workeneh         
Endocrine Associates, LLC Recruiting
Houston, Texas, United States, 77004
Contact    713-520-8385      
Principal Investigator: Gerardo Bueso         
The Endocrine Center Recruiting
Houston, Texas, United States, 77079
Contact    281-944-3610      
Principal Investigator: Amer Al Karadsheh         
San Antonio Kidney Disease Center Physicians Group Recruiting
San Antonio, Texas, United States, 78229
Contact    210-692-7864      
Principal Investigator: Susan ` Diamond         
United States, Washington
Providence Health & Services Recruiting
Spokane, Washington, United States, 99220
Contact    509-474-4345      
Principal Investigator: Radica Alicic         
United States, West Virginia
West Virginia School of Medicine Not yet recruiting
Morgantown, West Virginia, United States, 26506
Contact    304-293-2551      
Principal Investigator: Muhammad Mustafa         
Brazil
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. Recruiting
Belem, Brazil, 66073-000
Contact: Eli Lilly         
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. Recruiting
Belo Horizonte, Brazil, 30140-001
Contact: Eli Lilly         
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. Recruiting
Curitiba, Brazil, 80240-000
Contact: Eli Lilly         
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. Recruiting
Juiz De Fora, Brazil, 36036-330
Contact: Eli Lilly         
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. Recruiting
Passo Fundo, Brazil, 99010-080
Contact: Eli Lilly         
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. Recruiting
Porto Alegre, Brazil, 90610000
Contact: Eli Lilly         
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. Recruiting
Santa Catarina, Brazil, 89227680
Contact: Eli Lilly         
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. Recruiting
São Paulo, Brazil, 04025-011
Contact: Eli Lilly         
Hungary
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. Recruiting
Baja, Hungary, 6500
Contact: Eli Lilly         
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. Recruiting
Budapest, Hungary, 1036
Contact: Eli Lilly         
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. Recruiting
Esztergom, Hungary, 2500
Contact: Eli Lilly         
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. Not yet recruiting
Kaposvar, Hungary, 7400
Contact: Eli Lilly         
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. Recruiting
Kecskemet, Hungary, 6000
Contact: Eli Lilly         
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. Recruiting
Pecs, Hungary, 7623
Contact: Eli Lilly         
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. Recruiting
Satoraljaujhely, Hungary, H-3980
Contact: Eli Lilly         
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. Recruiting
Siofok, Hungary, 8600
Contact: Eli Lilly         
Mexico
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. Recruiting
Chihuahua, Mexico, 31000
Contact: Eli Lilly         
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. Recruiting
Culiacan, Mexico, 80030
Contact: Eli Lilly         
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. Recruiting
Guadalajara, Mexico, 44650
Contact: Eli Lilly         
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. Recruiting
Mexico City, Mexico, 11850
Contact: Eli Lilly         
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. Recruiting
Monterrey, Mexico, 64000
Contact: Eli Lilly         
Poland
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. Recruiting
Gdansk, Poland, 80-952
Contact: Eli Lilly         
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. Recruiting
Lodz, Poland, 90302
Contact: Eli Lilly         
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. Recruiting
Szczecin, Poland, 70-111
Contact: Eli Lilly         
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. Recruiting
Zgierz, Poland, 95-100
Contact: Eli Lilly         
Romania
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. Recruiting
Bacau, Romania, 600114
Contact: Eli Lilly         
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. Recruiting
Bucharest, Romania, 020045
Contact: Eli Lilly         
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. Recruiting
Deva, Romania, 330084
Contact: Eli Lilly         
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. Recruiting
Oradea, Romania, 410167
Contact: Eli Lilly         
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. Recruiting
Targu Mures, Romania, 540142
Contact: Eli Lilly         
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. Recruiting
Timisoara, Romania, 300125
Contact: Eli Lilly         
South Africa
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. Recruiting
Cape Town, South Africa, 7925
Contact: Eli Lilly         
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. Recruiting
Durban, South Africa, 4091
Contact: Eli Lilly         
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. Recruiting
Johannesburg, South Africa, 2198
Contact: Eli Lilly         
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. Recruiting
Somerset West, South Africa, 7130
Contact: Eli Lilly         
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. Recruiting
Worcester, South Africa, 6850
Contact: Eli Lilly         
Spain
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. Recruiting
Barcelona, Spain, 08036
Contact: Eli Lilly         
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. Recruiting
Valencia, Spain, 46026
Contact: Eli Lilly         
Ukraine
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. Recruiting
Dnipropetrovsk, Ukraine, 49005
Contact: Eli Lilly         
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. Recruiting
Kyiv, Ukraine, 2091
Contact: Eli Lilly         
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. Recruiting
Lugansk, Ukraine, 91045
Contact: Eli Lilly         
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. Recruiting
Poltava, Ukraine, 36011
Contact: Eli Lilly         
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. Recruiting
Ternopil, Ukraine, 46002
Contact: Eli Lilly         
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: September 2, 2014
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, Type 2
Kidney Diseases
Diabetes Mellitus
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Insulin, Globin Zinc
Glargine
Insulin
Insulin, Long-Acting
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014