A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01191268
First received: August 27, 2010
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Glargine
Drug: LY2189265
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: The Impact of LY2189265 Versus Insulin Glargine in Combination With Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 4)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
    Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.


Secondary Outcome Measures:
  • Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
    Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.

  • Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52 [ Time Frame: 26 weeks and 52 weeks ] [ Designated as safety issue: No ]
    The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.

  • Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia [ Time Frame: Baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: Yes ]
    The percentage of participants achieving HbA1c less than 7.0% without nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking) or severe (episodes requiring the assistance of another person to actively administer resuscitative actions) hypoglycemia was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.

  • Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles [ Time Frame: Baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: No ]
    The self-monitored plasma glucose (SMPG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. The mean of the 8 time points (Daily Mean) was also calculated. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.

  • Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose [ Time Frame: Baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: No ]
    Fasting serum glucose was measured by the central laboratory. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline fasting blood glucose as a covariate.

  • Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine) [ Time Frame: Baseline and 26 weeks and 52 weeks ] [ Designated as safety issue: No ]
    Total daily insulin (TDI) dose was reported at baseline, 26 weeks, and 52 weeks. Daily Insulin Lispro and Insulin Glargine doses were reported at 26 and 52 weeks.

  • Change From Baseline to 26 and 52 Weeks in Body Weight [ Time Frame: Baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: Yes ]
    Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline body weight as a covariate.

  • Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose [ Time Frame: Baseline and 52 weeks and 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI) [ Time Frame: Baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: Yes ]
    Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline BMI as a covariate.

  • Change From Baseline to 26 and 52 Weeks in the EQ-5D [ Time Frame: Baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: No ]
    The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, metformin use, and baseline.

  • Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) [ Time Frame: Baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: No ]
    The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = "not at all difficult" and 1 = "unable to do". The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate.

  • Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) [ Time Frame: Baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: No ]
    The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate.

  • Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS) [ Time Frame: Baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: No ]
    The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate.

  • Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes [ Time Frame: Baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: Yes ]
    Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured.

  • Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose [ Time Frame: Baseline and 52 weeks and 4 weeks after last dose ] [ Designated as safety issue: Yes ]
    Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured at baseline and at 4 weeks after last dose (ALD).

  • Change From Baseline to 26 and 52 Weeks in Serum Calcitonin [ Time Frame: Baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: Yes ]
  • Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose [ Time Frame: Baseline and 52 weeks and 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change From Baseline to 26 and 52 Weeks in Blood Pressure [ Time Frame: Baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: Yes ]
    Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline blood pressure as a covariate.

  • Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose [ Time Frame: Baseline and 52 weeks and 4 weeks after last dose ] [ Designated as safety issue: Yes ]
    Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured.

  • Change From Baseline to 26 and 52 Weeks in Pulse Rate [ Time Frame: Baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: Yes ]
    Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline as a covariate

  • Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose [ Time Frame: Baseline and 52 weeks and 4 weeks after last dose ] [ Designated as safety issue: Yes ]
    Seated pulse rate was measured.

  • Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval [ Time Frame: Baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: Yes ]
    The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate.

  • Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate [ Time Frame: Baseline, 26 weeks, and 52 weeks ] [ Designated as safety issue: Yes ]
    Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate.

  • Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: Yes ]
    The number of adjudicated (by an independent Clinical Endpoint Committee [CEC]) pancreatic events is summarized at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  • Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose [ Time Frame: Baseline through 26 weeks and 52 weeks ] [ Designated as safety issue: Yes ]
    Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The number of participants with self-reported hypoglycemic events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  • Rate of Self-reported Hypoglycemic Events up to 52 Weeks [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: Yes ]
    Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  • Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: Yes ]
    Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  • Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose [ Time Frame: Baseline through 4 weeks after last dose ] [ Designated as safety issue: Yes ]
    A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.

  • Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose [ Time Frame: Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose ] [ Designated as safety issue: Yes ]
    A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks, 52 weeks, and 4 weeks after last dose. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.


Enrollment: 884
Study Start Date: November 2010
Study Completion Date: September 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.5 mg LY2189265

LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks

Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

Drug: LY2189265
Other Name: Dulaglutide
Drug: Insulin Lispro
Experimental: 0.75 mg LY2189265

LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks

Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

Drug: LY2189265
Other Name: Dulaglutide
Drug: Insulin Lispro
Active Comparator: Insulin Glargine

Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks

Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

Drug: Insulin Glargine Drug: Insulin Lispro

Detailed Description:

The term rescue therapy in this trial was defined as therapy for participants who met criteria for persistent severe hyperglycemia and therapy for participants who required new intervention for any other reason. The latter included participants who discontinued study drug due to adverse events, participant decision, or any other reason. For efficacy analyses, participants who received rescue medication were included in the analysis population, but only measurements obtained prior to taking rescue therapy were included in the efficacy analysis. For safety analyses, with the exception of hypoglycemia, all measurements including those obtained after taking rescue therapy were included in the analysis.

  Eligibility

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

Inclusion Criteria:

  • Type 2 diabetes
  • Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications
  • Glycosylated hemoglobin (HbA1c) greater than or equal to 7% and less than or equal to 11%
  • Willing to inject subcutaneous medication
  • Willing to monitor blood glucose levels and adjust insulin dose
  • Willing to maintain a study diary
  • Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)
  • Stable weight for 3 months prior to screening
  • Females of child bearing potential must test negative for pregnancy at screening and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug

Exclusion Criteria:

  • Type 1 Diabetes
  • Previous therapy with glucagon-like peptide 1 (GLP-1) agonists within 3 months prior to screening
  • 1 or more episodes of ketoacidosis within 6 months prior to screening
  • Have been treated with prescription or over the counter medication to promote weight loss within 3 months prior to screening
  • Estimated glomerular filtration rate (eGFR) less than or equal to 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) at screening
  • Taking steroids for greater than 14 days except for topical, eye, nasal, or inhaled
  • History of heart failure, New York Heart Classification III or IV within 2 months prior to screening
  • Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking medications that directly affect GI motility
  • Acute or chronic hepatitis or pancreatitis
  • Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary C-Cell hyperplasia
  • Serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/mL) at screening
  • Organ transplant except cornea
  • Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
  • History of or active malignancy except skin or in situ cervical or prostate cancer within the last 5 years
  • Known drug or alcohol abuse
  • Have enrolled in another clinical trial within the last 30 days
  • Have previously signed an informed consent or participated in a LY2189265 study
  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: NCT01191268

  Hide Study Locations
Locations
United States, California
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Concord, California, United States, 94520
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La Mesa, California, United States, 91942
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Lancaster, California, United States, 93534
United States, Connecticut
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New Britain, Connecticut, United States, 06050
United States, Florida
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Hollywood, Florida, United States, 33021
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Jacksonville, Florida, United States, 32209
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West Palm Beach, Florida, United States, 33401
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Winter Haven, Florida, United States, 33880
United States, Hawaii
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Honolulu, Hawaii, United States, 96813
United States, Indiana
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Indianapolis, Indiana, United States, 46202
United States, Kansas
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Topeka, Kansas, United States, 66606
United States, Kentucky
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Lexington, Kentucky, United States, 40503
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Paducah, Kentucky, United States, 42003
United States, Louisiana
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Metairie, Louisiana, United States, 70006
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New Orleans, Louisiana, United States, 70121
United States, Massachusetts
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Haverhill, Massachusetts, United States, 01830
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Springfield, Massachusetts, United States, 01199
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Waltham, Massachusetts, United States, 02453
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Worcester, Massachusetts, United States, 01605
United States, Minnesota
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Minneapolis, Minnesota, United States, 55416
United States, Missouri
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Chesterfield, Missouri, United States, 63017
United States, New Hampshire
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Nashua, New Hampshire, United States, 03063
United States, New Jersey
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Toms River, New Jersey, United States, 08753
United States, New York
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Albany, New York, United States, 12206
United States, North Carolina
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Asheville, North Carolina, United States, 28803
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Morehead City, North Carolina, United States, 28557
United States, North Dakota
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Fargo, North Dakota, United States, 58103
United States, Oregon
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Eugene, Oregon, United States, 97401
United States, South Carolina
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Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
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Memphis, Tennessee, United States, 38119
United States, Texas
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Austin, Texas, United States, 78731
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Dallas, Texas, United States, 75230
United States, Washington
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Federal Way, Washington, United States, 98003
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Renton, Washington, United States, 98057
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Vancouver, Washington, United States, 98664
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Wenatchee, Washington, United States, 98801
Argentina
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Buenos Aires, Argentina, C1034ACO
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Cipolletti, Argentina, 8324
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Mendoza, Argentina, M5500CCE
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Salta, Argentina, 4406
Australia, South Australia
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Keswick, South Australia, Australia, 5035
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Melbourne, Victoria, Australia, 3004
Belgium
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Bonheiden, Belgium, 2820
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Brussels, Belgium, 1070
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Genk, Belgium, 3600
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Liège, Belgium, 4000
Brazil
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Belem, Brazil, 66073-000
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Fortaleza, Brazil, 60430-350
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Porto Alegre, Brazil, 90035-170
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São Paulo, Brazil, 04266-010
Canada, British Columbia
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New Westminster, British Columbia, Canada, V3L 3W5
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
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London, Ontario, Canada, N6G 4X8
Canada, Quebec
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Gatineau, Quebec, Canada, J8V 2P5
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Sherbrooke, Quebec, Canada, J1G 5K2
Denmark
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Aarhus, Denmark, 8000
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Hillerod, Denmark, Dk-3400
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Kobenhavn, Denmark, 2400
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Koege, Denmark, 4600
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Kolding, Denmark, 6000
Greece
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Ampelokipoi, Greece, 11527
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Athens, Greece, 11527
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Nikaias - Piraeus, Greece, 18454
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Thessaloniki, Greece, 54639
Hungary
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Bekescsaba, Hungary, 5600
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Budapest, Hungary, 1115
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Gyongyos, Hungary, 3200
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Miskolc, Hungary, 3529
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Nagykanizsa, Hungary, 8800
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Nyiregyhaza, Hungary, 4400
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Papa, Hungary, 8500
Mexico
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Culiacan, Mexico, 80020
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Guadalajara, Mexico, 44650
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Merida, Mexico, 97070
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Monterrey, Mexico, 64461
Poland
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Gdynia, Poland, 81-557
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Lodz, Poland, 90-242
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Radzymin, Poland, 05-250
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Wroclaw, Poland, 50-349
Puerto Rico
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Manati, Puerto Rico, 00674
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Ponce, Puerto Rico, 00728
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San Juan, Puerto Rico, 00917-3104
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Yabucoa, Puerto Rico, 00767
Russian Federation
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Moscow, Russian Federation, 127486
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Saint Petersburg, Russian Federation, 191126
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Samara, Russian Federation, 443095
Spain
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Barcelona, Spain, 08022
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Madrid, Spain, 28046
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Palma De Mallorca, Spain, 07010
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Pozuelo De Alarcon, Spain, 28223
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Teruel, Spain, 44002
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Valencia, Spain, 46014
Sweden
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Karlstad, Sweden, 65185
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Lund, Sweden, 22185
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Stockholm, Sweden, 113 61
Taiwan
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Kaohsiung, Taiwan, 807
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Sindian City, Taiwan, 23148
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Taichung, Taiwan, 404
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Taipei, Taiwan, 11031
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Yong Kang City, Taiwan, 710
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: NCT01191268     History of Changes
Other Study ID Numbers: 11376, H9X-MC-GBDD
Study First Received: August 27, 2010
Results First Received: October 3, 2014
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Australia: National Health and Medical Research Council
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: Ministry of Health
Canada: Health Canada
Denmark: Danish Medicines Agency
Greece: Ministry of Health and Welfare
Hungary: Institutional Ethics Committee
Mexico: Ministry of Health
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
South Africa: Human Research Ethics Committee
Spain: Ministry of Health
Taiwan: Center for Drug Evaluation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Insulin Lispro
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014