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

August 27, 2010
October 3, 2014
November 2010
February 2012   (final data collection date for primary outcome measure)
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.
Change from baseline to 26 weeks endpoint in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01191268 on ClinicalTrials.gov Archive Site
  • 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.
  • Change from baseline to 52 weeks endpoint in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks for blood glucose values from the 8-point self-monitored blood glucose(SMBG) profiles [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients attaining HbA1c less than 7% and less than or equal to 6.5% at weeks 26 and 52 [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, 52 weeks, and 4 weeks after last dose for body weight [ Time Frame: Baseline, 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 and 52 weeks in total daily insulin lispro dose [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks in the EuroQoL5 [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • 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, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks in the Impact of Weight on Self-Perception (IW-SP) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks in the Low Blood Sugar Survey (LBSS) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks, and 4 weeks after last dose on blood pressure [ Time Frame: Baseline, 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Number of events of pancreatitis at 26 and 52 weeks, and 4 weeks after last dose [ Time Frame: 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 and 52 weeks, and 4 weeks after last dose on pancreatic enzymes [ Time Frame: Baseline, 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 weeks and 52 weeks, and 4 weeks after last dose on serum calcitonin [ Time Frame: Baseline, 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Number of self-reported hypoglycemic events at 26 weeks and 52 weeks, and 4 weeks after last dose [ Time Frame: 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Presence of LY2189265 antibodies at 26 weeks and 52 weeks and 4 weeks after last dose [ Time Frame: 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 , 52, and 4 weeks after last dose in Body Mass Index (BMI) [ Time Frame: Baseline, 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 weeks and 52 weeks in fasting blood glucose [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks in the percentage of patients achieving HbA1c <7% without nocturnal hypoglycemia [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)
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)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Insulin Glargine
  • Drug: LY2189265
    Other Name: Dulaglutide
  • Drug: Insulin Lispro
  • 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

    Interventions:
    • Drug: LY2189265
    • 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

    Interventions:
    • Drug: LY2189265
    • 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

    Interventions:
    • Drug: Insulin Glargine
    • 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
884
September 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States,   Argentina,   Australia,   Belgium,   Brazil,   Taiwan,   Denmark,   Greece,   Hungary,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   Spain,   Sweden
 
NCT01191268
11376, H9X-MC-GBDD
No
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
October 2014

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