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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01075282




Trial ID
NCT01075282
Ethics application status
Date submitted
23/02/2010
Date registered
23/02/2010
Date last updated
15/01/2015

Titles & IDs
Public title
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-2)
Scientific title
A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride
Secondary ID [1] 0 0
H9X-MC-GBDB
Secondary ID [2] 0 0
11374
Universal Trial Number (UTN)
Trial acronym
AWARD-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Insulin Glargine
Treatment: Drugs - LY2189265
Treatment: Drugs - Metformin
Treatment: Drugs - Glimepiride

Experimental: LY2189265 1.5 mg - LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks

Experimental: LY2189265 0.75 mg - LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks

Active Comparator: Insulin Glargine - Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks


Treatment: Drugs: Insulin Glargine


Treatment: Drugs: LY2189265


Treatment: Drugs: Metformin


Treatment: Drugs: Glimepiride


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) - Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.
Timepoint [1] 0 0
Baseline, 52 weeks
Secondary outcome [1] 0 0
Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) - Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.
Timepoint [1] 0 0
Baseline, 26 weeks, and 78 weeks
Secondary outcome [2] 0 0
Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks - Number of participants achieving HbA1c levels less than 7.0% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.
Timepoint [2] 0 0
26, 52, and 78 weeks
Secondary outcome [3] 0 0
Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks - Number of participants achieving HbA1c levels less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.
Timepoint [3] 0 0
26, 52, and 78 weeks
Secondary outcome [4] 0 0
Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles - The self-monitored blood glucose (SMBG) 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 3 AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (Daily Mean) were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Timepoint [4] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [5] 0 0
Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S) - The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (ß)-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-B and HOMA-2S were set at 100%. Least Squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Timepoint [5] 0 0
Baseline, 52, and 78 weeks
Secondary outcome [6] 0 0
Change From Baseline to 52 and 78 Weeks in Glucagon Concentration - Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Timepoint [6] 0 0
Baseline, 52, and 78 weeks
Secondary outcome [7] 0 0
Change From Baseline to 26, 52 and 78 Weeks for Body Weight - Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Timepoint [7] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [8] 0 0
Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index - Body mass index (BMI) 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, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Timepoint [8] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [9] 0 0
Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension - The European Quality of Life - 5 dimensions (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 of the questionnaire consists of a 100-mm 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) and adjusted by treatment, country, and baseline.
Timepoint [9] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [10] 0 0
Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living - 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 and treatment as fixed effects and baseline as a covariate.
Timepoint [10] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [11] 0 0
Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception - 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 and treatment as fixed effects and baseline as a covariate.
Timepoint [11] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [12] 0 0
Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey - 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 and treatment as fixed effects and baseline as a covariate.
Timepoint [12] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [13] 0 0
Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 Weeks - 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, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Timepoint [13] 0 0
26, 52, and 78 weeks
Secondary outcome [14] 0 0
Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks - Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer 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), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Timepoint [14] 0 0
Baseline through 26, 52, and 78 weeks
Secondary outcome [15] 0 0
Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks - Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer 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), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Timepoint [15] 0 0
Baseline through 26, 52, and 78 weeks
Secondary outcome [16] 0 0
Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks - Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26, 52, and 78 weeks.
Timepoint [16] 0 0
26, 52, and 78 weeks
Secondary outcome [17] 0 0
Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes - Amylase (total and pancreas-derived) and lipase concentrations were measured.
Timepoint [17] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [18] 0 0
Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks - The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Timepoint [18] 0 0
Baseline through 26, 52, and 78 weeks
Secondary outcome [19] 0 0
Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin
Timepoint [19] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [20] 0 0
Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks - Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. 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. The number of participants with adjudicated CV events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Timepoint [20] 0 0
Baseline through 26, 52, and 78 weeks
Secondary outcome [21] 0 0
Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate - Sitting 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, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Timepoint [21] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [22] 0 0
Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure - Sitting systolic blood pressure (SBP) and sitting 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, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Timepoint [22] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [23] 0 0
Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate - 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, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Timepoint [23] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [24] 0 0
Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval - 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, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Timepoint [24] 0 0
Baseline, 26, 52, and 78 weeks
Secondary outcome [25] 0 0
Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum) - LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26, 52, and 78 weeks, and at the safety follow-up visit 30 days after study drug discontinuation (83 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.
Timepoint [25] 0 0
Baseline, 26, 52, 78, and 83 weeks

Eligibility
Key inclusion criteria
- Type 2 Diabetes not well controlled on 1, 2, or 3 oral antidiabetic medications (at
least one of them must be metformin and/or a sulfonylurea)

1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal
to 11 if taking 1 oral antidiabetic medication

2. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral
antidiabetic medications

- Accept treatment with metformin and glimepiride throughout the study, as per protocol

- Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for
Insulin Glargine.

- Stable weight for 3 months prior to screening

- Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)

- Females of child bearing potential must test negative for pregnancy at screening by
serum pregnancy test 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Type 1 Diabetes

- HbA1c equal to or less than 6.5 at randomization

- Chronic insulin use

- Taking drugs to promote weight loss by prescription or over the counter

- Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or
inhaled

- History of Heart Failure New York Heart Classification III or IV, or acute myocardial
infarction, or stroke within 2 months of screening

- Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery
(stomach stapling) or chronically taking drugs that directly affect GI motility

- Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper
normal limit

- Acute or chronic pancreatitis of any form

- Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5
milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for
females, or a creatinine clearance of less than 60 milliliters per minute (ml/min)

- History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B)
or medullary c-cell hyperplasia or thyroid cancer

- A serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/ml) at
screening

- Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis

- History of or active malignancy except skin or in situ cervical or prostate cancer for
within last 5 years

- Sickle cell, hemolytic anemia, or other hematological condition that may interfere
with HbA1c testing

- Organ transplant except cornea

- Have enrolled in another clinical trial within the last 30 days

- Have previously signed an informed consent or participated in a LY2189265 study

- Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months
prior to screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
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. - Wollongong
Recruitment hospital [2] 0 0
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. - Brisbane
Recruitment hospital [3] 0 0
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. - Keswick
Recruitment hospital [4] 0 0
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. - East Ringwood
Recruitment hospital [5] 0 0
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. - Heidelberg
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
5035 - Keswick
Recruitment postcode(s) [4] 0 0
3135 - East Ringwood
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Caba
Country [3] 0 0
Argentina
State/province [3] 0 0
Córdoba
Country [4] 0 0
Argentina
State/province [4] 0 0
Mendoza
Country [5] 0 0
Belgium
State/province [5] 0 0
Gribomont
Country [6] 0 0
Belgium
State/province [6] 0 0
Halen
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Brazil
State/province [8] 0 0
Joinville
Country [9] 0 0
Brazil
State/province [9] 0 0
São Paulo
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Manitoba
Country [13] 0 0
Canada
State/province [13] 0 0
Newfoundland and Labrador
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Croatia
State/province [16] 0 0
Osijek
Country [17] 0 0
Croatia
State/province [17] 0 0
Slavonski Brod
Country [18] 0 0
Croatia
State/province [18] 0 0
Zagreb
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Holesov
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Prague
Country [21] 0 0
France
State/province [21] 0 0
Corbeil-Essonnes
Country [22] 0 0
France
State/province [22] 0 0
Dijon
Country [23] 0 0
France
State/province [23] 0 0
Nantes
Country [24] 0 0
France
State/province [24] 0 0
Pessac
Country [25] 0 0
France
State/province [25] 0 0
Tours
Country [26] 0 0
Greece
State/province [26] 0 0
Athens
Country [27] 0 0
Hungary
State/province [27] 0 0
Budapest
Country [28] 0 0
Hungary
State/province [28] 0 0
Mako
Country [29] 0 0
Hungary
State/province [29] 0 0
Mosonmagyarovar
Country [30] 0 0
Hungary
State/province [30] 0 0
Szekesfehervar
Country [31] 0 0
India
State/province [31] 0 0
Aligarh
Country [32] 0 0
India
State/province [32] 0 0
Bangalore
Country [33] 0 0
India
State/province [33] 0 0
Chennai
Country [34] 0 0
India
State/province [34] 0 0
Indore
Country [35] 0 0
India
State/province [35] 0 0
Jaipur
Country [36] 0 0
India
State/province [36] 0 0
Mumbai
Country [37] 0 0
India
State/province [37] 0 0
Patna
Country [38] 0 0
Italy
State/province [38] 0 0
Firenze
Country [39] 0 0
Italy
State/province [39] 0 0
Milano
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Bucheon
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Ilsan
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Pusan
Country [43] 0 0
Mexico
State/province [43] 0 0
Coatzacoalcos
Country [44] 0 0
Mexico
State/province [44] 0 0
Cuernavaca
Country [45] 0 0
Mexico
State/province [45] 0 0
Guadalajara
Country [46] 0 0
Mexico
State/province [46] 0 0
Monterrey
Country [47] 0 0
Poland
State/province [47] 0 0
Bialystok
Country [48] 0 0
Poland
State/province [48] 0 0
Bydogoszcz
Country [49] 0 0
Poland
State/province [49] 0 0
Krakow
Country [50] 0 0
Poland
State/province [50] 0 0
Szczecin
Country [51] 0 0
Poland
State/province [51] 0 0
Warsaw
Country [52] 0 0
Poland
State/province [52] 0 0
Wroclaw
Country [53] 0 0
Romania
State/province [53] 0 0
Baia Mare
Country [54] 0 0
Romania
State/province [54] 0 0
Bucharest
Country [55] 0 0
Romania
State/province [55] 0 0
Galati
Country [56] 0 0
Romania
State/province [56] 0 0
Oradea
Country [57] 0 0
Slovakia
State/province [57] 0 0
Kosice
Country [58] 0 0
Spain
State/province [58] 0 0
Alicante
Country [59] 0 0
Spain
State/province [59] 0 0
Avila
Country [60] 0 0
Spain
State/province [60] 0 0
Palencia
Country [61] 0 0
Spain
State/province [61] 0 0
Requena
Country [62] 0 0
Sweden
State/province [62] 0 0
Göteborg
Country [63] 0 0
Sweden
State/province [63] 0 0
Helsingborg
Country [64] 0 0
Sweden
State/province [64] 0 0
Lund
Country [65] 0 0
Sweden
State/province [65] 0 0
Stockholm
Country [66] 0 0
Taiwan
State/province [66] 0 0
Chiayi City
Country [67] 0 0
Taiwan
State/province [67] 0 0
Kaohsiung
Country [68] 0 0
Taiwan
State/province [68] 0 0
Tainan
Country [69] 0 0
Taiwan
State/province [69] 0 0
Taipei
Country [70] 0 0
Taiwan
State/province [70] 0 0
Tao-Yuan
Country [71] 0 0
Taiwan
State/province [71] 0 0
Yung-Kang, Tainan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin
A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes.
Participants must also be taking metformin and glimepiride.
Trial website
https://clinicaltrials.gov/show/NCT01075282
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries