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CompletedNCT00942188Updated Sep 18, 2019Results posted

A Study of LY2189102 in Patients With Type 2 Diabetes

A Phase 2 interventional study of LY2189102 and Placebo in Type 2 Diabetes, sponsored by Eli Lilly and Company. Completed at 18 sites in United States. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-09-18.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

Study to evaluate the safety, tolerability and efficacy of LY2189102 in patients with type 2 diabetes.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Diabetes
  • Type 2 Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 106 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Have Type 2 Diabetes and confirmed by fasting C-peptide levels greater than or equal to 0.8 nanograms per milliliter [ng/ml]), with duration of more than 3 months.
  • Body mass index between 25 and 40 kilograms per square meter (kg/m2).
  • Stable on diet and exercise alone, with or without metformin monotherapy (stable regimen or dose for at least 8 weeks).
  • Drug-naïve or previous anti-diabetic pharmacotherapy use is allowed (for the latter, patient must have stopped taking pharmacotherapy greater than 12 weeks prior to screening and only if deemed appropriate by the investigator).
  • Angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, thiazide diuretics or calcium channel blockers are permitted for the treatment of hypertension or proteinuria.
  • Glycated hemoglobin level between 7% and 10%.
  • Baseline High-sensitivity C-reactive protein greater than or equal to 2 milligrams per liter (mg/L)
  • Females of childbearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must test negative for pregnancy at the time of enrollment based on a pregnancy test. Furthermore, sexually active female and male participants must agree to use 2 reliable methods of birth control during the study and for 3 months following the last dose of study drug.
  • Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.

Exclusion criteria

Exclusion Criteria:

  • Current use of anti-diabetic pharmacotherapy (except metformin, under conditions specified in Inclusion Criteria above).
  • Current treatment with anti-inflammatory drugs, including corticosteroids and non-steroidal anti-inflammatory drugs (100 mg per day or less of aspirin allowed).
  • Within 60 days of the initial dose of the study drug, have received treatment with a drug that has not received regulatory approval for any indication.
  • Presence of autoantibodies to glutamic acid decarboxylase 65 or islet-cell autoantibody-2.
  • Evidence of tuberculosis as documented by a specific assay, medical history, and chest x-ray. A specific assay, (for example, tuberculin testing) will be conducted unless it is medically inappropriate. Exceptions include patients with a history of a positive specific assay for TB who have been treated with isonicotinyl hydrazine (documented) for at least 6 months, or patients with a previous diagnosis of TB who have been appropriately treated and can provide documentation.
  • Symptomatic herpes zoster within 3 months of randomization.
  • Show evidence of hepatitis C and/or positive hepatitis B surface antigen.
  • Show evidence of human immunodeficiency virus and/or positive test of antibodies to human immunodeficiency virus (HIV).
  • Received live or attenuated vaccine(s) within the previous 3 months prior to randomization or will receive within 3 months from the end of study.
  • Screening serum creatinine greater than 2.0 milligrams per deciliter (mg/dL).
  • Serum aspartate aminotransferase or alanine aminotransaminase concentration greater than 2x the upper limit of normal.
  • Known allergies to LY2189102 or excipients.
  • Previously completed or withdrawn from this study or any other study investigating LY2189102.
  • Have donated blood of greater than 500 mL within the preceding 30 days and intend to donate within 3 months from the end of study.
  • Have had other recent or ongoing signs of infection (for example, fever, current treatment with antibiotics).
  • Experienced a serious bacterial infection within 6 months of randomization.
  • Have a serious medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, or neurological disease, or any clinically significant laboratory abnormality.
  • Have had lymphoma, leukemia, or any non-breast malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease.
  • Have had a previous reaction to other biologics that, in the opinion of the investigator, puts the patient at serious risk.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
106 participants (actual)

Study arms

  • Experimental
    0.6 milligrams (mg) LY2189102

    Drug: LY2189102

  • Experimental
    18 mg LY2189102

    Drug: LY2189102

  • Experimental
    180 mg LY2189102

    Drug: LY2189102

  • Placebo comparator
    Placebo

    0.9% Sodium Chloride

    Drug: Placebo

Interventions

  • DrugLY2189102

    Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.

  • DrugPlacebo

    Participants received 2 SC injections weekly for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks

    Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline HbA1c as a continuous covariate.

    Time frame: Baseline, 12 weeks

Secondary outcomes

  1. Change From Baseline in Fasting Glucose at 12 Weeks

    Change in fasting glucose following 12 weeks of therapy (that is, fasting glucose at week 12 minus fasting glucose at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.

    Time frame: Baseline, 12 weeks

  2. Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks

    Change in serum fasting insulin from baseline to endpoint (that is, serum insulin at week 12 minus serum insulin at week 0). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.

    Time frame: Baseline, 12 weeks

  3. Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks

    The number of participants with a change from baseline in glucose and insulin at 2 hours after the MMTT was analyzed. The MMTT measures glucose and insulin before and after a standardized meal is eaten. Glucose and insulin levels were measured before the MMTT and 2 hours after the MMTT.

    Time frame: Baseline, 12 weeks

  4. Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12

    The change from baseline in HbA1c at week 10 (that is HbA1c at week 10 minus HbA1c at baseline) and week 12 (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.

    Time frame: Baseline, week 10, week 12

  5. Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks)

    The Cmax value measures the maximum serum concentration and is estimated for LY2189102. The values were generated as individual estimates from a population pharmacokinetics (PK) model. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug.

    Time frame: Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose

  6. PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks)

    Individual estimates of AUCtau at end of dosing generated from a population pharmacokinetic (PK) model.

    Time frame: Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose

  7. Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks)

    Pharmacokinetics Measured by Serum Concentration at End of Dosing.

    Time frame: Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose

07

Results

Posted Mar 13, 2018

Participant flow

Participant flow — Overall Study
Milestone0.6 mg LY218910218 mg LY2189102180 mg LY2189102Placebo
Started26262727
Completed22161823
Not completed41094
Withdrew: Adverse event0320
Withdrew: Lack of efficacy0001
Withdrew: Protocol violation1100
Withdrew: Lost to follow-up2120
Withdrew: Withdrawal by subject1342
Withdrew: Physician decision0010
Withdrew: Sponsor decision0201

Outcome measures

PrimaryChange From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks

Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline HbA1c as a continuous covariate.

Time frame:
Baseline, 12 weeks
Reported as:
Least squares mean · percentage of glycosylated hemoglobin
Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks
percentage of glycosylated hemoglobin0.6 mg LY218910218 mg LY2189102180 mg LY2189102Placebo
Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks-0.457 ± 0.1454-0.561 ± 0.1530-0.428 ± 0.1379-0.183 ± 0.1315
SecondaryChange From Baseline in Fasting Glucose at 12 Weeks

Change in fasting glucose following 12 weeks of therapy (that is, fasting glucose at week 12 minus fasting glucose at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.

Time frame:
Baseline, 12 weeks
Reported as:
Least squares mean · millimole per liter (mmol/L)
Change From Baseline in Fasting Glucose at 12 Weeks
millimole per liter (mmol/L)0.6 mg LY218910218 mg LY2189102180 mg LY2189102Placebo
Change From Baseline in Fasting Glucose at 12 Weeks-0.873 ± 0.4802-1.270 ± 0.5299-0.629 ± 0.4591-0.019 ± 0.4404
Statistical analysis
  • 0.6 mg LY2189102 vs Placebo · ANCOVA · Ls mean difference: -0.854 · 95% CI -1.94 to 0.23
  • 18 mg LY2189102 vs Placebo · ANCOVA · Ls mean difference: -1.252 · 95% CI -2.48 to -0.03
  • 180 mg LY2189102 vs Placebo · ANCOVA · Ls mean difference: -0.610 · 95% CI -1.76 to 0.54
SecondaryChange From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks

Change in serum fasting insulin from baseline to endpoint (that is, serum insulin at week 12 minus serum insulin at week 0). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.

Time frame:
Baseline, 12 weeks
Reported as:
Least squares mean · microinternational Units per liter
Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks
microinternational Units per liter0.6 mg LY218910218 mg LY2189102180 mg LY2189102Placebo
Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks-1.589 ± 2.9549-0.918 ± 3.3206-0.229 ± 2.78361.405 ± 2.8722
Statistical analysis
  • 0.6 mg LY2189102 vs Placebo · ANCOVA · Ls mean difference: -2.995 · 95% CI -9.82 to 3.83
  • 18 mg LY2189102 vs Placebo · ANCOVA · Ls mean difference: -2.324 · 95% CI -10.21 to 5.56
  • 180 mg LY2189102 vs Placebo · ANCOVA · Ls mean difference: -1.635 · 95% CI -9.16 to 5.89
SecondaryNumber of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks

The number of participants with a change from baseline in glucose and insulin at 2 hours after the MMTT was analyzed. The MMTT measures glucose and insulin before and after a standardized meal is eaten. Glucose and insulin levels were measured before the MMTT and 2 hours after the MMTT.

Time frame:
Baseline, 12 weeks
Reported as:
Number · participants
Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks
participants0.6 mg LY218910218 mg LY2189102180 mg LY2189102Placebo
Glucose at 2 hours22171824
Insulin at 2 hours22171824
SecondaryChange From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12

The change from baseline in HbA1c at week 10 (that is HbA1c at week 10 minus HbA1c at baseline) and week 12 (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.

Time frame:
Baseline, week 10, week 12
Reported as:
Least squares mean · percentage glycosylated hemoglobin
Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12
percentage glycosylated hemoglobin0.6 mg LY218910218 mg LY2189102180 mg LY2189102Placebo
HbA1c at Week 10-0.456 ± 0.1459-0.555 ± 0.1541-0.413 ± 0.1412-0.186 ± 0.1322
HbA1c at Week 12-0.459 ± 0.1560-0.588 ± 0.1712-0.413 ± 0.1455-0.192 ± 0.1410
Statistical analysis
  • 0.6 mg LY2189102 vs Placebo · ANCOVA · Ls mean difference: -0.270 · 95% CI -0.59 to 0.05
  • 18 mg LY2189102 vs Placebo · ANCOVA · Ls mean difference: -0.369 · 95% CI -0.74 to 0.00
  • 180 mg LY2189102 vs Placebo · ANCOVA · Ls mean difference: -0.227 · 95% CI -0.59 to 0.13
  • 0.6 mg LY2189102 vs Placebo · ANCOVA · Ls mean difference: -0.267 · 95% CI -0.61 to 0.08
  • 18 mg LY2189102 vs Placebo · ANCOVA · Ls mean difference: -0.396 · 95% CI -0.79 to 0.00
  • 180 mg LY2189102 vs Placebo · ANCOVA · Ls mean difference: -0.221 · 95% CI -0.59 to 0.15
SecondaryPharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks)

The Cmax value measures the maximum serum concentration and is estimated for LY2189102. The values were generated as individual estimates from a population pharmacokinetics (PK) model. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug.

Time frame:
Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose
Reported as:
Mean · nanograms per milliliter (ng/mL)
Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks)
nanograms per milliliter (ng/mL)0.6 mg LY218910218 mg LY2189102180 mg LY2189102
Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks)269.39 ± 88.236094.67 ± 2153.0039994.74 ± 17880.45
SecondaryPK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks)

Individual estimates of AUCtau at end of dosing generated from a population pharmacokinetic (PK) model.

Time frame:
Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose
Reported as:
Mean · nanogram*hour per milliliter (ng*h/mL)
PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks)
nanogram*hour per milliliter (ng*h/mL)0.6 mg LY218910218 mg LY2189102180 mg LY2189102
PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks)45777.78 ± 14933.09986533.33 ± 340965.836555789.47 ± 2934693.46
SecondaryPharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks)

Pharmacokinetics Measured by Serum Concentration at End of Dosing.

Time frame:
Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose
Reported as:
Mean · nanograms per milliliter (ng/mL)
Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks)
nanograms per milliliter (ng/mL)0.6 mg LY218910218 mg LY2189102180 mg LY2189102
Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks)252.83 ± 83.285532.00 ± 1991.2835815.79 ± 15961.46

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
0.6 mg LY2189102—1/26 (3.8%)19/26 (73.1%)
18 mg LY2189102—1/26 (3.8%)19/26 (73.1%)
180 mg LY2189102—0/27 (0%)23/27 (85.2%)
Placebo—0/27 (0%)20/27 (74.1%)
Most frequent serious events
Most frequent serious events
Event0.6 mg LY218910218 mg LY2189102180 mg LY2189102Placebo
Chest painGeneral disorders0/261/260/270/27
MigraineNervous system disorders1/260/260/270/27
AsthmaRespiratory, thoracic and mediastinal disorders0/261/260/270/27
Status asthmaticusRespiratory, thoracic and mediastinal disorders0/261/260/270/27
Most frequent other events
Showing 10 of 26
Most frequent other events
Event0.6 mg LY218910218 mg LY2189102180 mg LY2189102Placebo
NasopharyngitisInfections and infestations5/263/260/271/27
Injection site haematomaGeneral disorders0/264/260/271/27
HeadacheNervous system disorders1/264/263/272/27
DiarrhoeaGastrointestinal disorders2/263/262/273/27
Injection site irritationGeneral disorders0/263/261/270/27
ArthralgiaMusculoskeletal and connective tissue disorders1/263/263/271/27
NauseaGastrointestinal disorders2/262/261/273/27
VomitingGastrointestinal disorders1/261/260/273/27
PalpitationsCardiac disorders2/261/260/270/27
Abdominal tendernessGastrointestinal disorders0/262/260/271/27

Baseline characteristics

Age, Continuous
Age, Continuous(years)0.6 mg LY218910218 mg LY2189102180 mg LY2189102PlaceboTotal
Mean52.9 ± 6.7553.7 ± 10.7451.3 ± 9.1752.9 ± 9.4152.7 ± 9.05
Sex: Female, Male
Sex: Female, Male(Participants)0.6 mg LY218910218 mg LY2189102180 mg LY2189102PlaceboTotal
Female1517152067
Male11912739
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)0.6 mg LY218910218 mg LY2189102180 mg LY2189102PlaceboTotal
Caucasian612101038
African363315
Hispanic157131449
East Asian01001
Other20103
Region of Enrollment
Region of Enrollment(Participants)0.6 mg LY218910218 mg LY2189102180 mg LY2189102PlaceboTotal
United States26262727106
Percentage of Glycosylated Fraction of Hemoglobin (HbA1c)
Percentage of Glycosylated Fraction of Hemoglobin (HbA1c)(percentage of glycosylated hemoglobin)0.6 mg LY218910218 mg LY2189102180 mg LY2189102PlaceboTotal
Mean7.540 ± 0.55967.950 ± 0.70028.271 ± 0.93807.824 ± 0.65577.882 ± 0.7544
Fasting Glucose
Fasting Glucose(millimoles per liter (mmol/L))0.6 mg LY218910218 mg LY2189102180 mg LY2189102PlaceboTotal
Mean8.152 ± 1.81549.106 ± 2.200110.300 ± 2.14409.339 ± 1.73159.208 ± 2.0688
Fasting Insulin
Fasting Insulin(microinternational units per milliliter)0.6 mg LY218910218 mg LY2189102180 mg LY2189102PlaceboTotal
Mean15.083 ± 12.056215.034 ± 6.938313.989 ± 14.407615.120 ± 12.525314.821 ± 11.7856
High-sensitivity C-reactive Protein (hsCRP)
High-sensitivity C-reactive Protein (hsCRP)(milligrams per liter (mg/L))0.6 mg LY218910218 mg LY2189102180 mg LY2189102PlaceboTotal
Mean6.214 ± 6.21796.024 ± 4.49567.183 ± 6.96916.093 ± 4.52896.373 ± 5.5685

3 further baseline measures are reported on the registry.

08

Study locations

18 sites
  • 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.
    Mobile, Alabama 36689, United States
  • 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.
    Anaheim, California 92801, United States
  • 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.
    Chula Vista, California 91911, United States
  • 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.
    La Mesa, California 91942, United States
  • 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.
    Walnut Creek, California 94598, United States
  • 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.
    Washington, District of Columbia 20003, United States
  • 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.
    Miami Gardens, Florida 33169, United States
  • 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.
    Miami, Florida 33169, United States
  • 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.
    Boise, Idaho 83702, United States
  • 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.
    Baltimore, Maryland 21287, United States
  • 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.
    Dearborn, Michigan 48126, United States
  • 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.
    Philadelphia, Pennsylvania 19107, United States
  • 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.
    Arlington, Texas 76014, United States
  • 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.
    Dallas, Texas 75230, United States
  • 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.
    San Antonio, Texas 78229, United States
  • 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.
    Tomball, Texas 77375, United States
  • 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.
    Salt Lake City, Utah 84107, United States
  • 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.
    Richmond, Virginia 23294, United States
09

References and documents

Publications

  • Bihorel S, Fiedler-Kelly J, Ludwig E, Sloan-Lancaster J, Raddad E. Population pharmacokinetic modeling of LY2189102 after multiple intravenous and subcutaneous administrations. AAPS J. 2014 Sep;16(5):1009-17. doi: 10.1208/s12248-014-9623-6. Epub 2014 Jun 11. PubMed 24912797 ↗

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00942188
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Jul 20, 2009
Start date
Jun 2009
Primary completion
Nov 2010
Completion
Nov 2010
Results posted
Mar 13, 2018
Last update
Sep 18, 2019

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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Other studies from this sponsor

Eli Lilly and Company

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