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A Study of LY2189265 in Japanese Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01001104
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : September 28, 2015
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: LY2189265
Drug: Placebo
Enrollment 145
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 0.75 mg LY2189265 0.5 mg LY2189265 0.25 mg LY2189265 Placebo
Hide Arm/Group Description Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks. Administered by SC injection, QW for 12 weeks. Administered by SC injection, QW for 12 weeks. Administered by SC injection, QW for 12 weeks.
Period Title: Overall Study
Started 35 37 36 37
Completed 33 36 35 34
Not Completed 2 1 1 3
Reason Not Completed
Adverse Event             2             1             0             0
Lost to Follow-up             0             0             1             0
Entry Criteria Not Met             0             0             0             1
Withdrawal by Subject             0             0             0             2
Arm/Group Title 0.75 mg LY2189265 0.5 mg LY2189265 0.25 mg LY2189265 Placebo Total
Hide Arm/Group Description Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks. Administered by SC injection, QW for 12 weeks. Administered by SC injection, QW for 12 weeks. Administered by SC injection, QW for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 35 37 36 37 145
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 37 participants 36 participants 37 participants 145 participants
52.23  (7.80) 52.50  (9.17) 52.26  (8.82) 51.70  (9.67) 52.17  (8.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 37 participants 36 participants 37 participants 145 participants
Female
7
  20.0%
14
  37.8%
9
  25.0%
8
  21.6%
38
  26.2%
Male
28
  80.0%
23
  62.2%
27
  75.0%
29
  78.4%
107
  73.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Japanese Number Analyzed 35 participants 37 participants 36 participants 37 participants 145 participants
35 37 36 37 145
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 35 participants 37 participants 36 participants 37 participants 145 participants
35 37 36 37 145
Percentage of Glycosylated Hemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of glycosylated hemoglobin
Number Analyzed 35 participants 37 participants 36 participants 37 participants 145 participants
8.01  (0.63) 7.98  (0.66) 8.05  (0.66) 7.98  (0.64) 8.00  (0.64)
Fasting Blood Glucose (FBG)  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter (mg/dL)
Number Analyzed 35 participants 37 participants 36 participants 37 participants 145 participants
156.51  (26.43) 150.95  (29.31) 158.75  (35.62) 159.65  (33.29) 156.45  (31.26)
1.Primary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks
Hide Description Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). Changes in HbA1c were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 dose of the study drug.
Arm/Group Title 0.75 mg LY2189265 0.5 mg LY2189265 0.25 mg LY2189265 Placebo
Hide Arm/Group Description:
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Overall Number of Participants Analyzed 34 37 36 36
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage glycosylated hemoglobin
-1.35
(-1.53 to -1.18)
-1.15
(-1.32 to -0.98)
-0.90
(-1.07 to -0.73)
-0.18
(-0.36 to -0.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, 0.5 mg LY2189265, 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments This is the p-value for the linear trend test at 12 weeks.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.5 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.17
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks
Hide Description Percentage of participants who achieved HbA1c<7% up to the 12-week endpoint.
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF).
Arm/Group Title 0.75 mg LY2189265 0.5 mg LY2189265 0.25 mg LY2189265 Placebo
Hide Arm/Group Description:
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Overall Number of Participants Analyzed 35 37 36 37
Measure Type: Number
Unit of Measure: percentage of participants
77.1 59.5 47.2 10.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, 0.5 mg LY2189265, 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This is the p-value from the Cochran-Armitage trend test.
Method Cochran-Armitage
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.5 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks
Hide Description Percentage of participants achieving HbA1c<6.5% up to the 12-week endpoint.
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF).
Arm/Group Title 0.75 mg LY2189265 0.5 mg LY2189265 0.25 mg LY2189265 Placebo
Hide Arm/Group Description:
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Overall Number of Participants Analyzed 35 37 36 37
Measure Type: Number
Unit of Measure: percentage of participants
34.3 24.3 8.3 2.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, 0.5 mg LY2189265, 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This is the p-value from the Cochran-Armitage trend test.
Method Cochran-Armitage
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.358
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.5 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks
Hide Description Change in FBG following 12 weeks of therapy (that is, FBG at week 12 minus FBG at baseline). The change in FBG was analyzed using a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 dose of the study drug.
Arm/Group Title 0.75 mg LY2189265 0.5 mg LY2189265 0.25 mg LY2189265 Placebo
Hide Arm/Group Description:
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Overall Number of Participants Analyzed 35 37 36 37
Least Squares Mean (95% Confidence Interval)
Unit of Measure: milligrams per deciliter (mg/dL)
-37.48
(-47.00 to -27.97)
-28.55
(-37.68 to -19.41)
-29.21
(-38.45 to -19.97)
-9.00
(-18.39 to 0.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, 0.5 mg LY2189265, 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This is the p-value for the linear trend test at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -20.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.5 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Primary comparisons are based on the MMRM LS Mean Value at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -19.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Primary comparisons are based on the MMRM LS Mean Value at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -28.48
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks
Hide Description SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours postbreakfast, prior to lunch, 2 hours postlunch, prior to dinner, 2 hours postdinner, and prior to bed. The change in mean daily blood glucose was analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, and dose*visit, where the participant was treated as a random effect.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 dose of the study drug.
Arm/Group Title 0.75 mg LY2189265 0.5 mg LY2189265 0.25 mg LY2189265 Placebo
Hide Arm/Group Description:
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Overall Number of Participants Analyzed 29 35 33 30
Least Squares Mean (95% Confidence Interval)
Unit of Measure: milligrams per deciliter (mg/dL)
-48.99
(-58.47 to -39.51)
-53.12
(-61.84 to -44.41)
-40.70
(-49.67 to -31.73)
-7.49
(-17.44 to 2.45)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, 0.5 mg LY2189265, 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This is the p-value for the linear trend test at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -33.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.5 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Primary comparisons are based on the MMRM LS Mean Value at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -45.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Primary comparisons are based on the MMRM LS Mean Value at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -41.49
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Total Body Weight at 12 Weeks
Hide Description Changes in body weight were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 dose of the study drug.
Arm/Group Title 0.75 mg LY2189265 0.5 mg LY2189265 0.25 mg LY2189265 Placebo
Hide Arm/Group Description:
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Overall Number of Participants Analyzed 35 37 36 37
Least Squares Mean (95% Confidence Interval)
Unit of Measure: kilograms (kg)
-0.58
(-1.21 to 0.05)
-0.40
(-1.01 to 0.22)
0.41
(-0.20 to 1.03)
-0.84
(-1.46 to -0.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, 0.5 mg LY2189265, 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.987
Comments This is the p-value for the linear trend test at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.5 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.311
Comments Primary comparisons are based on the MMRM LS Mean Value at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.556
Comments Primary comparisons are based on the MMRM LS Mean Value at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.26
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks
Hide Description HOMA2-S is an estimated insulin sensitivity based on updated HOMA2 model. The HOMA2 model is a computer model that estimates insulin sensitivity (%S) as percentages of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-S were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 dose of the study drug.
Arm/Group Title 0.75 mg LY2189265 0.5 mg LY2189265 0.25 mg LY2189265 Placebo
Hide Arm/Group Description:
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Overall Number of Participants Analyzed 32 32 33 33
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage insulin sensitivity (%S)
-4.66
(-17.64 to 8.32)
-6.07
(-18.60 to 6.46)
4.65
(-7.68 to 16.97)
3.74
(-8.88 to 16.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, 0.5 mg LY2189265, 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.202
Comments This is the p-value from the linear trend test at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.917
Comments Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.5 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.264
Comments Primary comparisons are based on the MMRM LS Mean Value at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -9.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.346
Comments Primary comparisons are based on the MMRM LS Mean Value at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -8.40
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks
Hide Description HOMA2-B is an estimated steady state beta cell function based on updated HOMA2 model. The HOMA2 model estimates steady state pancreatic beta cell function (%B) as a percentage of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-B were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 dose of the study drug.
Arm/Group Title 0.75 mg LY2189265 0.5 mg LY2189265 0.25 mg LY2189265 Placebo
Hide Arm/Group Description:
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Overall Number of Participants Analyzed 32 32 33 33
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage beta-cell function
38.63
(29.36 to 47.90)
26.67
(17.74 to 35.61)
20.04
(11.19 to 28.89)
6.94
(-2.10 to 15.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, 0.5 mg LY2189265, 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This is the p-value for the linear trend test at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 13.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.5 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Primary comparisons are based on the MMRM LS Mean Value at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 19.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Primary comparisons are based on the MMRM LS Mean Value at week 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 31.68
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Steady-State Concentrations of LY2189265
Hide Description Evaluable pharmacokinetics (PK) concentrations from all sampling time-points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at 12 weeks. The model predicted LY2189265 steady state concentrations in each dose level were calculated as estimated area under the curve (AUC)/dosing period of 168 hours. The models and model parameters were described by nonlinear, mixed-effects regression modeling (NONMEM) using the program NONMEM 7®.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 dose of the study drug.
Arm/Group Title LY 0.25 mg LY 0.50 mg LY 0.75 mg
Hide Arm/Group Description:
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Overall Number of Participants Analyzed 36 36 34
Median (90% Confidence Interval)
Unit of Measure: nanograms per milliliter (ng/mL)
15.8
(10.4 to 27.0)
28.8
(19.2 to 47.4)
42.7
(24.3 to 70.0)
10.Secondary Outcome
Title Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period
Hide Description Assessed the percentage of participants who reported a hypoglycemic episode during the 12-week treatment period. Hypoglycemia was defined as a measured plasma glucose level of ≤70 milligrams per deciliter (mg/dL) or ≤3.9 millimoles per liter (mmol/L).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All randomized participants who received at least 1 dose of the study drug.
Arm/Group Title 0.75 mg LY2189265 0.5 mg LY2189265 0.25 mg LY2189265 Placebo
Hide Arm/Group Description:
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Administered by SC injection, QW for 12 weeks.
Overall Number of Participants Analyzed 35 37 36 37
Measure Type: Number
Unit of Measure: percentage of participants
5.7 2.7 0.0 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, 0.5 mg LY2189265, 0.25 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments This is the p-value from the Cochran-Armitage trend test (dose-effect).
Method Cochran-Armitage
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.5 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.75 mg LY2189265, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.233
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 0.25 mg LY2189265 0.5 mg LY2189265 0.75 mg LY2189265
Hide Arm/Group Description Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks. Administered by SC injection, QW for 12 weeks. Administered by SC injection, QW for 12 weeks. Administered by SC injection, QW for 12 weeks.
All-Cause Mortality
Placebo 0.25 mg LY2189265 0.5 mg LY2189265 0.75 mg LY2189265
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo 0.25 mg LY2189265 0.5 mg LY2189265 0.75 mg LY2189265
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/37 (0.00%)      1/36 (2.78%)      0/37 (0.00%)      1/35 (2.86%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Pancreatic carcinoma † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders         
VIIth nerve paralysis † 1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo 0.25 mg LY2189265 0.5 mg LY2189265 0.75 mg LY2189265
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/37 (43.24%)      17/36 (47.22%)      18/37 (48.65%)      15/35 (42.86%)    
Ear and labyrinth disorders         
Tinnitus † 1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Eye disorders         
Cataract † 1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Conjunctivitis allergic † 1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Gastrointestinal disorders         
Abdominal discomfort † 1  0/37 (0.00%)  0 1/36 (2.78%)  1 1/37 (2.70%)  2 1/35 (2.86%)  1
Abdominal distension † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Abdominal pain upper † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 2/37 (5.41%)  4 0/35 (0.00%)  0
Constipation † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/37 (0.00%)  0 3/35 (8.57%)  3
Dental caries † 1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Diarrhoea † 1  2/37 (5.41%)  2 1/36 (2.78%)  1 1/37 (2.70%)  1 1/35 (2.86%)  1
Flatulence † 1  0/37 (0.00%)  0 1/36 (2.78%)  2 0/37 (0.00%)  0 0/35 (0.00%)  0
Gastritis † 1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Gastritis erosive † 1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Gingivitis † 1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Nausea † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 6/37 (16.22%)  10 2/35 (5.71%)  3
Vomiting † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
General disorders         
Chest pain † 1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Fatigue † 1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/37 (0.00%)  0 1/35 (2.86%)  1
Pain † 1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Hepatobiliary disorders         
Hepatic steatosis † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Hyperplastic cholecystopathy † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Immune system disorders         
Seasonal allergy † 1  1/37 (2.70%)  1 2/36 (5.56%)  2 0/37 (0.00%)  0 2/35 (5.71%)  2
Infections and infestations         
Bronchitis † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Laryngitis † 1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Nasopharyngitis † 1  6/37 (16.22%)  8 3/36 (8.33%)  4 3/37 (8.11%)  5 3/35 (8.57%)  3
Rhinitis † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Upper respiratory tract infection † 1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Injury, poisoning and procedural complications         
Contusion † 1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Foot fracture † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Hand fracture † 1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Thermal burn † 1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Investigations         
Blood amylase increased † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Blood creatine phosphokinase increased † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Blood triglycerides increased † 1  0/37 (0.00%)  0 2/36 (5.56%)  2 0/37 (0.00%)  0 0/35 (0.00%)  0
Electrocardiogram abnormal † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain † 1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Intervertebral disc protrusion † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Musculoskeletal chest pain † 1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Periarthritis † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Spinal osteoarthritis † 1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adrenal adenoma † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders         
Headache † 1  1/37 (2.70%)  1 0/36 (0.00%)  0 3/37 (8.11%)  3 0/35 (0.00%)  0
Intercostal neuralgia † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Somnolence † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Psychiatric disorders         
Insomnia † 1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Rhinitis allergic † 1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Upper respiratory tract inflammation † 1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermatitis † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Dry skin † 1  1/37 (2.70%)  1 0/36 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Dyshidrosis † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Rash † 1  0/37 (0.00%)  0 1/36 (2.78%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Vascular disorders         
Hypertension † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Peripheral coldness † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Peripheral vascular disorder † 1  0/37 (0.00%)  0 0/36 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01001104    
Other Study ID Numbers: 12840
H9X-JE-GBCZ ( Other Identifier: Eli Lilly and Company )
First Submitted: October 22, 2009
First Posted: October 23, 2009
Results First Submitted: October 3, 2014
Results First Posted: September 28, 2015
Last Update Posted: September 28, 2015