Trial Outcomes & Findings for A Study of LY2189265 in Japanese Patients With Type 2 Diabetes (NCT NCT01001104)
NCT ID: NCT01001104
Last Updated: 2015-09-28
Results Overview
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.
COMPLETED
PHASE2
145 participants
Baseline, 12 weeks
2015-09-28
Participant Flow
Participant milestones
| Measure |
0.75 mg LY2189265
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
|
0.5 mg LY2189265
Administered by SC injection, QW for 12 weeks.
|
0.25 mg LY2189265
Administered by SC injection, QW for 12 weeks.
|
Placebo
Administered by SC injection, QW for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
37
|
36
|
37
|
|
Overall Study
COMPLETED
|
33
|
36
|
35
|
34
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
0.75 mg LY2189265
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
|
0.5 mg LY2189265
Administered by SC injection, QW for 12 weeks.
|
0.25 mg LY2189265
Administered by SC injection, QW for 12 weeks.
|
Placebo
Administered by SC injection, QW for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Entry Criteria Not Met
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Study of LY2189265 in Japanese Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
0.75 mg LY2189265
n=35 Participants
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
|
0.5 mg LY2189265
n=37 Participants
Administered by SC injection, QW for 12 weeks.
|
0.25 mg LY2189265
n=36 Participants
Administered by SC injection, QW for 12 weeks.
|
Placebo
n=37 Participants
Administered by SC injection, QW for 12 weeks.
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.23 years
STANDARD_DEVIATION 7.80 • n=5 Participants
|
52.50 years
STANDARD_DEVIATION 9.17 • n=7 Participants
|
52.26 years
STANDARD_DEVIATION 8.82 • n=5 Participants
|
51.70 years
STANDARD_DEVIATION 9.67 • n=4 Participants
|
52.17 years
STANDARD_DEVIATION 8.82 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
35 participants
n=5 Participants
|
37 participants
n=7 Participants
|
36 participants
n=5 Participants
|
37 participants
n=4 Participants
|
145 participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
35 participants
n=5 Participants
|
37 participants
n=7 Participants
|
36 participants
n=5 Participants
|
37 participants
n=4 Participants
|
145 participants
n=21 Participants
|
|
Percentage of Glycosylated Hemoglobin (HbA1c)
|
8.01 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.63 • n=5 Participants
|
7.98 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.66 • n=7 Participants
|
8.05 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.66 • n=5 Participants
|
7.98 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.64 • n=4 Participants
|
8.00 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.64 • n=21 Participants
|
|
Fasting Blood Glucose (FBG)
|
156.51 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 26.43 • n=5 Participants
|
150.95 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 29.31 • n=7 Participants
|
158.75 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 35.62 • n=5 Participants
|
159.65 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 33.29 • n=4 Participants
|
156.45 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 31.26 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
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.
Outcome measures
| Measure |
0.75 mg LY2189265
n=34 Participants
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
|
0.5 mg LY2189265
n=37 Participants
Administered by SC injection, QW for 12 weeks.
|
0.25 mg LY2189265
n=36 Participants
Administered by SC injection, QW for 12 weeks.
|
Placebo
n=36 Participants
Administered by SC injection, QW for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks
|
-1.35 percentage glycosylated hemoglobin
Interval -1.53 to -1.18
|
-1.15 percentage glycosylated hemoglobin
Interval -1.32 to -0.98
|
-0.90 percentage glycosylated hemoglobin
Interval -1.07 to -0.73
|
-0.18 percentage glycosylated hemoglobin
Interval -0.36 to -0.01
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF).
Percentage of participants who achieved HbA1c\<7% up to the 12-week endpoint.
Outcome measures
| Measure |
0.75 mg LY2189265
n=35 Participants
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
|
0.5 mg LY2189265
n=37 Participants
Administered by SC injection, QW for 12 weeks.
|
0.25 mg LY2189265
n=36 Participants
Administered by SC injection, QW for 12 weeks.
|
Placebo
n=37 Participants
Administered by SC injection, QW for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks
|
77.1 percentage of participants
|
59.5 percentage of participants
|
47.2 percentage of participants
|
10.8 percentage of participants
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF).
Percentage of participants achieving HbA1c\<6.5% up to the 12-week endpoint.
Outcome measures
| Measure |
0.75 mg LY2189265
n=35 Participants
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
|
0.5 mg LY2189265
n=37 Participants
Administered by SC injection, QW for 12 weeks.
|
0.25 mg LY2189265
n=36 Participants
Administered by SC injection, QW for 12 weeks.
|
Placebo
n=37 Participants
Administered by SC injection, QW for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks
|
34.3 percentage of participants
|
24.3 percentage of participants
|
8.3 percentage of participants
|
2.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
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.
Outcome measures
| Measure |
0.75 mg LY2189265
n=35 Participants
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
|
0.5 mg LY2189265
n=37 Participants
Administered by SC injection, QW for 12 weeks.
|
0.25 mg LY2189265
n=36 Participants
Administered by SC injection, QW for 12 weeks.
|
Placebo
n=37 Participants
Administered by SC injection, QW for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks
|
-37.48 milligrams per deciliter (mg/dL)
Interval -47.0 to -27.97
|
-28.55 milligrams per deciliter (mg/dL)
Interval -37.68 to -19.41
|
-29.21 milligrams per deciliter (mg/dL)
Interval -38.45 to -19.97
|
-9.00 milligrams per deciliter (mg/dL)
Interval -18.39 to 0.38
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
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.
Outcome measures
| Measure |
0.75 mg LY2189265
n=29 Participants
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
|
0.5 mg LY2189265
n=35 Participants
Administered by SC injection, QW for 12 weeks.
|
0.25 mg LY2189265
n=33 Participants
Administered by SC injection, QW for 12 weeks.
|
Placebo
n=30 Participants
Administered by SC injection, QW for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks
|
-48.99 milligrams per deciliter (mg/dL)
Interval -58.47 to -39.51
|
-53.12 milligrams per deciliter (mg/dL)
Interval -61.84 to -44.41
|
-40.70 milligrams per deciliter (mg/dL)
Interval -49.67 to -31.73
|
-7.49 milligrams per deciliter (mg/dL)
Interval -17.44 to 2.45
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
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.
Outcome measures
| Measure |
0.75 mg LY2189265
n=35 Participants
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
|
0.5 mg LY2189265
n=37 Participants
Administered by SC injection, QW for 12 weeks.
|
0.25 mg LY2189265
n=36 Participants
Administered by SC injection, QW for 12 weeks.
|
Placebo
n=37 Participants
Administered by SC injection, QW for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Total Body Weight at 12 Weeks
|
-0.58 kilograms (kg)
Interval -1.21 to 0.05
|
-0.40 kilograms (kg)
Interval -1.01 to 0.22
|
0.41 kilograms (kg)
Interval -0.2 to 1.03
|
-0.84 kilograms (kg)
Interval -1.46 to -0.22
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
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.
Outcome measures
| Measure |
0.75 mg LY2189265
n=32 Participants
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
|
0.5 mg LY2189265
n=32 Participants
Administered by SC injection, QW for 12 weeks.
|
0.25 mg LY2189265
n=33 Participants
Administered by SC injection, QW for 12 weeks.
|
Placebo
n=33 Participants
Administered by SC injection, QW for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks
|
-4.66 percentage insulin sensitivity (%S)
Interval -17.64 to 8.32
|
-6.07 percentage insulin sensitivity (%S)
Interval -18.6 to 6.46
|
4.65 percentage insulin sensitivity (%S)
Interval -7.68 to 16.97
|
3.74 percentage insulin sensitivity (%S)
Interval -8.88 to 16.36
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
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.
Outcome measures
| Measure |
0.75 mg LY2189265
n=32 Participants
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
|
0.5 mg LY2189265
n=32 Participants
Administered by SC injection, QW for 12 weeks.
|
0.25 mg LY2189265
n=33 Participants
Administered by SC injection, QW for 12 weeks.
|
Placebo
n=33 Participants
Administered by SC injection, QW for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks
|
38.63 percentage beta-cell function
Interval 29.36 to 47.9
|
26.67 percentage beta-cell function
Interval 17.74 to 35.61
|
20.04 percentage beta-cell function
Interval 11.19 to 28.89
|
6.94 percentage beta-cell function
Interval -2.1 to 15.98
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
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®.
Outcome measures
| Measure |
0.75 mg LY2189265
n=36 Participants
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
|
0.5 mg LY2189265
n=36 Participants
Administered by SC injection, QW for 12 weeks.
|
0.25 mg LY2189265
n=34 Participants
Administered by SC injection, QW for 12 weeks.
|
Placebo
Administered by SC injection, QW for 12 weeks.
|
|---|---|---|---|---|
|
Steady-State Concentrations of LY2189265
|
15.8 nanograms per milliliter (ng/mL)
Interval 10.4 to 27.0
|
28.8 nanograms per milliliter (ng/mL)
Interval 19.2 to 47.4
|
42.7 nanograms per milliliter (ng/mL)
Interval 24.3 to 70.0
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
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).
Outcome measures
| Measure |
0.75 mg LY2189265
n=35 Participants
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
|
0.5 mg LY2189265
n=37 Participants
Administered by SC injection, QW for 12 weeks.
|
0.25 mg LY2189265
n=36 Participants
Administered by SC injection, QW for 12 weeks.
|
Placebo
n=37 Participants
Administered by SC injection, QW for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period
|
5.7 percentage of participants
|
2.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Placebo
0.25 mg LY2189265
0.5 mg LY2189265
0.75 mg LY2189265
Serious adverse events
| Measure |
Placebo
n=37 participants at risk
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
|
0.25 mg LY2189265
n=36 participants at risk
Administered by SC injection, QW for 12 weeks.
|
0.5 mg LY2189265
n=37 participants at risk
Administered by SC injection, QW for 12 weeks.
|
0.75 mg LY2189265
n=35 participants at risk
Administered by SC injection, QW for 12 weeks.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/37
|
0.00%
0/36
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/37
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
Other adverse events
| Measure |
Placebo
n=37 participants at risk
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
|
0.25 mg LY2189265
n=36 participants at risk
Administered by SC injection, QW for 12 weeks.
|
0.5 mg LY2189265
n=37 participants at risk
Administered by SC injection, QW for 12 weeks.
|
0.75 mg LY2189265
n=35 participants at risk
Administered by SC injection, QW for 12 weeks.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/37
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Eye disorders
Cataract
|
0.00%
0/37
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Eye disorders
Conjunctivitis allergic
|
2.7%
1/37 • Number of events 1
|
0.00%
0/36
|
0.00%
0/37
|
0.00%
0/35
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/37
|
2.8%
1/36 • Number of events 1
|
2.7%
1/37 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/37
|
0.00%
0/36
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/37
|
0.00%
0/36
|
5.4%
2/37 • Number of events 4
|
0.00%
0/35
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/37
|
0.00%
0/36
|
0.00%
0/37
|
8.6%
3/35 • Number of events 3
|
|
Gastrointestinal disorders
Dental caries
|
2.7%
1/37 • Number of events 1
|
0.00%
0/36
|
0.00%
0/37
|
0.00%
0/35
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
2/37 • Number of events 2
|
2.8%
1/36 • Number of events 1
|
2.7%
1/37 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/37
|
2.8%
1/36 • Number of events 2
|
0.00%
0/37
|
0.00%
0/35
|
|
Gastrointestinal disorders
Gastritis
|
2.7%
1/37 • Number of events 1
|
0.00%
0/36
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/37
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/37
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/37
|
0.00%
0/36
|
16.2%
6/37 • Number of events 10
|
5.7%
2/35 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/37
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
General disorders
Chest pain
|
2.7%
1/37 • Number of events 1
|
0.00%
0/36
|
0.00%
0/37
|
0.00%
0/35
|
|
General disorders
Fatigue
|
0.00%
0/37
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/37
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/37
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Hepatobiliary disorders
Hyperplastic cholecystopathy
|
0.00%
0/37
|
0.00%
0/36
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
2.7%
1/37 • Number of events 1
|
5.6%
2/36 • Number of events 2
|
0.00%
0/37
|
5.7%
2/35 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
0.00%
0/37
|
0.00%
0/36
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Laryngitis
|
0.00%
0/37
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Infections and infestations
Nasopharyngitis
|
16.2%
6/37 • Number of events 8
|
8.3%
3/36 • Number of events 4
|
8.1%
3/37 • Number of events 5
|
8.6%
3/35 • Number of events 3
|
|
Infections and infestations
Rhinitis
|
0.00%
0/37
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
1/37 • Number of events 1
|
0.00%
0/36
|
0.00%
0/37
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/37
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/37
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/37
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/37
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Investigations
Blood amylase increased
|
0.00%
0/37
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/37
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/37
|
5.6%
2/36 • Number of events 2
|
0.00%
0/37
|
0.00%
0/35
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/37
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/37
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
1/37 • Number of events 1
|
0.00%
0/36
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/37
|
0.00%
0/36
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/37
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/37
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.7%
1/37 • Number of events 1
|
0.00%
0/36
|
0.00%
0/37
|
0.00%
0/35
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/37
|
0.00%
0/36
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Nervous system disorders
Headache
|
2.7%
1/37 • Number of events 1
|
0.00%
0/36
|
8.1%
3/37 • Number of events 3
|
0.00%
0/35
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/37
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Nervous system disorders
Somnolence
|
0.00%
0/37
|
0.00%
0/36
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
2.7%
1/37 • Number of events 1
|
0.00%
0/36
|
0.00%
0/37
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.7%
1/37 • Number of events 1
|
0.00%
0/36
|
0.00%
0/37
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
2.7%
1/37 • Number of events 1
|
0.00%
0/36
|
0.00%
0/37
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/37
|
0.00%
0/36
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.7%
1/37 • Number of events 1
|
0.00%
0/36
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
0.00%
0/37
|
0.00%
0/36
|
2.7%
1/37 • Number of events 1
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/37
|
2.8%
1/36 • Number of events 1
|
0.00%
0/37
|
0.00%
0/35
|
|
Vascular disorders
Hypertension
|
0.00%
0/37
|
0.00%
0/36
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/37
|
0.00%
0/36
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/37
|
0.00%
0/36
|
0.00%
0/37
|
2.9%
1/35 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60