Trial Outcomes & Findings for A Study for Patients With Type 1 Diabetes (NCT NCT01049412)
NCT ID: NCT01049412
Last Updated: 2018-04-17
Results Overview
It is the Avg. of the 8-point SMBG profiles, BG of morning fasting, midday \& evening pre-meal, 2-hour postprandial after each of the 3 main meals, bedtime, 0300 hours. Least squares (LS) mean of daily Avg. BG is from mixed-model repeated measures (MMRM), which includes fixed effects of treatment (LY2605541, Glargine); Treatment Sequence; treatment period; dose conversion (pre-interim analysis \[IA\], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline Hemoglobin \[HbA1c\] group); visit; visit and treatment interaction; a random effect for participant.
COMPLETED
PHASE2
138 participants
Week 8 of each treatment period
2018-04-17
Participant Flow
This is an open-label, randomized, 2-arm crossover study. The study consisted of two 8-week periods (Periods I and II) during which participants received Glargine for 8 weeks and LY2605541 for 8 weeks in a random sequence.
Participant milestones
| Measure |
LY2605541/Glargine
Participants took LY2605541 in Period I and Glargine in Period II
|
Glargine/LY2605541
Participants took Glargine in Period I and LY2605541 in Period II
|
|---|---|---|
|
Period I
STARTED
|
70
|
68
|
|
Period I
Took at Least One Dose of Study Drug
|
69
|
68
|
|
Period I
COMPLETED
|
62
|
55
|
|
Period I
NOT COMPLETED
|
8
|
13
|
|
Period II
STARTED
|
62
|
55
|
|
Period II
COMPLETED
|
58
|
52
|
|
Period II
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
LY2605541/Glargine
Participants took LY2605541 in Period I and Glargine in Period II
|
Glargine/LY2605541
Participants took Glargine in Period I and LY2605541 in Period II
|
|---|---|---|
|
Period I
Withdrawal by Subject
|
4
|
6
|
|
Period I
Lost to Follow-up
|
2
|
2
|
|
Period I
Physician Decision
|
0
|
3
|
|
Period I
Protocol Violation
|
1
|
2
|
|
Period I
Adverse Event
|
1
|
0
|
|
Period II
Withdrawal by Subject
|
2
|
3
|
|
Period II
Adverse Event
|
1
|
0
|
|
Period II
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Study for Patients With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
LY2605541/Glargine
n=69 Participants
Participants took LY2605541 in Period I and Glargine in Period II
|
Glargine/LY2605541
n=68 Participants
Participants took Glargine in Period I and LY2605541 in Period II
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.82 years
STANDARD_DEVIATION 11.34 • n=5 Participants
|
39.53 years
STANDARD_DEVIATION 12.28 • n=7 Participants
|
38.17 years
STANDARD_DEVIATION 11.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
65 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8 of each treatment periodPopulation: All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.
It is the Avg. of the 8-point SMBG profiles, BG of morning fasting, midday \& evening pre-meal, 2-hour postprandial after each of the 3 main meals, bedtime, 0300 hours. Least squares (LS) mean of daily Avg. BG is from mixed-model repeated measures (MMRM), which includes fixed effects of treatment (LY2605541, Glargine); Treatment Sequence; treatment period; dose conversion (pre-interim analysis \[IA\], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline Hemoglobin \[HbA1c\] group); visit; visit and treatment interaction; a random effect for participant.
Outcome measures
| Measure |
LY2605541
n=92 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
Glargine
n=91 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
|---|---|---|
|
Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles
|
7.98 millimole per Liter (mmol/L)
Standard Error 0.32
|
8.53 millimole per Liter (mmol/L)
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Baseline, Week 8 of each treatment periodPopulation: All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.
It is the Avg. of the 8-point SMBG profiles, BG of morning fasting, midday \& evening pre-meal, 2-hour postprandial after each of the 3 main meals, bedtime, 0300 hours. LS mean of daily Avg. BG is from MMRM, which includes fixed effects of treatment (LY2605541, Glargine); Treatment Sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; a random effect for participant.
Outcome measures
| Measure |
LY2605541
n=92 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
Glargine
n=91 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
|---|---|---|
|
Change From Baseline in Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles
|
-0.74 mmol/L
Standard Error 0.40
|
-0.18 mmol/L
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Baseline, Week 8 (Period I)Population: All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean of the change from baseline to 8-week at Period I is from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group); baseline HbA1c; visit; interaction between visit and treatment; and a random effect for participant.
Outcome measures
| Measure |
LY2605541
n=62 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
Glargine
n=54 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
|---|---|---|
|
Change From Baseline in Hemoglobin (HbA1c) at Week 8 Endpoint of Period I
|
-0.45 percentage of glycated hemoglobin
Standard Error 0.10
|
-0.34 percentage of glycated hemoglobin
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Week 8 (Period I)Population: All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value, last observation carried forward (LOCF).
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
LY2605541
n=65 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
Glargine
n=60 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
|---|---|---|
|
Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint of Period I
HbA1c ≤6.5%
|
24.6 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint of Period I
HbA1c <7.0%
|
43.1 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8 (Period I)Population: All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value, last observation carried forward (LOCF).
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 millimole/Liter (mmol/L) (≤70 milligram/deciliter \[mg/dL\]) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines \[ADA 2005\]).
Outcome measures
| Measure |
LY2605541
n=65 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
Glargine
n=60 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
|---|---|---|
|
Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment (Period I)
HbA1c <7.0%
|
1.5 percentage of participants
|
1.7 percentage of participants
|
|
Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment (Period I)
HbA1c ≤6.5%
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8 of each treatment periodPopulation: All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.
8-point SMBG profiles are measured at morning fasting BG (FBG), midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean is obtained from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); treatment sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant.
Outcome measures
| Measure |
LY2605541
n=124 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
Glargine
n=130 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
|---|---|---|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint
0300 hours BG
|
8.97 mmol/L
Standard Error 0.50
|
8.67 mmol/L
Standard Error 0.51
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint
Morning FBG
|
9.33 mmol/L
Standard Error 0.45
|
9.57 mmol/L
Standard Error 0.49
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint
Morning 2-hr postprandial BG
|
8.27 mmol/L
Standard Error 0.46
|
8.76 mmol/L
Standard Error 0.46
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint
Midday Pre-meal BG
|
6.98 mmol/L
Standard Error 0.43
|
7.52 mmol/L
Standard Error 0.45
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint
Midday 2-hr postprandial BG
|
8.08 mmol/L
Standard Error 0.44
|
8.60 mmol/L
Standard Error 0.47
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint
Evening Pre-meal BG
|
7.87 mmol/L
Standard Error 0.38
|
8.73 mmol/L
Standard Error 0.41
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint
Evening 2-hr postprandial BG
|
8.37 mmol/L
Standard Error 0.44
|
9.26 mmol/L
Standard Error 0.46
|
|
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint
Bed time BG
|
8.20 mmol/L
Standard Error 0.45
|
9.29 mmol/L
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Week 2 and Week 8 of each treatment periodPopulation: All randomized participants who took at least one dose of study drug with at least one non-missing value of the response variable at any of the subsequent weeks.
LS mean is obtained from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); treatment sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant.
Outcome measures
| Measure |
LY2605541
n=124 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
Glargine
n=130 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
|---|---|---|
|
Daily Basal Insulin Dose at Week 2 and Week 8 Endpoint
Week 8
|
4.12 nanomoles per kilogram (nmoles/kg)
Standard Deviation 0.18
|
2.86 nanomoles per kilogram (nmoles/kg)
Standard Deviation 0.16
|
|
Daily Basal Insulin Dose at Week 2 and Week 8 Endpoint
Week 2
|
3.35 nanomoles per kilogram (nmoles/kg)
Standard Deviation 0.16
|
2.58 nanomoles per kilogram (nmoles/kg)
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Week 8 of each treatment periodPopulation: Participants who took at least one dose of study drug and had measurements at Week 8.
The drug (LY2605541) concentration at steady state (Css) is calculated from the clearance (Liter/hour) and the final dose of the participants. Clearance was estimated using population-based approaches.
Outcome measures
| Measure |
LY2605541
n=115 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
Glargine
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
|---|---|---|
|
Pharmacokinetics - Drug (LY2605541) Concentration at Steady State (Css) at Week 8 Endpoint
|
2873 picomoles per liter (pMol/L)
Geometric Coefficient of Variation 54.9
|
—
|
SECONDARY outcome
Timeframe: Week 8, Week 16 and Week 20Population: All randomized participants who took at least one dose of study drug with both baseline and endpoint antibody measurements.
Negative is defined as either 'negative' from lab or percent binding \<1.16%. Positive is defined as the percent binding is ≥1.16%. The antibody status change is from negative to positive or positive to negative.
Outcome measures
| Measure |
LY2605541
n=69 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
Glargine
n=68 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
|---|---|---|
|
Percentage of Participants With Antibody Status Change From Baseline to Week 8, Week 16 and Week 20
Week 8 (Period I) from negative to positive
|
8.3 percentage of participants
|
3.3 percentage of participants
|
|
Percentage of Participants With Antibody Status Change From Baseline to Week 8, Week 16 and Week 20
Week 8 (Period I) from positive to negative
|
3.3 percentage of participants
|
5.0 percentage of participants
|
|
Percentage of Participants With Antibody Status Change From Baseline to Week 8, Week 16 and Week 20
Week 16 (Period II) from negative to positive
|
12.5 percentage of participants
|
7.4 percentage of participants
|
|
Percentage of Participants With Antibody Status Change From Baseline to Week 8, Week 16 and Week 20
Week 16 (Period II) from positive to negative
|
1.8 percentage of participants
|
7.4 percentage of participants
|
|
Percentage of Participants With Antibody Status Change From Baseline to Week 8, Week 16 and Week 20
Week 20 (follow up) from negative to positive
|
14.8 percentage of participants
|
11.5 percentage of participants
|
|
Percentage of Participants With Antibody Status Change From Baseline to Week 8, Week 16 and Week 20
Week 20 (follow up) from positive to negative
|
1.9 percentage of participants
|
3.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Week 8 of each treatment periodPopulation: All randomized participants who took at least one dose of study drug.
Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 millimole per Liter (mmol/L) (≤70 milligram per deciliter \[mg/dL\]) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines \[ADA 2005\].
Outcome measures
| Measure |
LY2605541
n=124 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
Glargine
n=130 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
|---|---|---|
|
Percentage of Participants With Hypoglycemia Baseline Through Week 8
|
92.7 percentage of participants
|
90.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Week 8 of each treatment periodPopulation: All randomized participants who took at least one dose of study drug.
Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines \[ADA 2005\]. Hypoglycemia rate per 30 days is calculated as the number of hypoglycemia/number of days at risk\*30.
Outcome measures
| Measure |
LY2605541
n=124 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
Glargine
n=130 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
|---|---|---|
|
Rate of Hypoglycemia Per 30 Days Baseline Through Week 8
|
8.74 number of hypoglycemia episodes/30 days
Standard Deviation 7.70
|
7.36 number of hypoglycemia episodes/30 days
Standard Deviation 6.80
|
SECONDARY outcome
Timeframe: Week 8 of each treatment periodPopulation: All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.
Within-patient glycemic variability was assessed as the standard deviation of fasting blood glucose each day between Week 6 and Week 8. LS mean is obtained from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); treatment sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant.
Outcome measures
| Measure |
LY2605541
n=107 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
Glargine
n=107 Participants
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
|
|---|---|---|
|
Glycemic Variability in Fasting Blood Glucose (FBG) at Week 8 Endpoint
|
3.13 mmol/L
Standard Error 0.23
|
3.60 mmol/L
Standard Error 0.24
|
Adverse Events
LY2605541
Glargine
Serious adverse events
| Measure |
LY2605541
n=125 participants at risk
Participants took LY2605541 administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks
|
Glargine
n=130 participants at risk
Participants took Glargine administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks
|
|---|---|---|
|
Infections and infestations
Urosepsis
|
0.00%
0/125
|
0.77%
1/130 • Number of events 1
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.80%
1/125 • Number of events 1
|
0.00%
0/130
|
|
Injury, poisoning and procedural complications
Fall
|
0.80%
1/125 • Number of events 1
|
0.00%
0/130
|
|
Metabolism and nutrition disorders
Severe hypoglycaemia
|
4.0%
5/125 • Number of events 6
|
2.3%
3/130 • Number of events 6
|
Other adverse events
| Measure |
LY2605541
n=125 participants at risk
Participants took LY2605541 administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks
|
Glargine
n=130 participants at risk
Participants took Glargine administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
2/125 • Number of events 2
|
1.5%
2/130 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.6%
2/125 • Number of events 2
|
0.77%
1/130 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
3.2%
4/125 • Number of events 5
|
0.00%
0/130
|
|
Gastrointestinal disorders
Dyspepsia
|
3.2%
4/125 • Number of events 4
|
0.77%
1/130 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.2%
4/125 • Number of events 4
|
0.77%
1/130 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
1.6%
2/125 • Number of events 2
|
0.77%
1/130 • Number of events 1
|
|
General disorders
Chest pain
|
1.6%
2/125 • Number of events 2
|
0.00%
0/130
|
|
General disorders
Fatigue
|
1.6%
2/125 • Number of events 2
|
0.00%
0/130
|
|
General disorders
Pyrexia
|
0.80%
1/125 • Number of events 1
|
2.3%
3/130 • Number of events 3
|
|
Infections and infestations
Influenza
|
0.80%
1/125 • Number of events 1
|
1.5%
2/130 • Number of events 2
|
|
Infections and infestations
Localised infection
|
1.6%
2/125 • Number of events 2
|
0.00%
0/130
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
4/125 • Number of events 4
|
2.3%
3/130 • Number of events 3
|
|
Infections and infestations
Onychomycosis
|
1.6%
2/125 • Number of events 2
|
1.5%
2/130 • Number of events 2
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.6%
2/125 • Number of events 2
|
1.5%
2/130 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
0.00%
0/125
|
3.1%
4/130 • Number of events 4
|
|
Infections and infestations
Upper respiratory tract infection
|
6.4%
8/125 • Number of events 8
|
5.4%
7/130 • Number of events 7
|
|
Infections and infestations
Urinary tract infection
|
0.80%
1/125 • Number of events 1
|
2.3%
3/130 • Number of events 4
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.6%
2/125 • Number of events 2
|
1.5%
2/130 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.4%
3/125 • Number of events 3
|
3.1%
4/130 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
3/125 • Number of events 3
|
0.77%
1/130 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
2/125 • Number of events 2
|
1.5%
2/130 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.80%
1/125 • Number of events 1
|
1.5%
2/130 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.6%
2/125 • Number of events 2
|
1.5%
2/130 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/125
|
1.5%
2/130 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
5/125 • Number of events 5
|
2.3%
3/130 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
0.00%
0/125
|
1.5%
2/130 • Number of events 2
|
|
Nervous system disorders
Headache
|
4.8%
6/125 • Number of events 7
|
5.4%
7/130 • Number of events 7
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.6%
2/125 • Number of events 2
|
0.77%
1/130 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.80%
1/125 • Number of events 1
|
1.5%
2/130 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.6%
2/125 • Number of events 2
|
2.3%
3/130 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/125
|
1.5%
2/130 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
2/125 • Number of events 2
|
0.77%
1/130 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
2/125 • Number of events 2
|
0.00%
0/130
|
|
Vascular disorders
Hypertension
|
2.4%
3/125 • Number of events 3
|
1.5%
2/130 • Number of events 2
|
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