Trial Outcomes & Findings for Comparison of Insulin Mix25 Versus Mix50 (NCT NCT01773473)
NCT ID: NCT01773473
Last Updated: 2015-05-21
Results Overview
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by Mixed Models Repeated Measurements (MMRM) analysis using change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, blood glucose (BG) excursion, country, visit and treatment-by-visit interaction as fixed effects, baseline HbA1c value as a covariate and participants as a random effect.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
403 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2015-05-21
Participant Flow
This study consisted of a 26-week treatment period (12-week, weekly-intensive, dose-adjustment period and 14-week maintenance period).
Participant milestones
| Measure |
Insulin Lispro Mix25
Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.
|
Insulin Lispro Mix50
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
207
|
196
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
207
|
196
|
|
Overall Study
COMPLETED
|
191
|
177
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
Reasons for withdrawal
| Measure |
Insulin Lispro Mix25
Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.
|
Insulin Lispro Mix50
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Protocol Violation
|
0
|
4
|
|
Overall Study
Physician Decision
|
3
|
5
|
|
Overall Study
Sponsor Decision
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Non-Compliance with study drug
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Comparison of Insulin Mix25 Versus Mix50
Baseline characteristics by cohort
| Measure |
Insulin Lispro Mix25
n=207 Participants
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
|
Insulin Lispro Mix50
n=196 Participants
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.74 years
STANDARD_DEVIATION 10.026 • n=93 Participants
|
57.34 years
STANDARD_DEVIATION 9.664 • n=4 Participants
|
56.52 years
STANDARD_DEVIATION 9.871 • n=27 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
153 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=93 Participants
|
119 Participants
n=4 Participants
|
250 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
192 Participants
n=93 Participants
|
182 Participants
n=4 Participants
|
374 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Turkey
|
15 participants
n=93 Participants
|
14 participants
n=4 Participants
|
29 participants
n=27 Participants
|
|
Region of Enrollment
Japan
|
88 participants
n=93 Participants
|
84 participants
n=4 Participants
|
172 participants
n=27 Participants
|
|
Region of Enrollment
China
|
80 participants
n=93 Participants
|
76 participants
n=4 Participants
|
156 participants
n=27 Participants
|
|
Region of Enrollment
Korea, Republic of
|
24 participants
n=93 Participants
|
22 participants
n=4 Participants
|
46 participants
n=27 Participants
|
|
Duration of Type-2 Diabetes Mellitus (T2DM)
|
9.74 years
STANDARD_DEVIATION 6.169 • n=93 Participants
|
9.15 years
STANDARD_DEVIATION 6.336 • n=4 Participants
|
9.45 years
STANDARD_DEVIATION 6.250 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 HbA1c measurements.
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by Mixed Models Repeated Measurements (MMRM) analysis using change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, blood glucose (BG) excursion, country, visit and treatment-by-visit interaction as fixed effects, baseline HbA1c value as a covariate and participants as a random effect.
Outcome measures
| Measure |
Insulin Lispro Mix25
n=192 Participants
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
|
Insulin Lispro Mix50
n=179 Participants
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
|
-1.52 percentage of glycosylated hemoglobin
Interval -1.66 to -1.39
|
-1.69 percentage of glycosylated hemoglobin
Interval -1.83 to -1.55
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and at least 1 post-baseline HbA1c measurement.
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. The percentage of participants with HbA1c \<7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (\<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.
Outcome measures
| Measure |
Insulin Lispro Mix25
n=207 Participants
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
|
Insulin Lispro Mix50
n=196 Participants
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26
<7.0%
|
45.9 percentage of participants
|
59.7 percentage of participants
|
|
Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26
≤6.5%
|
26.1 percentage of participants
|
42.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 FBG measurement.
LS means were calculated by MMRM analysis using change from baseline in FBG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline self-monitoring blood glucose (SMBG) variable value as a covariate and participants as a random effect.
Outcome measures
| Measure |
Insulin Lispro Mix25
n=207 Participants
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
|
Insulin Lispro Mix50
n=196 Participants
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (FBG) at Week 26
|
-2.37 millimoles per liter (mmol/L)
Interval -2.68 to -2.06
|
-1.99 millimoles per liter (mmol/L)
Interval -2.3 to -1.68
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least 1 dose of study drug and had baseline and Week 26 body weight measurements.
LS means were calculated by MMRM analysis using change from baseline in weight variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect.
Outcome measures
| Measure |
Insulin Lispro Mix25
n=207 Participants
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
|
Insulin Lispro Mix50
n=196 Participants
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 26
|
2.31 kilogram (kg)
Interval 1.85 to 2.77
|
2.32 kilogram (kg)
Interval 1.84 to 2.79
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: All randomized participants who received at least 1 dose of study drug.
A hypoglycemic event 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 concentration of ≤ 70milligrams/deciliter \[mg/dL (3.9 mmol/L)\], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines \[American Diabetes Association (ADA) 2005\].
Outcome measures
| Measure |
Insulin Lispro Mix25
n=207 Participants
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
|
Insulin Lispro Mix50
n=196 Participants
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
|
|---|---|---|
|
Number of Hypoglycemic Events Baseline Through Week 26 (Incidence)
All Hypoglycemic Events
|
568 events
|
583 events
|
|
Number of Hypoglycemic Events Baseline Through Week 26 (Incidence)
Severe Hypoglycemic Events
|
0 events
|
1 events
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had Week 26 insulin dose measurement.
Insulin dose is the total daily dose including basal and prandial doses.
Outcome measures
| Measure |
Insulin Lispro Mix25
n=207 Participants
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
|
Insulin Lispro Mix50
n=196 Participants
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
|
|---|---|---|
|
Insulin Dose at Week 26
|
40.02 units of insulin per day (IU/day)
Standard Deviation 17.771
|
39.32 units of insulin per day (IU/day)
Standard Deviation 17.991
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 1,5-AG measurements.
LS means were calculated by MMRM analysis using change from baseline in 1.5-AG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect.
Outcome measures
| Measure |
Insulin Lispro Mix25
n=207 Participants
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
|
Insulin Lispro Mix50
n=196 Participants
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
|
|---|---|---|
|
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
|
4.24 micrograms/milliliter (µg/mL)
Interval 3.39 to 5.1
|
5.62 micrograms/milliliter (µg/mL)
Interval 4.74 to 6.51
|
Adverse Events
Insulin Lispro Mix25
Serious events: 8 serious events
Other events: 87 other events
Deaths: 0 deaths
Insulin Lispro Mix50
Serious events: 7 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Lispro Mix25
n=207 participants at risk
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
|
Insulin Lispro Mix50
n=196 participants at risk
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Nervous system disorders
Brain stem infarction
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Nervous system disorders
Cerebellar infarction
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
Other adverse events
| Measure |
Insulin Lispro Mix25
n=207 participants at risk
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
|
Insulin Lispro Mix50
n=196 participants at risk
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Ear and labyrinth disorders
Tinnitus
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Ear and labyrinth disorders
Vertigo
|
0.97%
2/207 • Number of events 2
|
0.00%
0/196
|
|
Eye disorders
Arteriosclerotic retinopathy
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Eye disorders
Cataract
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Eye disorders
Dry eye
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Eye disorders
Glaucoma
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Eye disorders
Keratitis
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Eye disorders
Ocular hyperaemia
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Eye disorders
Punctate keratitis
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.48%
1/207 • Number of events 1
|
1.0%
2/196 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/207
|
0.51%
1/196 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.97%
2/207 • Number of events 2
|
1.5%
3/196 • Number of events 6
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/207
|
2.0%
4/196 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
0.48%
1/207 • Number of events 1
|
3.6%
7/196 • Number of events 8
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/207
|
1.5%
3/196 • Number of events 3
|
|
Gastrointestinal disorders
Faecaloma
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Gastrointestinal disorders
Gastritis
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Gastrointestinal disorders
Gingival pain
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.48%
1/207 • Number of events 1
|
1.0%
2/196 • Number of events 2
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.97%
2/207 • Number of events 2
|
1.0%
2/196 • Number of events 3
|
|
Gastrointestinal disorders
Oesophageal discomfort
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
General disorders
Chest pain
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
General disorders
Feeling abnormal
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
General disorders
Injection site bruising
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
General disorders
Injection site erythema
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
General disorders
Injection site haemorrhage
|
0.48%
1/207 • Number of events 2
|
0.00%
0/196
|
|
General disorders
Injection site induration
|
0.97%
2/207 • Number of events 2
|
0.00%
0/196
|
|
General disorders
Injection site pain
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
General disorders
Injection site pruritus
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
General disorders
Injection site reaction
|
0.00%
0/207
|
1.0%
2/196 • Number of events 2
|
|
General disorders
Local swelling
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Immune system disorders
Drug hypersensitivity
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
0.97%
2/207 • Number of events 2
|
0.00%
0/196
|
|
Infections and infestations
Abscess
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Infections and infestations
Conjunctivitis
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Infections and infestations
Cystitis
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Infections and infestations
Enterocolitis bacterial
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Infections and infestations
Enterocolitis viral
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Infections and infestations
Gastroenteritis
|
0.97%
2/207 • Number of events 2
|
1.0%
2/196 • Number of events 2
|
|
Infections and infestations
Gingivitis
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
1.4%
3/207 • Number of events 3
|
0.00%
0/196
|
|
Infections and infestations
Influenza
|
0.97%
2/207 • Number of events 2
|
1.5%
3/196 • Number of events 4
|
|
Infections and infestations
Localised infection
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Infections and infestations
Nasopharyngitis
|
13.5%
28/207 • Number of events 32
|
17.3%
34/196 • Number of events 42
|
|
Infections and infestations
Oral herpes
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Infections and infestations
Periodontitis
|
0.00%
0/207
|
0.51%
1/196 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
4/207 • Number of events 4
|
0.00%
0/196
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/207
|
1.0%
2/196 • Number of events 2
|
|
Infections and infestations
Viral myocarditis
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Injury, poisoning and procedural complications
Contusion
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.97%
2/207 • Number of events 4
|
0.00%
0/196
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Investigations
Aspartate aminotransferase increased
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Investigations
Endoscopy gastrointestinal
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Investigations
Weight increased
|
4.3%
9/207 • Number of events 9
|
6.1%
12/196 • Number of events 12
|
|
Investigations
White blood cell count decreased
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Investigations
White blood cell count increased
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.97%
2/207 • Number of events 2
|
0.00%
0/196
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Metabolism and nutrition disorders
Lipid metabolism disorder
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Metabolism and nutrition disorders
Obesity
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
3/207 • Number of events 3
|
1.0%
2/196 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
3/207 • Number of events 3
|
1.5%
3/196 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/207
|
1.5%
3/196 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.97%
2/207 • Number of events 2
|
0.00%
0/196
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/207
|
1.0%
2/196 • Number of events 2
|
|
Nervous system disorders
Dementia alzheimer's type
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Nervous system disorders
Diabetic neuropathy
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Nervous system disorders
Dizziness
|
0.48%
1/207 • Number of events 1
|
1.0%
2/196 • Number of events 2
|
|
Nervous system disorders
Dizziness postural
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Nervous system disorders
Headache
|
0.48%
1/207 • Number of events 1
|
2.0%
4/196 • Number of events 16
|
|
Nervous system disorders
Hyperaesthesia
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
1.4%
3/207 • Number of events 3
|
0.00%
0/196
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Nervous system disorders
Parosmia
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Nervous system disorders
Sciatica
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Nervous system disorders
Somnolence
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/207
|
1.0%
2/196 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
0.48%
1/207 • Number of events 1
|
1.0%
2/196 • Number of events 2
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Renal and urinary disorders
Calculus ureteric
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Renal and urinary disorders
Polyuria
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.76%
1/131 • Number of events 1
|
0.00%
0/119
|
|
Reproductive system and breast disorders
Menstruation delayed
|
1.3%
1/76 • Number of events 1
|
0.00%
0/77
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.97%
2/207 • Number of events 2
|
1.5%
3/196 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.97%
2/207 • Number of events 2
|
0.51%
1/196 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.48%
1/207 • Number of events 1
|
1.0%
2/196 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.48%
1/207 • Number of events 1
|
0.51%
1/196 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.97%
2/207 • Number of events 2
|
0.00%
0/196
|
|
Surgical and medical procedures
Incisional drainage
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Surgical and medical procedures
Large intestinal polypectomy
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
|
Surgical and medical procedures
Tooth extraction
|
0.48%
1/207 • Number of events 2
|
1.0%
2/196 • Number of events 2
|
|
Surgical and medical procedures
Vocal cord nodule removal
|
0.00%
0/207
|
0.51%
1/196 • Number of events 1
|
|
Vascular disorders
Arteriosclerosis
|
0.97%
2/207 • Number of events 2
|
0.51%
1/196 • Number of events 1
|
|
Vascular disorders
Hypertension
|
1.4%
3/207 • Number of events 3
|
1.0%
2/196 • Number of events 2
|
|
Vascular disorders
Varicose vein
|
0.48%
1/207 • Number of events 1
|
0.00%
0/196
|
Additional Information
Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60