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Comparison of Insulin Mix25 Versus Mix50 (CLASSIFY)

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ClinicalTrials.gov Identifier: NCT01773473
Recruitment Status : Completed
First Posted : January 23, 2013
Results First Posted : May 21, 2015
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Insulin Lispro Mix25
Drug: Insulin Lispro Mix50
Enrollment 403

Recruitment Details  
Pre-assignment Details This study consisted of a 26-week treatment period (12-week, weekly-intensive, dose-adjustment period and 14-week maintenance period).
Arm/Group Title Insulin Lispro Mix25 Insulin Lispro Mix50
Hide Arm/Group Description Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks. Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
Period Title: Overall Study
Started 207 196
Received at Least 1 Dose of Study Drug 207 196
Completed 191 177
Not Completed 16 19
Reason Not Completed
Adverse Event             3             2
Protocol Violation             0             4
Physician Decision             3             5
Sponsor Decision             2             0
Lack of Efficacy             0             1
Non-Compliance with study drug             1             4
Withdrawal by Subject             5             3
Lost to Follow-up             2             0
Arm/Group Title Insulin Lispro Mix25 Insulin Lispro Mix50 Total
Hide Arm/Group Description Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks. Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks. Total of all reporting groups
Overall Number of Baseline Participants 207 196 403
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants 196 participants 403 participants
55.74  (10.026) 57.34  (9.664) 56.52  (9.871)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 196 participants 403 participants
Female
76
  36.7%
77
  39.3%
153
  38.0%
Male
131
  63.3%
119
  60.7%
250
  62.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 196 participants 403 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
192
  92.8%
182
  92.9%
374
  92.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
15
   7.2%
14
   7.1%
29
   7.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 196 participants 403 participants
Turkey 15 14 29
Japan 88 84 172
China 80 76 156
Korea, Republic of 24 22 46
Duration of Type-2 Diabetes Mellitus (T2DM)  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants 196 participants 403 participants
9.74  (6.169) 9.15  (6.336) 9.45  (6.250)
1.Primary Outcome
Title Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
Hide Description 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.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro Mix25 Insulin Lispro Mix50
Hide Arm/Group Description:
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
Overall Number of Participants Analyzed 192 179
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage of glycosylated hemoglobin
-1.52
(-1.66 to -1.39)
-1.69
(-1.83 to -1.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro Mix25, Insulin Lispro Mix50
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analyses were based on a pre-defined non-inferiority margin of 0.4%.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-0.01 to 0.35
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26
Hide Description 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.
Time Frame Baseline through Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro Mix25 Insulin Lispro Mix50
Hide Arm/Group Description:
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
Overall Number of Participants Analyzed 207 196
Measure Type: Number
Unit of Measure: percentage of participants
<7.0% 45.9 59.7
≤6.5% 26.1 42.3
3.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (FBG) at Week 26
Hide Description 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.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro Mix25 Insulin Lispro Mix50
Hide Arm/Group Description:
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
Overall Number of Participants Analyzed 207 196
Least Squares Mean (95% Confidence Interval)
Unit of Measure: millimoles per liter (mmol/L)
-2.37
(-2.68 to -2.06)
-1.99
(-2.30 to -1.68)
4.Secondary Outcome
Title Change From Baseline in Body Weight at Week 26
Hide Description 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.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had baseline and Week 26 body weight measurements.
Arm/Group Title Insulin Lispro Mix25 Insulin Lispro Mix50
Hide Arm/Group Description:
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
Overall Number of Participants Analyzed 207 196
Least Squares Mean (95% Confidence Interval)
Unit of Measure: kilogram (kg)
2.31
(1.85 to 2.77)
2.32
(1.84 to 2.79)
5.Secondary Outcome
Title Number of Hypoglycemic Events Baseline Through Week 26 (Incidence)
Hide Description 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].
Time Frame Baseline through Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Insulin Lispro Mix25 Insulin Lispro Mix50
Hide Arm/Group Description:
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
Overall Number of Participants Analyzed 207 196
Measure Type: Number
Unit of Measure: events
All Hypoglycemic Events 568 583
Severe Hypoglycemic Events 0 1
6.Secondary Outcome
Title Insulin Dose at Week 26
Hide Description Insulin dose is the total daily dose including basal and prandial doses.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro Mix25 Insulin Lispro Mix50
Hide Arm/Group Description:
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
Overall Number of Participants Analyzed 207 196
Mean (Standard Deviation)
Unit of Measure: units of insulin per day (IU/day)
40.02  (17.771) 39.32  (17.991)
7.Secondary Outcome
Title Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
Hide Description 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.
Time Frame Baseline, Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro Mix25 Insulin Lispro Mix50
Hide Arm/Group Description:
Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
Overall Number of Participants Analyzed 207 196
Least Squares Mean (95% Confidence Interval)
Unit of Measure: micrograms/milliliter (µg/mL)
4.24
(3.39 to 5.10)
5.62
(4.74 to 6.51)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Insulin Lispro Mix25 Insulin Lispro Mix50
Hide Arm/Group Description Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks. Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
All-Cause Mortality
Insulin Lispro Mix25 Insulin Lispro Mix50
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Insulin Lispro Mix25 Insulin Lispro Mix50
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/207 (3.86%)      7/196 (3.57%)    
Cardiac disorders     
Acute myocardial infarction  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Cardiac failure  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Coronary artery disease  1  1/207 (0.48%)  1 1/196 (0.51%)  1
Tachycardia  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Immune system disorders     
Anaphylactic reaction  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Infections and infestations     
Bacteraemia  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Injury, poisoning and procedural complications     
Lumbar vertebral fracture  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Stab wound  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Musculoskeletal and connective tissue disorders     
Spinal osteoarthritis  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Lymphoma  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Nervous system disorders     
Brain stem infarction  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Cerebellar infarction  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Insulin Lispro Mix25 Insulin Lispro Mix50
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   87/207 (42.03%)      84/196 (42.86%)    
Cardiac disorders     
Angina pectoris  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Congestive cardiomyopathy  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Palpitations  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Ear and labyrinth disorders     
Tinnitus  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Vertigo  1  2/207 (0.97%)  2 0/196 (0.00%)  0
Eye disorders     
Arteriosclerotic retinopathy  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Cataract  1  1/207 (0.48%)  1 1/196 (0.51%)  1
Diabetic retinopathy  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Dry eye  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Glaucoma  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Keratitis  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Ocular hyperaemia  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Punctate keratitis  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Gastrointestinal disorders     
Abdominal discomfort  1  1/207 (0.48%)  1 2/196 (1.02%)  2
Abdominal pain  1  0/207 (0.00%)  0 1/196 (0.51%)  2
Abdominal pain upper  1  1/207 (0.48%)  1 1/196 (0.51%)  1
Constipation  1  2/207 (0.97%)  2 3/196 (1.53%)  6
Dental caries  1  0/207 (0.00%)  0 4/196 (2.04%)  4
Diarrhoea  1  1/207 (0.48%)  1 7/196 (3.57%)  8
Dyspepsia  1  0/207 (0.00%)  0 3/196 (1.53%)  3
Faecaloma  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Gastritis  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Gastritis atrophic  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Gastrooesophageal reflux disease  1  1/207 (0.48%)  1 1/196 (0.51%)  1
Gingival pain  1  1/207 (0.48%)  1 1/196 (0.51%)  1
Large intestine polyp  1  1/207 (0.48%)  1 2/196 (1.02%)  2
Melaena  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Mouth ulceration  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Nausea  1  2/207 (0.97%)  2 2/196 (1.02%)  3
Oesophageal discomfort  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Oesophagitis  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Periodontal disease  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Stomatitis  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Toothache  1  1/207 (0.48%)  1 1/196 (0.51%)  1
General disorders     
Asthenia  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Chest pain  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Feeling abnormal  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Injection site bruising  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Injection site erythema  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Injection site haemorrhage  1  1/207 (0.48%)  2 0/196 (0.00%)  0
Injection site induration  1  2/207 (0.97%)  2 0/196 (0.00%)  0
Injection site pain  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Injection site pruritus  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Injection site reaction  1  0/207 (0.00%)  0 2/196 (1.02%)  2
Local swelling  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Hepatobiliary disorders     
Hepatic function abnormal  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Immune system disorders     
Drug hypersensitivity  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Hypersensitivity  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Seasonal allergy  1  2/207 (0.97%)  2 0/196 (0.00%)  0
Infections and infestations     
Abscess  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Acute sinusitis  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Bronchitis  1  1/207 (0.48%)  1 1/196 (0.51%)  1
Cellulitis  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Conjunctivitis  1  1/207 (0.48%)  1 1/196 (0.51%)  1
Conjunctivitis bacterial  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Cystitis  1  1/207 (0.48%)  1 1/196 (0.51%)  1
Enterocolitis bacterial  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Enterocolitis viral  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Gastroenteritis  1  2/207 (0.97%)  2 2/196 (1.02%)  2
Gingivitis  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Herpes zoster  1  3/207 (1.45%)  3 0/196 (0.00%)  0
Influenza  1  2/207 (0.97%)  2 3/196 (1.53%)  4
Localised infection  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Nasopharyngitis  1  28/207 (13.53%)  32 34/196 (17.35%)  42
Oral herpes  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Periodontitis  1  0/207 (0.00%)  0 1/196 (0.51%)  2
Pharyngitis  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Respiratory tract infection  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Tonsillitis  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Upper respiratory tract infection  1  4/207 (1.93%)  4 0/196 (0.00%)  0
Urinary tract infection  1  0/207 (0.00%)  0 2/196 (1.02%)  2
Viral myocarditis  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Injury, poisoning and procedural complications     
Avulsion fracture  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Bone contusion  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Contusion  1  1/207 (0.48%)  1 1/196 (0.51%)  1
Ligament sprain  1  2/207 (0.97%)  4 0/196 (0.00%)  0
Wrist fracture  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Investigations     
Aspartate aminotransferase increased  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Endoscopy gastrointestinal  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Weight increased  1  9/207 (4.35%)  9 12/196 (6.12%)  12
White blood cell count decreased  1  0/207 (0.00%)  0 1/196 (0.51%)  1
White blood cell count increased  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Metabolism and nutrition disorders     
Dyslipidaemia  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Hyperlipidaemia  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Hypertriglyceridaemia  1  2/207 (0.97%)  2 0/196 (0.00%)  0
Hypokalaemia  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Lipid metabolism disorder  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Obesity  1  1/207 (0.48%)  1 1/196 (0.51%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/207 (1.45%)  3 2/196 (1.02%)  2
Back pain  1  3/207 (1.45%)  3 3/196 (1.53%)  3
Exostosis  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Lumbar spinal stenosis  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Musculoskeletal pain  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Musculoskeletal stiffness  1  1/207 (0.48%)  1 1/196 (0.51%)  1
Myalgia  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Osteoarthritis  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Osteoporosis  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Pain in extremity  1  0/207 (0.00%)  0 3/196 (1.53%)  3
Periarthritis  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Tenosynovitis  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Nervous system disorders     
Carotid arteriosclerosis  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Carpal tunnel syndrome  1  2/207 (0.97%)  2 0/196 (0.00%)  0
Cognitive disorder  1  0/207 (0.00%)  0 2/196 (1.02%)  2
Dementia alzheimer's type  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Diabetic neuropathy  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Dizziness  1  1/207 (0.48%)  1 2/196 (1.02%)  2
Dizziness postural  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Headache  1  1/207 (0.48%)  1 4/196 (2.04%)  16
Hyperaesthesia  1  1/207 (0.48%)  1 1/196 (0.51%)  1
Hypoaesthesia  1  3/207 (1.45%)  3 0/196 (0.00%)  0
Loss of consciousness  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Memory impairment  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Neuralgia  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Neuropathy peripheral  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Parosmia  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Sciatica  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Somnolence  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Psychiatric disorders     
Anxiety disorder  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Depression  1  0/207 (0.00%)  0 2/196 (1.02%)  2
Insomnia  1  1/207 (0.48%)  1 2/196 (1.02%)  2
Post-traumatic stress disorder  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Renal and urinary disorders     
Calculus ureteric  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Calculus urinary  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Cystitis noninfective  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Haematuria  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Nephrolithiasis  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Neurogenic bladder  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Polyuria  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Proteinuria  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/131 (0.76%)  1 0/119 (0.00%)  0
Menstruation delayed  1  1/76 (1.32%)  1 0/77 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Cough  1  1/207 (0.48%)  1 1/196 (0.51%)  1
Productive cough  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Rhinorrhoea  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Upper respiratory tract inflammation  1  2/207 (0.97%)  2 3/196 (1.53%)  3
Skin and subcutaneous tissue disorders     
Dermatitis  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Dermatitis contact  1  1/207 (0.48%)  1 1/196 (0.51%)  1
Eczema  1  2/207 (0.97%)  2 1/196 (0.51%)  1
Pruritus  1  1/207 (0.48%)  1 2/196 (1.02%)  2
Rash  1  1/207 (0.48%)  1 1/196 (0.51%)  1
Skin erosion  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Skin fissures  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Urticaria  1  2/207 (0.97%)  2 0/196 (0.00%)  0
Surgical and medical procedures     
Incisional drainage  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Large intestinal polypectomy  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Tooth extraction  1  1/207 (0.48%)  2 2/196 (1.02%)  2
Vocal cord nodule removal  1  0/207 (0.00%)  0 1/196 (0.51%)  1
Vascular disorders     
Arteriosclerosis  1  2/207 (0.97%)  2 1/196 (0.51%)  1
Hypertension  1  3/207 (1.45%)  3 2/196 (1.02%)  2
Varicose vein  1  1/207 (0.48%)  1 0/196 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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
Name/Title: Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01773473     History of Changes
Other Study ID Numbers: 14675
F3Z-CR-IOQI ( Other Identifier: Eli Lilly and Company )
First Submitted: January 18, 2013
First Posted: January 23, 2013
Results First Submitted: May 4, 2015
Results First Posted: May 21, 2015
Last Update Posted: May 21, 2015