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Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy

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ClinicalTrials.gov Identifier: NCT01474538
Recruitment Status : Completed
First Posted : November 18, 2011
Results First Posted : March 20, 2014
Last Update Posted : March 20, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Insulin Lispro
Drug: Insulin Aspart
Enrollment 122
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Insulin Lispro / Insulin Aspart Insulin Aspart / Insulin Lispro
Hide Arm/Group Description Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2. Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
Period Title: Treatment Period 1
Started 60 62
Received at Least 1 Dose of Study Drug 60 62
Completed 57 58
Not Completed 3 4
Reason Not Completed
Death             1             0
Physician Decision             1             0
Withdrawal by Subject             1             3
Protocol Violation             0             1
Period Title: Treatment Period 2
Started 57 58
Received at Least 1 Dose of Study Drug 57 58
Completed 51 56
Not Completed 6 2
Reason Not Completed
Death             1             0
Adverse Event             1             1
Withdrawal by Subject             2             0
Sponsor decision             1             0
Physician Decision             0             1
Protocol Violation             1             0
Arm/Group Title Insulin Lispro / Insulin Aspart Insulin Aspart / Insulin Lispro Total
Hide Arm/Group Description Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2. Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2. Total of all reporting groups
Overall Number of Baseline Participants 60 62 122
Hide Baseline Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 62 participants 122 participants
58.73  (10.41) 60.40  (9.72) 59.58  (10.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 62 participants 122 participants
Female
33
  55.0%
32
  51.6%
65
  53.3%
Male
27
  45.0%
30
  48.4%
57
  46.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 62 participants 122 participants
American Indian or Alaska Native
1
   1.7%
0
   0.0%
1
   0.8%
Asian
0
   0.0%
2
   3.2%
2
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   8.3%
5
   8.1%
10
   8.2%
White
53
  88.3%
54
  87.1%
107
  87.7%
More than one race
1
   1.7%
1
   1.6%
2
   1.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 62 participants 122 participants
Hispanic or Latino 2 1 3
Not Hispanic or Latino 58 61 119
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 62 participants 122 participants
60 62 122
1.Primary Outcome
Title Glycosylated Hemoglobin A1C (HbA1c) at Endpoint
Hide Description Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over the last 8-12 weeks. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline HbA1c (>8% or ≤8%) and participants.
Time Frame After 16 weeks of each treatment (Periods1 and 2)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had HbA1c measured at Week 16 of treatment Period 1 or 2. Participants were analyzed based on the treatment they received.
Arm/Group Title Insulin Lispro Insulin Aspart
Hide Arm/Group Description:
Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 112 111
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycosylated hemoglobin
7.50  (0.12) 7.40  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper limit of the 95% confidence interval (CI) was below 0.4%, lispro was declared non-inferior to aspart.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.002 to 0.210
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Total Daily Insulin Dose
Hide Description Total daily insulin dose was the average of the last 3 days total insulin dose immediately prior to the Week 16 (endpoint) visit of each treatment period. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%) and participants.
Time Frame Week 16 of each treatment (Periods 1 and 2)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had total daily insulin dose recorded during Treatment Period (TP) 1 or 2. If endpoint data was missing for a specific TP, last observation carried forward (LOCF) method was implemented for that respective TP. Participants were analyzed based on the treatment they received.
Arm/Group Title Insulin Lispro Insulin Aspart
Hide Arm/Group Description:
Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 116 117
Least Squares Mean (Standard Error)
Unit of Measure: units of insulin
80.41  (4.78) 80.69  (4.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-2.92 to 2.35
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Rate of Hypoglycemic Events Per 30 Days
Hide Description A hypoglycemic 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 blood glucose concentration of ≤70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)]. Least Squares (LS) means were adjusted for treatment, period, sequence, baseline hypoglycemic event rate, thiazolidinedione use (Yes/No) and baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%).
Time Frame Baseline through 16 weeks of each treatment (Periods 1 and 2)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.
Arm/Group Title Insulin Lispro Insulin Aspart
Hide Arm/Group Description:
Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 118 119
Least Squares Mean (Standard Error)
Unit of Measure: hypoglycemic events per 30 days
2.24  (0.28) 2.38  (0.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.522
Comments [Not Specified]
Method Negative binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Ratio
Estimated Value 0.94
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Weight
Hide Description Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%), baseline weight and participants.
Time Frame Baseline, Week 16 of treatment Periods 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had weight measured at baseline and Week 16 of Treatment Period 1 or 2. Participants were analyzed based on the treatment they received.
Arm/Group Title Insulin Lispro Insulin Aspart
Hide Arm/Group Description:
Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 116 117
Least Squares Mean (Standard Error)
Unit of Measure: kilograms (kg)
0.31  (0.53) 0.89  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.216
Comments [Not Specified]
Method Grizzle Model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.58
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Hypoglycemic Events
Hide Description A hypoglycemic 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 blood glucose concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)]. The percentage of participants is the total number of participants experiencing hypoglycemic events divided by number of participants in the treatment arm multiplied by 100.
Time Frame Baseline through 16 weeks of each treatment (Periods 1 and 2)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.
Arm/Group Title Insulin Lispro Insulin Aspart
Hide Arm/Group Description:
Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
Overall Number of Participants Analyzed 118 119
Measure Type: Number
Unit of Measure: percentage of participants
71.2 74.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.471
Comments [Not Specified]
Method Prescott test
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Insulin Lispro Insulin Aspart
Hide Arm/Group Description Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2. Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
All-Cause Mortality
Insulin Lispro Insulin Aspart
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Insulin Lispro Insulin Aspart
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/118 (12.71%)      14/119 (11.76%)    
Cardiac disorders     
Atrial fibrillation  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Cardiac failure congestive  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Coronary artery disease  1  3/118 (2.54%)  3 1/119 (0.84%)  1
Myocardial infarction  1 [1]  1/118 (0.85%)  1 1/119 (0.84%)  1
Stress cardiomyopathy  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Lower gastrointestinal haemorrhage  1  1/118 (0.85%)  1 0/119 (0.00%)  0
General disorders     
Chest pain  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Non-cardiac chest pain  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Infections and infestations     
Infusion site abscess  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Pneumonia  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Injury, poisoning and procedural complications     
Laceration  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Subdural haematoma  1 [2]  1/118 (0.85%)  1 0/119 (0.00%)  0
Upper limb fracture  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Investigations     
International normalised ratio decreased  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Hypoglycaemia  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Nervous system disorders     
Convulsion  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Hypoaesthesia  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Syncope  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Transient ischaemic attack  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Reproductive system and breast disorders     
Epididymitis  1  0/55 (0.00%)  0 1/55 (1.82%)  1
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Pulmonary embolism  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Respiratory failure  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Peripheral arterial occlusive disease  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
[1]
Event resulted in death in Insulin Aspart group.
[2]
Event resulted in death.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Insulin Lispro Insulin Aspart
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   59/118 (50.00%)      62/119 (52.10%)    
Blood and lymphatic system disorders     
Leukocytosis  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Cardiac disorders     
Acute coronary syndrome  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Atrial fibrillation  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Atrioventricular block first degree  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Cardiac failure congestive  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Cardiac flutter  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Cardiomyopathy  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Ear and labyrinth disorders     
Eustachian tube dysfunction  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Tinnitus  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Vertigo  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Endocrine disorders     
Hypothyroidism  1  1/118 (0.85%)  1 2/119 (1.68%)  2
Eye disorders     
Conjunctivitis  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Iritis  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Lacrimation increased  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Gastrointestinal disorders     
Abdominal discomfort  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Abdominal distension  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Diarrhoea  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Gastrooesophageal reflux disease  1  0/118 (0.00%)  0 2/119 (1.68%)  2
Nausea  1  5/118 (4.24%)  5 2/119 (1.68%)  2
Pancreatitis  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Parotid gland inflammation  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Rectal haemorrhage  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Tongue ulceration  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Tooth impacted  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Vomiting  1  1/118 (0.85%)  1 0/119 (0.00%)  0
General disorders     
Chest discomfort  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Chest pain  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Facial pain  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Fatigue  1  4/118 (3.39%)  4 4/119 (3.36%)  4
Injection site haematoma  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Injection site nodule  1  2/118 (1.69%)  2 2/119 (1.68%)  2
Non-cardiac chest pain  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Oedema  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Oedema peripheral  1  0/118 (0.00%)  0 2/119 (1.68%)  2
Pyrexia  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Immune system disorders     
Multiple allergies  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Seasonal allergy  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Infections and infestations     
Bacteraemia  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Bronchitis  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Ear infection  1  1/118 (0.85%)  1 1/119 (0.84%)  2
Fungal infection  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Gastroenteritis viral  1  3/118 (2.54%)  3 0/119 (0.00%)  0
Herpes zoster  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Influenza  1  2/118 (1.69%)  2 2/119 (1.68%)  2
Infusion site infection  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Labyrinthitis  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Lower respiratory tract infection  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Nasopharyngitis  1  5/118 (4.24%)  5 5/119 (4.20%)  6
Onychomycosis  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Osteomyelitis  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Pharyngitis streptococcal  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Post procedural infection  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Sepsis  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Sinusitis  1  3/118 (2.54%)  3 4/119 (3.36%)  4
Staphylococcal bacteraemia  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Staphylococcal infection  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Subcutaneous abscess  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Tooth abscess  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Tooth infection  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Upper respiratory tract infection  1  2/118 (1.69%)  3 0/119 (0.00%)  0
Urinary tract infection  1  0/118 (0.00%)  0 3/119 (2.52%)  3
Viral infection  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Injury, poisoning and procedural complications     
Arthropod bite  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Contusion  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Fall  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Fibula fracture  1  0/118 (0.00%)  0 2/119 (1.68%)  2
Ligament sprain  1  0/118 (0.00%)  0 2/119 (1.68%)  2
Meniscus lesion  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Muscle strain  1  2/118 (1.69%)  2 1/119 (0.84%)  1
Periorbital haematoma  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Post procedural swelling  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Road traffic accident  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Wound  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Investigations     
Angiogram peripheral  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Blood potassium increased  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Blood sodium decreased  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Cardiac murmur  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Catheterisation cardiac  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Glycosylated haemoglobin increased  1  2/118 (1.69%)  2 2/119 (1.68%)  2
International normalised ratio decreased  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Pulse pressure decreased  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Transaminases increased  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Metabolism and nutrition disorders     
Dehydration  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Dyslipidaemia  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Hypercholesterolaemia  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Hyperlipidaemia  1  2/118 (1.69%)  2 2/119 (1.68%)  2
Vitamin d deficiency  1  0/118 (0.00%)  0 3/119 (2.52%)  3
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/118 (0.85%)  2 0/119 (0.00%)  0
Back pain  1  3/118 (2.54%)  3 4/119 (3.36%)  4
Bunion  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Exostosis  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Fibromyalgia  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Muscle spasms  1  0/118 (0.00%)  0 2/119 (1.68%)  2
Musculoskeletal pain  1  3/118 (2.54%)  3 3/119 (2.52%)  3
Osteoarthritis  1  2/118 (1.69%)  2 1/119 (0.84%)  1
Pain in extremity  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Rotator cuff syndrome  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin cancer  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Skin papilloma  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Thyroid cancer  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Nervous system disorders     
Carotid artery occlusion  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Diabetic neuropathy  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Dizziness  1  2/118 (1.69%)  2 1/119 (0.84%)  1
Essential tremor  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Headache  1  0/118 (0.00%)  0 3/119 (2.52%)  3
Migraine  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Neuropathy peripheral  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Paraesthesia  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Psychiatric disorders     
Depression  1  3/118 (2.54%)  3 3/119 (2.52%)  3
Insomnia  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Renal and urinary disorders     
Dysuria  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Incontinence  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Nephrolithiasis  1  0/118 (0.00%)  0 2/119 (1.68%)  2
Pollakiuria  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Renal failure  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Urinary incontinence  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Reproductive system and breast disorders     
Cystocele  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Dysmenorrhoea  1  1/63 (1.59%)  1 1/64 (1.56%)  2
Prostatitis  1  1/55 (1.82%)  1 0/55 (0.00%)  0
Rectocele  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Uterine prolapse  1  0/63 (0.00%)  0 1/64 (1.56%)  1
Respiratory, thoracic and mediastinal disorders     
Adenoidal hypertrophy  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Asthma  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Cough  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Dyspnoea  1  2/118 (1.69%)  2 2/119 (1.68%)  2
Dyspnoea exertional  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Epistaxis  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Hypoxia  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Oropharyngeal pain  1  2/118 (1.69%)  2 1/119 (0.84%)  1
Pneumonitis  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Pulmonary oedema  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Respiratory tract congestion  1  0/118 (0.00%)  0 2/119 (1.68%)  2
Rhinitis allergic  1  1/118 (0.85%)  1 5/119 (4.20%)  5
Sinus congestion  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Sneezing  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Throat irritation  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Skin and subcutaneous tissue disorders     
Ecchymosis  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Erythema  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Photosensitivity reaction  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Surgical and medical procedures     
Arterial repair  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Coronary angioplasty  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Foraminotomy  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Gastric banding  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Mole excision  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Rotator cuff repair  1  0/118 (0.00%)  0 1/119 (0.84%)  1
Spinal fusion surgery  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Spinal laminectomy  1  1/118 (0.85%)  1 0/119 (0.00%)  0
Vascular disorders     
Angiopathy  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Deep vein thrombosis  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Flushing  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Hypertension  1  2/118 (1.69%)  2 2/119 (1.68%)  2
Intermittent claudication  1  1/118 (0.85%)  1 1/119 (0.84%)  1
Peripheral vascular disorder  1  2/118 (1.69%)  2 2/119 (1.68%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01474538     History of Changes
Other Study ID Numbers: 14207
F3Z-MC-IOQH ( Other Identifier: Eli Lilly and Company )
First Submitted: November 15, 2011
First Posted: November 18, 2011
Results First Submitted: February 4, 2014
Results First Posted: March 20, 2014
Last Update Posted: March 20, 2014