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A Study on the Effect of 2 Pen Devices on HbA1c

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00985712
Collaborator
(none)
263
Enrollment
29
Locations
2
Arms
21
Duration (Months)
9.1
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test the hypothesis that the HumaPen Memoir with memory function, when used over 24 weeks for prandial insulin injections achieves superior glycemic control, when compared to the conventional HumaPen Luxura without memory function.

Condition or Disease Intervention/Treatment Phase
  • Drug: Insulin Lispro
  • Drug: Huminsulin Regular
  • Device: HumaPen Memoir
  • Device: HumaPen Luxura
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
263 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label Study on the Effects of Insulin Pen Devices on Glycemic Control in Children, Adolescents and Adults With Type 1 Diabetes: Novel Pen With Memory Function (HumaPen Memoir) vs. Conventional Pen Without Memory Function (HumaPen Luxura)
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: HumaPen Luxura

Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks

Drug: Insulin Lispro
subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks
Other Names:
  • Humalog
  • LY275585

    • Drug: Huminsulin Regular
    subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks
    Other Names:
  • Huminsulin Normal
  • LY041001

    • Device: HumaPen Luxura
    subcutaneously, daily for 24 weeks
    Experimental: HumaPen Memoir

    Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks

    Drug: Insulin Lispro
    subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks
    Other Names:
  • Humalog
  • LY275585

    • Drug: Huminsulin Regular
    subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks
    Other Names:
  • Huminsulin Normal
  • LY041001

    • Device: HumaPen Memoir
    subcutaneously, daily for 24 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint [Baseline, Week 24]

      HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean values were controlled for treatment, visit, treatment*visit interaction, screening HbA1c (≤9% / >9%), change of prandial insulin at baseline, and baseline HbA1c.

    Secondary Outcome Measures

    1. Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint [Week 24]

    2. Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint [Week 24]

      IDSQ is used to evaluate acceptance of study pen. Willingness to continue was assessed by a single question, rated from 1 to 5 (1=Definitely unwilling and 5=Definitely willing). Higher score indicates stronger desire to continue. Least Squares (LS) Mean values were controlled for treatment and baseline score.

    3. 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24 [Baseline through Week 24]

      Hypoglycemic episode is defined as blood glucose measurement ≤3.9 millimoles/Liter (mmol/L; 70 milligrams/deciliter [mg/dL]). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.

    4. 30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24 [Baseline through Week 24]

      Hyperglycemic episode is defined as blood glucose measurement >18 mmol/L (324 mg/dL). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Type 1 diabetes mellitus

    • receiving at least 3 prandial injections per day with short-acting or analogue insulin

    Exclusion Criteria:

    • Insulin pump therapy

    • receiving pre-mixed insulin preparations

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Aschaffenburg Germany 63739
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Asslar Germany 35614
    3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bad Mergentheim Germany 97980
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Berlin Germany 14089
    5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bosenheim Germany 55545
    6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Diez Germany 65582
    7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dresden Germany 01307
    8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Erlangen Germany 91054
    9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Essen Germany 45355
    10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Falkensee Germany 14612
    11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Flensburg Germany D-24939
    12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Frankfurt Germany 60388
    13 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fulda Germany 36037
    14 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Giessen Germany 35385
    15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hamburg Germany 21073
    16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hannover Germany 30173
    17 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Herdecke Germany 58313
    18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Leipzig Germany 04103
    19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mainz Germany 55116
    20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Münster Germany 48153
    21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Neuwied Germany 56564
    22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rehlingen-Siersburg Germany 66780
    23 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rotenburg-Fulda Germany 36199
    24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saarbrücken Germany 66121
    25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Schkeuditz Germany 04435
    26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Schwedt/Oder Germany 16303
    27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tuebingen Germany 72076
    28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Warburg Germany 34414
    29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wuppertal Germany 42283

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST, Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT00985712
    Other Study ID Numbers:
    • 12704
    • H9D-SB-ITAE
    First Posted:
    Sep 28, 2009
    Last Update Posted:
    Jun 4, 2012
    Last Verified:
    May 1, 2012
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 1
    Insulin Lispro

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title HumaPen Luxura HumaPen Memoir
    Arm/Group Description Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
    Period Title: Overall Study
    STARTED 133 130
    Received at Least One Dose of Study Drug 131 130
    Full Analysis Set (FAS) 128 129
    COMPLETED 127 123
    NOT COMPLETED 6 7

    Baseline Characteristics

    Arm/Group Title HumaPen Luxura HumaPen Memoir Total
    Arm/Group Description Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks Total of all reporting groups
    Overall Participants 128 129 257
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    41.2
    (15.52)
    38.3
    (17.37)
    39.8
    (16.5)
    Sex: Female, Male (Count of Participants)
    Female
    52
    40.6%
    56
    43.4%
    108
    42%
    Male
    76
    59.4%
    73
    56.6%
    149
    58%
    Race/Ethnicity, Customized (participants) [Number]
    White
    127
    99.2%
    128
    99.2%
    255
    99.2%
    Black or African American
    1
    0.8%
    1
    0.8%
    2
    0.8%
    Region of Enrollment (participants) [Number]
    Germany
    128
    100%
    129
    100%
    257
    100%
    Hemoglobin A1c (HbA1c) (percentage of glycosylated hemoglobin) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [percentage of glycosylated hemoglobin]
    9.06
    (0.93)
    9.12
    (1.04)
    9.09
    (0.99)

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint
    Description HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean values were controlled for treatment, visit, treatment*visit interaction, screening HbA1c (≤9% / >9%), change of prandial insulin at baseline, and baseline HbA1c.
    Time Frame Baseline, Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in full analysis population set with missing values accounted for using mixed model repeated measures (MMRM).
    Arm/Group Title HumaPen Luxura HumaPen Memoir
    Arm/Group Description Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
    Measure Participants 128 129
    Least Squares Mean (95% Confidence Interval) [percentage of glycosylated hemoglobin]
    -0.48
    -0.43
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection HumaPen Luxura, HumaPen Memoir
    Comments Superiority criterion is met if the upper limit of Confidence Interval (CI) is below zero.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6692
    Comments
    Method Mixed Models Analysis
    Comments The model details are given in the section of Measure Description.
    Method of Estimation Estimation Parameter LS Mean Difference (Final Values)
    Estimated Value 0.05
    Confidence Interval (2-Sided) 95%
    -0.17 to 0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.11
    Estimation Comments
    2. Secondary Outcome
    Title Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint
    Description
    Time Frame Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in full analysis population set who had Week 24 measurements.
    Arm/Group Title HumaPen Luxura HumaPen Memoir
    Arm/Group Description Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
    Measure Participants 127 127
    HbA1c ≤7.0%
    5.5
    4.3%
    3.1
    2.4%
    HbA1c ≤7.5%
    16.5
    12.9%
    11.0
    8.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection HumaPen Luxura, HumaPen Memoir
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3551
    Comments P-value is for HbA1c ≤7.0%.
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection HumaPen Luxura, HumaPen Memoir
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2026
    Comments P-value is for HbA1c ≤7.5%.
    Method Chi-squared
    Comments
    3. Secondary Outcome
    Title Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint
    Description IDSQ is used to evaluate acceptance of study pen. Willingness to continue was assessed by a single question, rated from 1 to 5 (1=Definitely unwilling and 5=Definitely willing). Higher score indicates stronger desire to continue. Least Squares (LS) Mean values were controlled for treatment and baseline score.
    Time Frame Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in full analysis population set who had Week 24 measurements.
    Arm/Group Title HumaPen Luxura HumaPen Memoir
    Arm/Group Description Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
    Measure Participants 128 126
    Least Squares Mean (95% Confidence Interval) [units on a scale]
    4.06
    4.05
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection HumaPen Luxura, HumaPen Memoir
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9070
    Comments
    Method ANCOVA
    Comments Analysis of covariance (ANCOVA) was adjusted for baseline values.
    4. Secondary Outcome
    Title 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24
    Description Hypoglycemic episode is defined as blood glucose measurement ≤3.9 millimoles/Liter (mmol/L; 70 milligrams/deciliter [mg/dL]). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.
    Time Frame Baseline through Week 24

    Outcome Measure Data

    Analysis Population Description
    Randomized participants who took at least one dose of study drug with post-baseline hypoglycemia follow-up.
    Arm/Group Title HumaPen Luxura HumaPen Memoir
    Arm/Group Description Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
    Measure Participants 130 130
    Mean (Standard Deviation) [number of events per 30 days]
    2.68
    (4.66)
    2.46
    (4.38)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection HumaPen Luxura, HumaPen Memoir
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9817
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    5. Secondary Outcome
    Title 30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24
    Description Hyperglycemic episode is defined as blood glucose measurement >18 mmol/L (324 mg/dL). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.
    Time Frame Baseline through Week 24

    Outcome Measure Data

    Analysis Population Description
    Randomized participants who took at least one dose of study drug with post-baseline hyperglycemia follow-up.
    Arm/Group Title HumaPen Luxura HumaPen Memoir
    Arm/Group Description Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
    Measure Participants 130 130
    Mean (Standard Deviation) [number of events per 30 days]
    2.56
    (5.50)
    3.92
    (9.82)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection HumaPen Luxura, HumaPen Memoir
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1187
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title HumaPen Luxura HumaPen Memoir
    Arm/Group Description Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
    All Cause Mortality
    HumaPen Luxura HumaPen Memoir
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    HumaPen Luxura HumaPen Memoir
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/131 (5.3%) 8/130 (6.2%)
    Gastrointestinal disorders
    Gastritis 0/131 (0%) 0 1/130 (0.8%) 1
    Infections and infestations
    Cystitis 1/131 (0.8%) 1 0/130 (0%) 0
    Pneumonia 2/131 (1.5%) 2 0/130 (0%) 0
    Salpingo-oophoritis 0/131 (0%) 0 1/130 (0.8%) 1
    Upper respiratory tract infection 0/131 (0%) 0 1/130 (0.8%) 1
    Injury, poisoning and procedural complications
    Road traffic accident 0/131 (0%) 0 1/130 (0.8%) 1
    Upper limb fracture 0/131 (0%) 0 1/130 (0.8%) 1
    Investigations
    Glycosylated haemoglobin increased 0/131 (0%) 0 1/130 (0.8%) 1
    Metabolism and nutrition disorders
    Diabetic foot 0/131 (0%) 0 2/130 (1.5%) 2
    Diabetic ketoacidosis 0/131 (0%) 0 1/130 (0.8%) 1
    Hyperglycaemia 1/131 (0.8%) 1 1/130 (0.8%) 1
    Hypoglycaemia 2/131 (1.5%) 2 0/130 (0%) 0
    Musculoskeletal and connective tissue disorders
    Cervical spinal stenosis 0/131 (0%) 0 1/130 (0.8%) 2
    Nervous system disorders
    Cerebrovascular accident 1/131 (0.8%) 1 0/130 (0%) 0
    Other (Not Including Serious) Adverse Events
    HumaPen Luxura HumaPen Memoir
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 52/131 (39.7%) 50/130 (38.5%)
    Blood and lymphatic system disorders
    Anaemia 0/131 (0%) 0 1/130 (0.8%) 1
    Cardiac disorders
    Supraventricular tachycardia 1/131 (0.8%) 1 0/130 (0%) 0
    Ear and labyrinth disorders
    Ear pain 0/131 (0%) 0 1/130 (0.8%) 1
    Tinnitus 2/131 (1.5%) 2 0/130 (0%) 0
    Eye disorders
    Cataract 0/131 (0%) 0 1/130 (0.8%) 1
    Conjunctivitis 1/131 (0.8%) 1 0/130 (0%) 0
    Glaucoma 1/131 (0.8%) 1 0/130 (0%) 0
    Gastrointestinal disorders
    Diarrhoea 1/131 (0.8%) 1 2/130 (1.5%) 2
    Dyspepsia 1/131 (0.8%) 1 0/130 (0%) 0
    Gastritis 0/131 (0%) 0 1/130 (0.8%) 1
    Nausea 0/131 (0%) 0 1/130 (0.8%) 1
    Tooth disorder 0/131 (0%) 0 1/130 (0.8%) 1
    Toothache 0/131 (0%) 0 1/130 (0.8%) 1
    Vomiting 1/131 (0.8%) 1 1/130 (0.8%) 1
    General disorders
    Injection site pain 0/131 (0%) 0 1/130 (0.8%) 1
    Oedema 1/131 (0.8%) 1 0/130 (0%) 0
    Oedema peripheral 2/131 (1.5%) 2 0/130 (0%) 0
    Infections and infestations
    Acute sinusitis 0/131 (0%) 0 1/130 (0.8%) 1
    Bronchitis 1/131 (0.8%) 1 1/130 (0.8%) 1
    Cystitis 2/131 (1.5%) 2 0/130 (0%) 0
    Ear infection 0/131 (0%) 0 1/130 (0.8%) 2
    Epstein-Barr virus infection 1/131 (0.8%) 1 0/130 (0%) 0
    Fungal infection 1/131 (0.8%) 1 0/130 (0%) 0
    Gastroenteritis 1/131 (0.8%) 1 2/130 (1.5%) 2
    Infection 1/131 (0.8%) 1 0/130 (0%) 0
    Influenza 1/131 (0.8%) 1 1/130 (0.8%) 1
    Nasopharyngitis 15/131 (11.5%) 18 12/130 (9.2%) 13
    Pneumonia 0/131 (0%) 0 1/130 (0.8%) 1
    Pyelonephritis 0/131 (0%) 0 1/130 (0.8%) 1
    Scarlet fever 1/131 (0.8%) 1 0/130 (0%) 0
    Sinobronchitis 0/131 (0%) 0 1/130 (0.8%) 1
    Tonsillitis 2/131 (1.5%) 2 1/130 (0.8%) 1
    Urinary tract infection 3/131 (2.3%) 3 2/130 (1.5%) 2
    Viral infection 1/131 (0.8%) 1 1/130 (0.8%) 1
    Injury, poisoning and procedural complications
    Contusion 0/131 (0%) 0 1/130 (0.8%) 1
    Joint sprain 2/131 (1.5%) 2 1/130 (0.8%) 1
    Thermal burn 1/131 (0.8%) 1 1/130 (0.8%) 1
    Wound 2/131 (1.5%) 2 0/130 (0%) 0
    Investigations
    Liver function test abnormal 0/131 (0%) 0 1/130 (0.8%) 1
    Metabolism and nutrition disorders
    Diabetic foot 1/131 (0.8%) 1 2/130 (1.5%) 2
    Hypercholesterolaemia 1/131 (0.8%) 1 1/130 (0.8%) 1
    Hyperlipidaemia 1/131 (0.8%) 1 1/130 (0.8%) 1
    Hypoglycaemia 0/131 (0%) 0 1/130 (0.8%) 1
    Iron deficiency 0/131 (0%) 0 1/130 (0.8%) 1
    Obesity 0/131 (0%) 0 1/130 (0.8%) 1
    Musculoskeletal and connective tissue disorders
    Arthritis 0/131 (0%) 0 1/130 (0.8%) 1
    Back pain 3/131 (2.3%) 3 0/130 (0%) 0
    Joint effusion 0/131 (0%) 0 1/130 (0.8%) 1
    Muscle spasms 0/131 (0%) 0 1/130 (0.8%) 1
    Osteochondrosis 0/131 (0%) 0 1/130 (0.8%) 1
    Tendon pain 0/131 (0%) 0 1/130 (0.8%) 1
    Tenosynovitis 1/131 (0.8%) 1 0/130 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign ovarian tumour 0/131 (0%) 0 1/130 (0.8%) 1
    Nervous system disorders
    Headache 2/131 (1.5%) 2 0/130 (0%) 0
    Migraine 0/131 (0%) 0 1/130 (0.8%) 1
    Polyneuropathy 1/131 (0.8%) 1 0/130 (0%) 0
    Psychiatric disorders
    Anxiety 1/131 (0.8%) 1 0/130 (0%) 0
    Burnout syndrome 0/131 (0%) 0 1/130 (0.8%) 1
    Depression 2/131 (1.5%) 2 0/130 (0%) 0
    Renal and urinary disorders
    Cystitis noninfective 0/131 (0%) 0 1/130 (0.8%) 1
    Nephropathy 0/131 (0%) 0 1/130 (0.8%) 1
    Renal failure 0/131 (0%) 0 1/130 (0.8%) 1
    Renal impairment 0/131 (0%) 0 1/130 (0.8%) 1
    Reproductive system and breast disorders
    Erectile dysfunction 0/131 (0%) 0 1/130 (0.8%) 1
    Respiratory, thoracic and mediastinal disorders
    Cough 1/131 (0.8%) 1 1/130 (0.8%) 1
    Dyspnoea 0/131 (0%) 0 1/130 (0.8%) 1
    Epistaxis 1/131 (0.8%) 1 0/130 (0%) 0
    Oropharyngeal pain 0/131 (0%) 0 1/130 (0.8%) 1
    Rhinitis allergic 0/131 (0%) 0 1/130 (0.8%) 1
    Skin and subcutaneous tissue disorders
    Alopecia 0/131 (0%) 0 1/130 (0.8%) 1
    Dermatitis allergic 1/131 (0.8%) 1 0/130 (0%) 0
    Eczema 1/131 (0.8%) 1 0/130 (0%) 0
    Ingrowing nail 0/131 (0%) 0 1/130 (0.8%) 1
    Intertrigo 0/131 (0%) 0 1/130 (0.8%) 1
    Lipodystrophy acquired 2/131 (1.5%) 2 0/130 (0%) 0
    Lipohypertrophy 1/131 (0.8%) 1 0/130 (0%) 0
    Neuropathic ulcer 0/131 (0%) 0 1/130 (0.8%) 1
    Skin ulcer 1/131 (0.8%) 1 0/130 (0%) 0
    Vascular disorders
    Haematoma 1/131 (0.8%) 1 0/130 (0%) 0
    Hypertension 1/131 (0.8%) 1 0/130 (0%) 0
    Peripheral arterial occlusive disease 0/131 (0%) 0 1/130 (0.8%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT00985712
    Other Study ID Numbers:
    • 12704
    • H9D-SB-ITAE
    First Posted:
    Sep 28, 2009
    Last Update Posted:
    Jun 4, 2012
    Last Verified:
    May 1, 2012