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Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes (IONM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00191282
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : August 4, 2009
Last Update Posted : January 20, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes Mellitus, Type 2
Acute Myocardial Infarction
Interventions Drug: Insulin lispro
Drug: Human insulin isophane suspension (NPH)
Drug: Insulin glargine
Drug: Human insulin isophane suspension
Drug: Human insulin 30/70
Enrollment 1116
Recruitment Details  
Pre-assignment Details One patient was randomized but discontinued prior to treatment and is not included in any of the analyses. In the Participant Flow table, the term study outcome is used to differentiate it from serious adverse events (SAEs). By definition, the study outcomes were all SAEs as it was a cardiovascular outcome trial.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%. Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Period Title: Overall Study
Started 558 558
Completed 338 346
Not Completed 220 212
Reason Not Completed
Adverse Event             5             6
Death             51             51
Lack of Efficacy             11             6
Noncompliance             14             17
Patient moved             11             14
Withdrawal by Subject             59             44
Physician Decision             18             15
Protocol entry criteria not met             14             9
Protocol Violation             9             12
Severity of outcome             2             5
Sponsor's decision             2             2
Lost to Follow-up             24             31
Arm/Group Title Postprandial Fasting Total
Hide Arm/Group Description Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%. Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%. Total of all reporting groups
Overall Number of Baseline Participants 557 558 1115
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 557 participants 558 participants 1115 participants
61.1  (9.7) 60.9  (9.8) 61.0  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 557 participants 558 participants 1115 participants
Female
201
  36.1%
208
  37.3%
409
  36.7%
Male
356
  63.9%
350
  62.7%
706
  63.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 557 participants 558 participants 1115 participants
Slovakia (Slovak Republic) 8 11 19
Slovenia 16 16 32
Spain 5 3 8
Lebanon 18 19 37
Turkey 19 17 36
Israel 38 38 76
Russian Federation 63 65 128
United Kingdom 15 18 33
India 36 34 70
Czech Republic 26 24 50
Hungary 41 41 82
Canada 12 13 25
Poland 102 103 205
Croatia 72 71 143
Romania 33 31 64
South Africa 44 45 89
Germany 9 9 18
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 557 participants 558 participants 1115 participants
Caucasian 484 483 967
Western Asian 61 58 119
African Descent 1 6 7
Other 11 11 22
1.Primary Outcome
Title Number of Participants Who Experienced a Primary Combined Outcome
Hide Description The combined study outcomes consisted of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedures planned after randomization.
Time Frame Randomization (Day 0) until first occurrence of primary combined outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 558
Measure Type: Number
Unit of Measure: participants
174 181
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments To achieve 80% power, 490 pts need to experience primary combined CV outcome to detect diff. between treatments, assuming: >=18.5% reduction in incidence of outcomes, 18 mo. pt recruitment, 18 mo. pt follow-up, 10% annual drop-out rate, 2-yr outcome incidence rate of >=40% (pts in least efficacious treatment), and nominal 2-sided signif. of 0.045.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.866
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Who Experienced Death From Any Cause or Any One of the Primary Outcomes
Hide Description Primary outcomes in this study consisted of: cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedure planned after randomization.
Time Frame Randomization (Day 0) until death from any cause or one of the primary outcomes (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 558
Measure Type: Number
Unit of Measure: participants
178 189
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.715
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Who Experienced Any One of the Primary Outcomes Adjusted for Indicators of Metabolic Control
Hide Description Indicators of metabolic control included glycosylated hemoglobin (HbA1c) and fasting blood glucose concentrations.
Time Frame Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 558
Measure Type: Number
Unit of Measure: participants
174 181
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.914
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants Who Experienced Primary Outcomes Adjusted for Metabolic Control and Major Cardiovascular (CV) Risk Factors
Hide Description Primary outcomes adjusted for major cardiovascular (CV) risk factors (blood pressure, cholesterol [total, high density lipoprotein (HDL), and low density lipoprotein (LDL)], triglycerides, smoking, albuminuria, age, gender, and body mass index (BMI).
Time Frame Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 558
Measure Type: Number
Unit of Measure: participants
174 181
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.706
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.05
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants Who Experienced Death From Any Cause
Hide Description [Not Specified]
Time Frame Randomization (Day 0) until death from any cause (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 558
Measure Type: Number
Unit of Measure: participants
51 51
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.982
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.00
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants Who Experienced Cardiovascular (CV) Death
Hide Description [Not Specified]
Time Frame Randomization (Day 0) until cardiovascular death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 558
Measure Type: Number
Unit of Measure: participants
44 42
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.816
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.05
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants Who Experienced Myocardial Infarction (MI)
Hide Description Occurrence of myocardial infarction (MI) (fatal, nonfatal, any).
Time Frame Randomization (Day 0) until myocardial infarction (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 558
Measure Type: Number
Unit of Measure: participants
63 63
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.948
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants Who Experienced Stroke
Hide Description Occurrence of stroke (fatal, nonfatal, any).
Time Frame Randomization (Day 0) until stroke (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 558
Measure Type: Number
Unit of Measure: participants
20 17
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.581
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.20
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants Who Experienced Hospitalization for Acute Coronary Syndromes (HACS)
Hide Description [Not Specified]
Time Frame Randomization (Day 0) until HACS (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 558
Measure Type: Number
Unit of Measure: participants
58 54
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.647
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.09
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants Who Experienced Coronary Revascularization Procedures
Hide Description Occurrence of all coronary revascularization procedures (angioplasty or coronary artery by-pass surgery) planned after randomization.
Time Frame Randomization (Day 0) until coronary revascularization procedures (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 558
Measure Type: Number
Unit of Measure: participants
84 94
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.525
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants Who Experienced Amputation for Peripheral Vascular Disease Planned After Randomization
Hide Description [Not Specified]
Time Frame Randomization (Day 0) until amputation (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 558
Measure Type: Number
Unit of Measure: participants
9 8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.800
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.13
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Number of Participants Who Experienced Congestive Heart Failure
Hide Description Occurrence of congestive heart failure (newly diagnosed after Visit 2).
Time Frame Randomization (Day 0) until congestive heart failure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 558
Measure Type: Number
Unit of Measure: participants
33 37
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.662
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants Who Experienced Revascularization Procedure for Peripheral Vascular Disease Planned After Randomization
Hide Description [Not Specified]
Time Frame Randomization (Day 0) until revascularization procedure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 558
Measure Type: Number
Unit of Measure: participants
11 12
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.863
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Number of Participants Who Experienced Coronary Angiography Planned After Randomization
Hide Description [Not Specified]
Time Frame Randomization (Day 0) until coronary angiography (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 558
Measure Type: Number
Unit of Measure: participants
75 86
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
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 Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Number of Participants With Self-Reported Hypoglycemia During Month 1
Hide Description Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).
Time Frame Visit 3 (Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 557
Measure Type: Number
Unit of Measure: participants
124 119
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7168
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
16.Secondary Outcome
Title Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 1
Hide Description Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).
Time Frame Visit 3 (Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who self-reported hypoglycemia during Month 1.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 124 119
Measure Type: Number
Unit of Measure: episodes of hypoglycemia
353 302
17.Secondary Outcome
Title Number of Participants With Self-Reported Hypoglycemia During Month 3
Hide Description Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).
Time Frame Visit 4 (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug and who were still in the study.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 511 525
Measure Type: Number
Unit of Measure: participants
160 139
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0860
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
18.Secondary Outcome
Title Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 3
Hide Description Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).
Time Frame Visit 4 (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who self-reported hypoglycemia during Month 3.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 160 139
Measure Type: Number
Unit of Measure: episodes of hypoglycemia
567 524
19.Secondary Outcome
Title Number of Participants With Self-Reported Hypoglycemia During Month 6
Hide Description Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).
Time Frame Visit 5 (Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug and who were still in the study.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 493 504
Measure Type: Number
Unit of Measure: participants
163 145
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1424
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
20.Secondary Outcome
Title Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 6
Hide Description Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).
Time Frame Visit 5 (Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with self-reported hypoglycemia during Month 6.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 163 145
Measure Type: Number
Unit of Measure: episodes of hypoglycemia
770 576
21.Secondary Outcome
Title Number of Participants With Self-Reported Hypoglycemia During Month 9
Hide Description Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).
Time Frame Visit 6 (Month 9)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug and who were still in the study.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 483 488
Measure Type: Number
Unit of Measure: participants
155 138
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1957
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
22.Secondary Outcome
Title Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 9
Hide Description Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).
Time Frame Visit 6 (Month 9)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with self-reported hypoglycemia during Month 9.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 155 138
Measure Type: Number
Unit of Measure: episodes of hypoglycemia
Number of Episodes 747 569
23.Secondary Outcome
Title Number of Participants With Self-Reported Hypoglycemia During Month 12
Hide Description Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).
Time Frame Visit 7 (Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug and who were still in the study.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 470 471
Measure Type: Number
Unit of Measure: participants
146 130
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2434
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
24.Secondary Outcome
Title Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 12
Hide Description Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).
Time Frame Visit 7 (Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with self-reported hypoglycemia during Month 12.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 146 130
Measure Type: Number
Unit of Measure: episodes of hypoglycemia
710 486
25.Secondary Outcome
Title Number of Participants With Self-Reported Hypoglycemia During Month 18
Hide Description Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).
Time Frame Visit 8 (Month 18)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug and who were still in the study.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 452 457
Measure Type: Number
Unit of Measure: participants
143 129
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Postprandial, Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2617
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
26.Secondary Outcome
Title Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 18
Hide Description Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).
Time Frame Visit 8 (Month 18)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with self-reported hypoglycemia during Month 18.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 143 129
Measure Type: Number
Unit of Measure: episodes of hypoglycemia
945 669
27.Other Pre-specified Outcome
Title Summary of Reasons for Deaths
Hide Description [Not Specified]
Time Frame Randomization (Day 0) to death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study drug.
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description:
Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
Overall Number of Participants Analyzed 557 558
Measure Type: Number
Unit of Measure: participants
Fatal MI 12 12
Fatal Stroke 3 2
CV Death other than Stroke/MI 29 28
Non-CV Death 7 8
Unknown 0 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Postprandial Fasting
Hide Arm/Group Description Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%. Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
All-Cause Mortality
Postprandial Fasting
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Postprandial Fasting
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   145      142    
Blood and lymphatic system disorders     
Anaemia  1  1/557 (0.18%)  1 1/558 (0.18%)  1
Hypochromic anaemia  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Iron deficiency anaemia  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Normochromic normocytic anaemia  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Cardiac disorders     
Acute coronary syndrome  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Acute left ventricular failure  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Acute myocardial infarction  1  0/557 (0.00%)  0 2/558 (0.36%)  2
Angina pectoris  1  3/557 (0.54%)  3 3/558 (0.54%)  3
Angina unstable  1  2/557 (0.36%)  2 1/558 (0.18%)  1
Atrial fibrillation  1  2/557 (0.36%)  2 7/558 (1.25%)  7
Atrial flutter  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Atrioventricular block  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Atrioventricular block complete  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Atrioventricular block second degree  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Cardiac failure  1  2/557 (0.36%)  2 1/558 (0.18%)  1
Cardiac failure chronic  1  0/557 (0.00%)  0 2/558 (0.36%)  2
Cardiac failure congestive  1  8/557 (1.44%)  8 8/558 (1.43%)  8
Conduction disorder  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Coronary artery insufficiency  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Coronary artery restenosis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Dressler's syndrome  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Intracardiac thrombus  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Left ventricular dysfunction  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Left ventricular failure  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Mitral valve incompetence  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Myocardial infarction  1  1/557 (0.18%)  1 2/558 (0.36%)  2
Sick sinus syndrome  1  2/557 (0.36%)  2 2/558 (0.36%)  2
Sinus bradycardia  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Ventricular extrasystoles  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Ventricular fibrillation  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Ventricular tachyarrhythmia  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Ventricular tachycardia  1  2/557 (0.36%)  2 1/558 (0.18%)  1
Ear and labyrinth disorders     
Hearing impaired  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Sudden hearing loss  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Vertigo  1  2/557 (0.36%)  2 0/558 (0.00%)  0
Vestibular neuronitis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Endocrine disorders     
Hyperthyroidism  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Eye disorders     
Cataract  1  3/557 (0.54%)  3 1/558 (0.18%)  1
Conjunctivitis  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Diabetic retinopathy  1  2/557 (0.36%)  2 1/558 (0.18%)  1
Glaucoma  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Retinal detachment  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Vitreous haemorrhage  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  2/557 (0.36%)  2 2/558 (0.36%)  2
Abdominal pain upper  1  1/557 (0.18%)  1 2/558 (0.36%)  2
Anal haemorrhage  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Colonic polyp  1  1/557 (0.18%)  1 1/558 (0.18%)  1
Diarrhoea  1  1/557 (0.18%)  1 1/558 (0.18%)  1
Duodenitis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Dyspepsia  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Enteritis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Enterocolitis  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Gastric polyps  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Gastric ulcer haemorrhage  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Gastritis  1  3/557 (0.54%)  3 2/558 (0.36%)  2
Gastritis erosive  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Gastrointestinal haemorrhage  1  2/557 (0.36%)  2 0/558 (0.00%)  0
Gastrointestinal telangiectasia  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Gastrooesophageal reflux disease  1  0/557 (0.00%)  0 2/558 (0.36%)  2
Haemorrhoids  1  1/557 (0.18%)  1 1/558 (0.18%)  1
Hiatus hernia  1  1/557 (0.18%)  1 2/558 (0.36%)  2
Ileus  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Inguinal hernia  1  2/557 (0.36%)  2 0/558 (0.00%)  0
Intestinal obstruction  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Melaena  1  0/557 (0.00%)  0 2/558 (0.36%)  2
Mouth cyst  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Nausea  1  1/557 (0.18%)  1 1/558 (0.18%)  1
Peptic ulcer  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Peritonitis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Upper gastrointestinal haemorrhage  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Vomiting  1  0/557 (0.00%)  0 2/558 (0.36%)  2
General disorders     
Asthenia  1  2/557 (0.36%)  2 1/558 (0.18%)  1
Chest discomfort  1  1/557 (0.18%)  1 1/558 (0.18%)  1
Chest pain  1  4/557 (0.72%)  4 6/558 (1.08%)  6
Cyst  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Hernia obstructive  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Multi-organ failure  1  1/557 (0.18%)  1 2/558 (0.36%)  2
Non-cardiac chest pain  1  2/557 (0.36%)  2 2/558 (0.36%)  2
Oedema peripheral  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Pyrexia  1  3/557 (0.54%)  3 1/558 (0.18%)  1
Hepatobiliary disorders     
Bile duct stone  1  0/557 (0.00%)  0 2/558 (0.36%)  2
Biliary colic  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Cholangitis  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Cholecystitis  1  1/557 (0.18%)  1 1/558 (0.18%)  1
Cholecystitis acute  1  1/557 (0.18%)  1 1/558 (0.18%)  1
Cholelithiasis  1  1/557 (0.18%)  1 3/558 (0.54%)  3
Hepatic cirrhosis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Sarcoidosis  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Infections and infestations     
Abscess limb  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Abscess neck  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Appendicitis  1  2/557 (0.36%)  2 2/558 (0.36%)  2
Arthritis bacterial  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Bronchitis  1  3/557 (0.54%)  3 3/558 (0.54%)  3
Bronchopneumonia  1  0/557 (0.00%)  0 3/558 (0.54%)  3
Campylobacter gastroenteritis  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Cellulitis  1  3/557 (0.54%)  3 3/558 (0.54%)  3
Chronic tonsillitis  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Diverticulitis  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Erysipelas  1  1/557 (0.18%)  1 1/558 (0.18%)  1
Gangrene  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Gastroenteritis  1  1/557 (0.18%)  1 2/558 (0.36%)  2
Intervertebral discitis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Localised infection  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Lower respiratory tract infection  1  1/557 (0.18%)  1 2/558 (0.36%)  2
Mediastinitis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Meningitis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Meningitis aseptic  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Nasopharyngitis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Osteomyelitis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Paronychia  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Perianal abscess  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Pneumonia  1  7/557 (1.26%)  7 4/558 (0.72%)  4
Postoperative wound infection  1  1/557 (0.18%)  1 1/558 (0.18%)  1
Purulent pericarditis  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Pyelonephritis  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Pyelonephritis chronic  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Pyometra  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Respiratory tract infection viral  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Sepsis  1  5/557 (0.90%)  5 0/558 (0.00%)  0
Septic arthritis staphylococcal  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Septic shock  1  2/557 (0.36%)  2 2/558 (0.36%)  2
Streptococcal bacteraemia  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Subcutaneous abscess  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Urinary tract infection  1  5/557 (0.90%)  5 4/558 (0.72%)  4
Wound infection  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Wound sepsis  1  3/557 (0.54%)  3 0/558 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture  1  1/557 (0.18%)  1 1/558 (0.18%)  1
Excoriation  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Femur fracture  1  2/557 (0.36%)  2 0/558 (0.00%)  0
Foot fracture  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Glaucoma traumatic  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Hand fracture  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Head injury  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Soft tissue injury  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Subdural haemorrhage  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Thermal burn  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Traumatic intracranial haemorrhage  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Wound dehiscence  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Investigations     
Blood pressure increased  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Hepatic enzyme increased  1  1/557 (0.18%)  1 0/558 (0.00%)  0
International normalised ratio increased  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Troponin increased  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Metabolism and nutrition disorders     
Diabetes mellitus  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Diabetes mellitus inadequate control  1  4/557 (0.72%)  4 1/558 (0.18%)  1
Diabetic foot  1  3/557 (0.54%)  3 1/558 (0.18%)  1
Gout  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Hyperglycaemia  1  4/557 (0.72%)  4 1/558 (0.18%)  1
Hyperkalaemia  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Hypoglycaemia  1  6/557 (1.08%)  6 7/558 (1.25%)  7
Hypokalaemia  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Insulin resistance  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Fistula  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Intervertebral disc disorder  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Joint swelling  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Musculoskeletal chest pain  1  1/557 (0.18%)  1 1/558 (0.18%)  1
Musculoskeletal pain  1  2/557 (0.36%)  2 0/558 (0.00%)  0
Osteoarthritis  1  2/557 (0.36%)  2 0/558 (0.00%)  0
Rheumatoid arthritis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Spinal column stenosis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Spinal osteoarthritis  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma pancreas  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Basal cell carcinoma  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Bile duct cancer  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Bladder cancer  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Breast cancer  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Choroid melanoma  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Chronic lymphocytic leukaemia  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Colon cancer  1  1/557 (0.18%)  1 1/558 (0.18%)  1
Endometrial cancer  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Gastric cancer  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Lipoma  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Lung neoplasm malignant  1  2/557 (0.36%)  2 0/558 (0.00%)  0
Meningioma  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Pancreatic carcinoma metastatic  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Prostatic adenoma  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Renal cell carcinoma stage II  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Renal cell carcinoma stage unspecified  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Uterine leiomyoma  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Nervous system disorders     
Amnesia  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Carotid artery occlusion  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Carotid artery stenosis  1  2/557 (0.36%)  2 1/558 (0.18%)  1
Cervicobrachial syndrome  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Cluster headache  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Diabetic neuropathy  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Dizziness  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Epilepsy  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Headache  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Hemiparesis  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Hypotonia  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Intercostal neuralgia  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Mononeuropathy multiplex  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Parkinson's disease  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Presyncope  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Psychomotor hyperactivity  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Radiculopathy  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Subarachnoid haemorrhage  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Syncope  1  2/557 (0.36%)  2 7/558 (1.25%)  7
Transient ischaemic attack  1  4/557 (0.72%)  4 0/558 (0.00%)  0
Vertebrobasilar insufficiency  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Psychiatric disorders     
Mood disorder due to a general medical condition  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Post-traumatic stress disorder  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Psychotic disorder due to a general medical condition  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Renal and urinary disorders     
Calculus ureteric  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Diabetic nephropathy  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Haematuria  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Renal artery stenosis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Renal colic  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Renal failure  1  2/557 (0.36%)  2 2/558 (0.36%)  2
Renal failure acute  1  1/557 (0.18%)  1 3/558 (0.54%)  3
Renal failure chronic  1  1/557 (0.18%)  1 2/558 (0.36%)  2
Urethral obstruction  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Urinary retention  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Reproductive system and breast disorders     
Endometrial hyperplasia  1  2/557 (0.36%)  2 0/558 (0.00%)  0
Polycystic ovaries  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Postmenopausal haemorrhage  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Uterine polyp  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Uterine prolapse  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Asthma  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Bronchitis chronic  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Chronic obstructive pulmonary disease  1  0/557 (0.00%)  0 3/558 (0.54%)  3
Dyspnoea  1  1/557 (0.18%)  1 1/558 (0.18%)  1
Epistaxis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Hydrothorax  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Pharyngeal oedema  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Pleural effusion  1  0/557 (0.00%)  0 3/558 (0.54%)  3
Pulmonary congestion  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Pulmonary embolism  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Pulmonary oedema  1  3/557 (0.54%)  3 2/558 (0.36%)  2
Vocal cord polyp  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Skin and subcutaneous tissue disorders     
Angioedema  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Decubitus ulcer  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Erythema  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Hyperhidrosis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Idiopathic urticaria  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Photodermatosis  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Skin ulcer  1  1/557 (0.18%)  1 1/558 (0.18%)  1
Surgical and medical procedures     
Implantable defibrillator insertion  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Toe amputation  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Vascular disorders     
Accelerated hypertension  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Aortic aneurysm  1  1/557 (0.18%)  1 2/558 (0.36%)  2
Arterial stenosis limb  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Arteriosclerosis obliterans  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Deep vein thrombosis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Embolism  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Extremity necrosis  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Hypertension  1  2/557 (0.36%)  2 1/558 (0.18%)  1
Hypertensive crisis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Hypotension  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Peripheral arterial occlusive disease  1  2/557 (0.36%)  2 1/558 (0.18%)  1
Peripheral embolism  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Peripheral ischaemia  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Post thrombotic syndrome  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Shock  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Thrombosis  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Varicose vein  1  0/557 (0.00%)  0 1/558 (0.18%)  1
Venous thrombosis  1  1/557 (0.18%)  1 0/558 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Postprandial Fasting
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   356      346    
Cardiac disorders     
Angina pectoris  1  17/557 (3.05%)  17 22/558 (3.94%)  22
Eye disorders     
Diabetic retinopathy  1  25/557 (4.49%)  25 29/558 (5.20%)  29
General disorders     
Chest pain  1  19/557 (3.41%)  19 17/558 (3.05%)  17
Oedema peripheral  1  28/557 (5.03%)  28 28/558 (5.02%)  28
Infections and infestations     
Bronchitis  1  22/557 (3.95%)  22 23/558 (4.12%)  23
Influenza  1  19/557 (3.41%)  19 29/558 (5.20%)  29
Nasopharyngitis  1  35/557 (6.28%)  35 36/558 (6.45%)  36
Urinary tract infection  1  14/557 (2.51%)  14 19/558 (3.41%)  19
Investigations     
Arteriogram coronary  1  25/557 (4.49%)  25 22/558 (3.94%)  22
Weight increased  1  19/557 (3.41%)  19 16/558 (2.87%)  16
Musculoskeletal and connective tissue disorders     
Arthralgia  1  20/557 (3.59%)  20 23/558 (4.12%)  23
Back pain  1  21/557 (3.77%)  21 28/558 (5.02%)  28
Musculoskeletal pain  1  9/557 (1.62%)  9 19/558 (3.41%)  19
Pain in extremity  1  19/557 (3.41%)  19 25/558 (4.48%)  25
Nervous system disorders     
Diabetic neuropathy  1  23/557 (4.13%)  23 23/558 (4.12%)  23
Headache  1  19/557 (3.41%)  19 18/558 (3.23%)  18
Psychiatric disorders     
Depression  1  20/557 (3.59%)  20 13/558 (2.33%)  13
Respiratory, thoracic and mediastinal disorders     
Cough  1  27/557 (4.85%)  27 23/558 (4.12%)  23
Vascular disorders     
Hypertension  1  30/557 (5.39%)  30 27/558 (4.84%)  27
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
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: 1-800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191282    
Other Study ID Numbers: 5509
F3Z-MC-IONM ( Other Identifier: Eli Lilly and Company )
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: October 17, 2008
Results First Posted: August 4, 2009
Last Update Posted: January 20, 2011