Trial Outcomes & Findings for Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes (NCT NCT00191282)
NCT ID: NCT00191282
Last Updated: 2011-01-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1116 participants
Primary outcome timeframe
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)
Results posted on
2011-01-20
Participant Flow
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.
Participant milestones
| Measure |
Postprandial
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%.
|
Fasting
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 Study
STARTED
|
558
|
558
|
|
Overall Study
COMPLETED
|
338
|
346
|
|
Overall Study
NOT COMPLETED
|
220
|
212
|
Reasons for withdrawal
| Measure |
Postprandial
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%.
|
Fasting
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 Study
Adverse Event
|
5
|
6
|
|
Overall Study
Death
|
51
|
51
|
|
Overall Study
Lack of Efficacy
|
11
|
6
|
|
Overall Study
Noncompliance
|
14
|
17
|
|
Overall Study
Patient moved
|
11
|
14
|
|
Overall Study
Withdrawal by Subject
|
59
|
44
|
|
Overall Study
Physician Decision
|
18
|
15
|
|
Overall Study
Protocol entry criteria not met
|
14
|
9
|
|
Overall Study
Protocol Violation
|
9
|
12
|
|
Overall Study
Severity of outcome
|
2
|
5
|
|
Overall Study
Sponsor's decision
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
24
|
31
|
Baseline Characteristics
Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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
n=1115 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
61.1 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
201 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
409 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
356 Participants
n=5 Participants
|
350 Participants
n=7 Participants
|
706 Participants
n=5 Participants
|
|
Region of Enrollment
Slovakia (Slovak Republic)
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Slovenia
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Lebanon
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
38 participants
n=5 Participants
|
38 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
63 participants
n=5 Participants
|
65 participants
n=7 Participants
|
128 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
India
|
36 participants
n=5 Participants
|
34 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
26 participants
n=5 Participants
|
24 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
41 participants
n=5 Participants
|
41 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
102 participants
n=5 Participants
|
103 participants
n=7 Participants
|
205 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
72 participants
n=5 Participants
|
71 participants
n=7 Participants
|
143 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
33 participants
n=5 Participants
|
31 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
44 participants
n=5 Participants
|
45 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
484 participants
n=5 Participants
|
483 participants
n=7 Participants
|
967 participants
n=5 Participants
|
|
Race/Ethnicity
Western Asian
|
61 participants
n=5 Participants
|
58 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Race/Ethnicity
African Descent
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity
Other
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)Population: All randomized patients who took at least one dose of study drug
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.
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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%.
|
|---|---|---|
|
Number of Participants Who Experienced a Primary Combined Outcome
|
174 participants
|
181 participants
|
SECONDARY outcome
Timeframe: 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)Population: All randomized patients who took at least one dose of study drug.
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.
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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%.
|
|---|---|---|
|
Number of Participants Who Experienced Death From Any Cause or Any One of the Primary Outcomes
|
178 participants
|
189 participants
|
SECONDARY outcome
Timeframe: Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)Population: All randomized patients who took at least one dose of study drug.
Indicators of metabolic control included glycosylated hemoglobin (HbA1c) and fasting blood glucose concentrations.
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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%.
|
|---|---|---|
|
Number of Participants Who Experienced Any One of the Primary Outcomes Adjusted for Indicators of Metabolic Control
|
174 participants
|
181 participants
|
SECONDARY outcome
Timeframe: Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)Population: All randomized patients who took at least one dose of study drug.
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).
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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%.
|
|---|---|---|
|
Number of Participants Who Experienced Primary Outcomes Adjusted for Metabolic Control and Major Cardiovascular (CV) Risk Factors
|
174 participants
|
181 participants
|
SECONDARY outcome
Timeframe: Randomization (Day 0) until death from any cause (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)Population: All randomized patients who took at least one dose of study drug.
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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%.
|
|---|---|---|
|
Number of Participants Who Experienced Death From Any Cause
|
51 participants
|
51 participants
|
SECONDARY outcome
Timeframe: Randomization (Day 0) until cardiovascular death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)Population: All randomized patients who took at least one dose of study drug.
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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%.
|
|---|---|---|
|
Number of Participants Who Experienced Cardiovascular (CV) Death
|
44 participants
|
42 participants
|
SECONDARY outcome
Timeframe: Randomization (Day 0) until myocardial infarction (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)Population: All randomized patients who took at least one dose of study drug.
Occurrence of myocardial infarction (MI) (fatal, nonfatal, any).
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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%.
|
|---|---|---|
|
Number of Participants Who Experienced Myocardial Infarction (MI)
|
63 participants
|
63 participants
|
SECONDARY outcome
Timeframe: Randomization (Day 0) until stroke (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)Population: All randomized patients who took at least one dose of study drug.
Occurrence of stroke (fatal, nonfatal, any).
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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%.
|
|---|---|---|
|
Number of Participants Who Experienced Stroke
|
20 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Randomization (Day 0) until HACS (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)Population: All randomized patients who took at least one dose of study drug.
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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%.
|
|---|---|---|
|
Number of Participants Who Experienced Hospitalization for Acute Coronary Syndromes (HACS)
|
58 participants
|
54 participants
|
SECONDARY outcome
Timeframe: Randomization (Day 0) until coronary revascularization procedures (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)Population: All randomized patients who took at least one dose of study drug.
Occurrence of all coronary revascularization procedures (angioplasty or coronary artery by-pass surgery) planned after randomization.
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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%.
|
|---|---|---|
|
Number of Participants Who Experienced Coronary Revascularization Procedures
|
84 participants
|
94 participants
|
SECONDARY outcome
Timeframe: Randomization (Day 0) until amputation (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)Population: All randomized patients who took at least one dose of study drug.
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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%.
|
|---|---|---|
|
Number of Participants Who Experienced Amputation for Peripheral Vascular Disease Planned After Randomization
|
9 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Randomization (Day 0) until congestive heart failure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)Population: All randomized patients who took at least one dose of study drug.
Occurrence of congestive heart failure (newly diagnosed after Visit 2).
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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%.
|
|---|---|---|
|
Number of Participants Who Experienced Congestive Heart Failure
|
33 participants
|
37 participants
|
SECONDARY outcome
Timeframe: Randomization (Day 0) until revascularization procedure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)Population: All randomized patients who took at least one dose of study drug.
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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%.
|
|---|---|---|
|
Number of Participants Who Experienced Revascularization Procedure for Peripheral Vascular Disease Planned After Randomization
|
11 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Randomization (Day 0) until coronary angiography (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)Population: All randomized patients who took at least one dose of study drug.
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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%.
|
|---|---|---|
|
Number of Participants Who Experienced Coronary Angiography Planned After Randomization
|
75 participants
|
86 participants
|
SECONDARY outcome
Timeframe: Visit 3 (Month 1)Population: All randomized patients who took at least one dose of study drug.
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).
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=557 Participants
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%.
|
|---|---|---|
|
Number of Participants With Self-Reported Hypoglycemia During Month 1
|
124 participants
|
119 participants
|
SECONDARY outcome
Timeframe: Visit 3 (Month 1)Population: All randomized participants who self-reported hypoglycemia during Month 1.
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).
Outcome measures
| Measure |
Postprandial
n=124 Participants
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%.
|
Fasting
n=119 Participants
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%.
|
|---|---|---|
|
Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 1
|
353 episodes of hypoglycemia
|
302 episodes of hypoglycemia
|
SECONDARY outcome
Timeframe: Visit 4 (Month 3)Population: All randomized patients who took at least one dose of study drug and who were still in the study.
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).
Outcome measures
| Measure |
Postprandial
n=511 Participants
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%.
|
Fasting
n=525 Participants
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%.
|
|---|---|---|
|
Number of Participants With Self-Reported Hypoglycemia During Month 3
|
160 participants
|
139 participants
|
SECONDARY outcome
Timeframe: Visit 4 (Month 3)Population: All randomized participants who self-reported hypoglycemia during Month 3.
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).
Outcome measures
| Measure |
Postprandial
n=160 Participants
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%.
|
Fasting
n=139 Participants
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%.
|
|---|---|---|
|
Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 3
|
567 episodes of hypoglycemia
|
524 episodes of hypoglycemia
|
SECONDARY outcome
Timeframe: Visit 5 (Month 6)Population: All randomized patients who took at least one dose of study drug and who were still in the study.
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).
Outcome measures
| Measure |
Postprandial
n=493 Participants
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%.
|
Fasting
n=504 Participants
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%.
|
|---|---|---|
|
Number of Participants With Self-Reported Hypoglycemia During Month 6
|
163 participants
|
145 participants
|
SECONDARY outcome
Timeframe: Visit 5 (Month 6)Population: All randomized participants with self-reported hypoglycemia during Month 6.
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).
Outcome measures
| Measure |
Postprandial
n=163 Participants
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%.
|
Fasting
n=145 Participants
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%.
|
|---|---|---|
|
Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 6
|
770 episodes of hypoglycemia
|
576 episodes of hypoglycemia
|
SECONDARY outcome
Timeframe: Visit 6 (Month 9)Population: All randomized patients who took at least one dose of study drug and who were still in the study.
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).
Outcome measures
| Measure |
Postprandial
n=483 Participants
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%.
|
Fasting
n=488 Participants
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%.
|
|---|---|---|
|
Number of Participants With Self-Reported Hypoglycemia During Month 9
|
155 participants
|
138 participants
|
SECONDARY outcome
Timeframe: Visit 6 (Month 9)Population: All randomized participants with self-reported hypoglycemia during Month 9.
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).
Outcome measures
| Measure |
Postprandial
n=155 Participants
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%.
|
Fasting
n=138 Participants
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%.
|
|---|---|---|
|
Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 9
Number of Episodes
|
747 episodes of hypoglycemia
|
569 episodes of hypoglycemia
|
SECONDARY outcome
Timeframe: Visit 7 (Month 12)Population: All randomized patients who took at least one dose of study drug and who were still in the study.
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).
Outcome measures
| Measure |
Postprandial
n=470 Participants
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%.
|
Fasting
n=471 Participants
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%.
|
|---|---|---|
|
Number of Participants With Self-Reported Hypoglycemia During Month 12
|
146 participants
|
130 participants
|
SECONDARY outcome
Timeframe: Visit 7 (Month 12)Population: All randomized participants with self-reported hypoglycemia during Month 12.
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).
Outcome measures
| Measure |
Postprandial
n=146 Participants
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%.
|
Fasting
n=130 Participants
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%.
|
|---|---|---|
|
Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 12
|
710 episodes of hypoglycemia
|
486 episodes of hypoglycemia
|
SECONDARY outcome
Timeframe: Visit 8 (Month 18)Population: All randomized patients who took at least one dose of study drug and who were still in the study.
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).
Outcome measures
| Measure |
Postprandial
n=452 Participants
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%.
|
Fasting
n=457 Participants
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%.
|
|---|---|---|
|
Number of Participants With Self-Reported Hypoglycemia During Month 18
|
143 participants
|
129 participants
|
SECONDARY outcome
Timeframe: Visit 8 (Month 18)Population: All randomized participants with self-reported hypoglycemia during Month 18.
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).
Outcome measures
| Measure |
Postprandial
n=143 Participants
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%.
|
Fasting
n=129 Participants
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%.
|
|---|---|---|
|
Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 18
|
945 episodes of hypoglycemia
|
669 episodes of hypoglycemia
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization (Day 0) to death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)Population: All randomized patients who took at least one dose of study drug.
Outcome measures
| Measure |
Postprandial
n=557 Participants
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%.
|
Fasting
n=558 Participants
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%.
|
|---|---|---|
|
Summary of Reasons for Deaths
Fatal MI
|
12 participants
|
12 participants
|
|
Summary of Reasons for Deaths
Fatal Stroke
|
3 participants
|
2 participants
|
|
Summary of Reasons for Deaths
CV Death other than Stroke/MI
|
29 participants
|
28 participants
|
|
Summary of Reasons for Deaths
Non-CV Death
|
7 participants
|
8 participants
|
|
Summary of Reasons for Deaths
Unknown
|
0 participants
|
1 participants
|
Adverse Events
Postprandial
Serious events: 145 serious events
Other events: 356 other events
Deaths: 0 deaths
Fasting
Serious events: 142 serious events
Other events: 346 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Postprandial
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%.
|
Fasting
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%.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.18%
1/557 • Number of events 1
|
0.18%
1/558 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Cardiac disorders
Acute left ventricular failure
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/557
|
0.36%
2/558 • Number of events 2
|
|
Cardiac disorders
Angina pectoris
|
0.54%
3/557 • Number of events 3
|
0.54%
3/558 • Number of events 3
|
|
Cardiac disorders
Angina unstable
|
0.36%
2/557 • Number of events 2
|
0.18%
1/558 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.36%
2/557 • Number of events 2
|
1.3%
7/558 • Number of events 7
|
|
Cardiac disorders
Atrial flutter
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Cardiac disorders
Cardiac failure
|
0.36%
2/557 • Number of events 2
|
0.18%
1/558 • Number of events 1
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/557
|
0.36%
2/558 • Number of events 2
|
|
Cardiac disorders
Cardiac failure congestive
|
1.4%
8/557 • Number of events 8
|
1.4%
8/558 • Number of events 8
|
|
Cardiac disorders
Conduction disorder
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Cardiac disorders
Coronary artery restenosis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Cardiac disorders
Dressler's syndrome
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Cardiac disorders
Mitral valve incompetence
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Cardiac disorders
Myocardial infarction
|
0.18%
1/557 • Number of events 1
|
0.36%
2/558 • Number of events 2
|
|
Cardiac disorders
Sick sinus syndrome
|
0.36%
2/557 • Number of events 2
|
0.36%
2/558 • Number of events 2
|
|
Cardiac disorders
Sinus bradycardia
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
0.36%
2/557 • Number of events 2
|
0.18%
1/558 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.36%
2/557 • Number of events 2
|
0.00%
0/558
|
|
Ear and labyrinth disorders
Vestibular neuronitis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Endocrine disorders
Hyperthyroidism
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Eye disorders
Cataract
|
0.54%
3/557 • Number of events 3
|
0.18%
1/558 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Eye disorders
Diabetic retinopathy
|
0.36%
2/557 • Number of events 2
|
0.18%
1/558 • Number of events 1
|
|
Eye disorders
Glaucoma
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Eye disorders
Vitreous haemorrhage
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Gastrointestinal disorders
Abdominal pain
|
0.36%
2/557 • Number of events 2
|
0.36%
2/558 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.18%
1/557 • Number of events 1
|
0.36%
2/558 • Number of events 2
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Gastrointestinal disorders
Colonic polyp
|
0.18%
1/557 • Number of events 1
|
0.18%
1/558 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.18%
1/557 • Number of events 1
|
0.18%
1/558 • Number of events 1
|
|
Gastrointestinal disorders
Duodenitis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Gastrointestinal disorders
Enteritis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Gastrointestinal disorders
Gastritis
|
0.54%
3/557 • Number of events 3
|
0.36%
2/558 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.36%
2/557 • Number of events 2
|
0.00%
0/558
|
|
Gastrointestinal disorders
Gastrointestinal telangiectasia
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/557
|
0.36%
2/558 • Number of events 2
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.18%
1/557 • Number of events 1
|
0.18%
1/558 • Number of events 1
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.18%
1/557 • Number of events 1
|
0.36%
2/558 • Number of events 2
|
|
Gastrointestinal disorders
Ileus
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.36%
2/557 • Number of events 2
|
0.00%
0/558
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/557
|
0.36%
2/558 • Number of events 2
|
|
Gastrointestinal disorders
Mouth cyst
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.18%
1/557 • Number of events 1
|
0.18%
1/558 • Number of events 1
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Gastrointestinal disorders
Peritonitis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/557
|
0.36%
2/558 • Number of events 2
|
|
General disorders
Asthenia
|
0.36%
2/557 • Number of events 2
|
0.18%
1/558 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.18%
1/557 • Number of events 1
|
0.18%
1/558 • Number of events 1
|
|
General disorders
Chest pain
|
0.72%
4/557 • Number of events 4
|
1.1%
6/558 • Number of events 6
|
|
General disorders
Cyst
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
General disorders
Hernia obstructive
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
General disorders
Multi-organ failure
|
0.18%
1/557 • Number of events 1
|
0.36%
2/558 • Number of events 2
|
|
General disorders
Non-cardiac chest pain
|
0.36%
2/557 • Number of events 2
|
0.36%
2/558 • Number of events 2
|
|
General disorders
Oedema peripheral
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
General disorders
Pyrexia
|
0.54%
3/557 • Number of events 3
|
0.18%
1/558 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/557
|
0.36%
2/558 • Number of events 2
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.18%
1/557 • Number of events 1
|
0.18%
1/558 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.18%
1/557 • Number of events 1
|
0.18%
1/558 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.18%
1/557 • Number of events 1
|
0.54%
3/558 • Number of events 3
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Immune system disorders
Hypersensitivity
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Abscess limb
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Abscess neck
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.36%
2/557 • Number of events 2
|
0.36%
2/558 • Number of events 2
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.54%
3/557 • Number of events 3
|
0.54%
3/558 • Number of events 3
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/557
|
0.54%
3/558 • Number of events 3
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.54%
3/557 • Number of events 3
|
0.54%
3/558 • Number of events 3
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Erysipelas
|
0.18%
1/557 • Number of events 1
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Gangrene
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Infections and infestations
Gastroenteritis
|
0.18%
1/557 • Number of events 1
|
0.36%
2/558 • Number of events 2
|
|
Infections and infestations
Intervertebral discitis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Infections and infestations
Localised infection
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Infections and infestations
Lower respiratory tract infection
|
0.18%
1/557 • Number of events 1
|
0.36%
2/558 • Number of events 2
|
|
Infections and infestations
Mediastinitis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Infections and infestations
Meningitis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Infections and infestations
Meningitis aseptic
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Infections and infestations
Nasopharyngitis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Infections and infestations
Osteomyelitis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Infections and infestations
Paronychia
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Perianal abscess
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.3%
7/557 • Number of events 7
|
0.72%
4/558 • Number of events 4
|
|
Infections and infestations
Postoperative wound infection
|
0.18%
1/557 • Number of events 1
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Purulent pericarditis
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Pyometra
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.90%
5/557 • Number of events 5
|
0.00%
0/558
|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Septic shock
|
0.36%
2/557 • Number of events 2
|
0.36%
2/558 • Number of events 2
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.90%
5/557 • Number of events 5
|
0.72%
4/558 • Number of events 4
|
|
Infections and infestations
Wound infection
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Infections and infestations
Wound sepsis
|
0.54%
3/557 • Number of events 3
|
0.00%
0/558
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.18%
1/557 • Number of events 1
|
0.18%
1/558 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.36%
2/557 • Number of events 2
|
0.00%
0/558
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Injury, poisoning and procedural complications
Glaucoma traumatic
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Investigations
Blood pressure increased
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Investigations
Hepatic enzyme increased
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Investigations
International normalised ratio increased
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Investigations
Troponin increased
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.72%
4/557 • Number of events 4
|
0.18%
1/558 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.54%
3/557 • Number of events 3
|
0.18%
1/558 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.72%
4/557 • Number of events 4
|
0.18%
1/558 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
6/557 • Number of events 6
|
1.3%
7/558 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.18%
1/557 • Number of events 1
|
0.18%
1/558 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.36%
2/557 • Number of events 2
|
0.00%
0/558
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.36%
2/557 • Number of events 2
|
0.00%
0/558
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.18%
1/557 • Number of events 1
|
0.18%
1/558 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.36%
2/557 • Number of events 2
|
0.00%
0/558
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage II
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Nervous system disorders
Amnesia
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Nervous system disorders
Carotid artery occlusion
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Nervous system disorders
Carotid artery stenosis
|
0.36%
2/557 • Number of events 2
|
0.18%
1/558 • Number of events 1
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Nervous system disorders
Cluster headache
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Nervous system disorders
Intercostal neuralgia
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Nervous system disorders
Mononeuropathy multiplex
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Nervous system disorders
Parkinson's disease
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Nervous system disorders
Presyncope
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.36%
2/557 • Number of events 2
|
1.3%
7/558 • Number of events 7
|
|
Nervous system disorders
Transient ischaemic attack
|
0.72%
4/557 • Number of events 4
|
0.00%
0/558
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Psychiatric disorders
Mood disorder due to a general medical condition
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Psychiatric disorders
Psychotic disorder due to a general medical condition
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.36%
2/557 • Number of events 2
|
0.36%
2/558 • Number of events 2
|
|
Renal and urinary disorders
Renal failure acute
|
0.18%
1/557 • Number of events 1
|
0.54%
3/558 • Number of events 3
|
|
Renal and urinary disorders
Renal failure chronic
|
0.18%
1/557 • Number of events 1
|
0.36%
2/558 • Number of events 2
|
|
Renal and urinary disorders
Urethral obstruction
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.36%
2/557 • Number of events 2
|
0.00%
0/558
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/557
|
0.54%
3/558 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.18%
1/557 • Number of events 1
|
0.18%
1/558 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/557
|
0.54%
3/558 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.54%
3/557 • Number of events 3
|
0.36%
2/558 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Skin and subcutaneous tissue disorders
Idiopathic urticaria
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Photodermatosis
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.18%
1/557 • Number of events 1
|
0.18%
1/558 • Number of events 1
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Surgical and medical procedures
Toe amputation
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Vascular disorders
Accelerated hypertension
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Vascular disorders
Aortic aneurysm
|
0.18%
1/557 • Number of events 1
|
0.36%
2/558 • Number of events 2
|
|
Vascular disorders
Arterial stenosis limb
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Vascular disorders
Deep vein thrombosis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Vascular disorders
Embolism
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.36%
2/557 • Number of events 2
|
0.18%
1/558 • Number of events 1
|
|
Vascular disorders
Hypertensive crisis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Vascular disorders
Hypotension
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.36%
2/557 • Number of events 2
|
0.18%
1/558 • Number of events 1
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Vascular disorders
Peripheral ischaemia
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Vascular disorders
Post thrombotic syndrome
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Vascular disorders
Shock
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
|
Vascular disorders
Thrombosis
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Vascular disorders
Varicose vein
|
0.00%
0/557
|
0.18%
1/558 • Number of events 1
|
|
Vascular disorders
Venous thrombosis
|
0.18%
1/557 • Number of events 1
|
0.00%
0/558
|
Other adverse events
| Measure |
Postprandial
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%.
|
Fasting
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%.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
3.1%
17/557 • Number of events 17
|
3.9%
22/558 • Number of events 22
|
|
Eye disorders
Diabetic retinopathy
|
4.5%
25/557 • Number of events 25
|
5.2%
29/558 • Number of events 29
|
|
General disorders
Chest pain
|
3.4%
19/557 • Number of events 19
|
3.0%
17/558 • Number of events 17
|
|
General disorders
Oedema peripheral
|
5.0%
28/557 • Number of events 28
|
5.0%
28/558 • Number of events 28
|
|
Infections and infestations
Bronchitis
|
3.9%
22/557 • Number of events 22
|
4.1%
23/558 • Number of events 23
|
|
Infections and infestations
Influenza
|
3.4%
19/557 • Number of events 19
|
5.2%
29/558 • Number of events 29
|
|
Infections and infestations
Nasopharyngitis
|
6.3%
35/557 • Number of events 35
|
6.5%
36/558 • Number of events 36
|
|
Infections and infestations
Urinary tract infection
|
2.5%
14/557 • Number of events 14
|
3.4%
19/558 • Number of events 19
|
|
Investigations
Arteriogram coronary
|
4.5%
25/557 • Number of events 25
|
3.9%
22/558 • Number of events 22
|
|
Investigations
Weight increased
|
3.4%
19/557 • Number of events 19
|
2.9%
16/558 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
20/557 • Number of events 20
|
4.1%
23/558 • Number of events 23
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
21/557 • Number of events 21
|
5.0%
28/558 • Number of events 28
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.6%
9/557 • Number of events 9
|
3.4%
19/558 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
19/557 • Number of events 19
|
4.5%
25/558 • Number of events 25
|
|
Nervous system disorders
Diabetic neuropathy
|
4.1%
23/557 • Number of events 23
|
4.1%
23/558 • Number of events 23
|
|
Nervous system disorders
Headache
|
3.4%
19/557 • Number of events 19
|
3.2%
18/558 • Number of events 18
|
|
Psychiatric disorders
Depression
|
3.6%
20/557 • Number of events 20
|
2.3%
13/558 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
27/557 • Number of events 27
|
4.1%
23/558 • Number of events 23
|
|
Vascular disorders
Hypertension
|
5.4%
30/557 • Number of events 30
|
4.8%
27/558 • Number of events 27
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60