Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes (IONM)

• Number of Participants Who Experienced a Primary Combined Outcome [ 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) ] [ Designated as safety issue: Yes ]
  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.
  
  

• Number of Participants Who Experienced Death From Any Cause or Any One of the Primary Outcomes [ 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) ] [ Designated as safety issue: Yes ]
  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.
  
  
• Number of Participants Who Experienced Any One of the Primary Outcomes Adjusted for Indicators of Metabolic Control [ 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) ] [ Designated as safety issue: Yes ]
  Indicators of metabolic control included glycosylated hemoglobin (HbA1c) and fasting blood glucose concentrations.
  
  
• Number of Participants Who Experienced Primary Outcomes Adjusted for Metabolic Control and Major Cardiovascular (CV) Risk Factors [ 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) ] [ Designated as safety issue: Yes ]
  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).
  
  
• Number of Participants Who Experienced Death From Any Cause [ 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) ] [ Designated as safety issue: Yes ]
  
• Number of Participants Who Experienced Cardiovascular (CV) Death [ Time Frame: Randomization (Day 0) until cardiovascular death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years) ] [ Designated as safety issue: Yes ]
  
• Number of Participants Who Experienced Myocardial Infarction (MI) [ Time Frame: Randomization (Day 0) until myocardial infarction (18 month initial treatment period, extended treatment follow-up period up to 5.5 years) ] [ Designated as safety issue: Yes ]
  Occurrence of myocardial infarction (MI) (fatal, nonfatal, any).
  
  
• Number of Participants Who Experienced Stroke [ Time Frame: Randomization (Day 0) until stroke (18 month initial treatment period, extended treatment follow-up period up to 5.5 years) ] [ Designated as safety issue: Yes ]
  Occurrence of stroke (fatal, nonfatal, any).
  
  
• Number of Participants Who Experienced Hospitalization for Acute Coronary Syndromes (HACS) [ Time Frame: Randomization (Day 0) until HACS (18 month initial treatment period, extended treatment follow-up period up to 5.5 years) ] [ Designated as safety issue: Yes ]
  
• Number of Participants Who Experienced Coronary Revascularization Procedures [ Time Frame: Randomization (Day 0) until coronary revascularization procedures (18 month initial treatment period, extended treatment follow-up period up to 5.5 years) ] [ Designated as safety issue: Yes ]
  Occurrence of all coronary revascularization procedures (angioplasty or coronary artery by-pass surgery) planned after randomization.
  
  
• Number of Participants Who Experienced Amputation for Peripheral Vascular Disease Planned After Randomization [ Time Frame: Randomization (Day 0) until amputation (18 month initial treatment period, extended treatment follow-up period up to 5.5 years) ] [ Designated as safety issue: Yes ]
  
• Number of Participants Who Experienced Congestive Heart Failure [ Time Frame: Randomization (Day 0) until congestive heart failure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years) ] [ Designated as safety issue: Yes ]
  Occurrence of congestive heart failure (newly diagnosed after Visit 2).
  
  
• Number of Participants Who Experienced Revascularization Procedure for Peripheral Vascular Disease Planned After Randomization [ Time Frame: Randomization (Day 0) until revascularization procedure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years) ] [ Designated as safety issue: Yes ]
  
• Number of Participants Who Experienced Coronary Angiography Planned After Randomization [ Time Frame: Randomization (Day 0) until coronary angiography (18 month initial treatment period, extended treatment follow-up period up to 5.5 years) ] [ Designated as safety issue: Yes ]
  
• Number of Participants With Self-Reported Hypoglycemia During Month 1 [ Time Frame: Visit 3 (Month 1) ] [ Designated as safety issue: Yes ]
  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).
  
  
• Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 1 [ Time Frame: Visit 3 (Month 1) ] [ Designated as safety issue: Yes ]
  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).
  
  
• Number of Participants With Self-Reported Hypoglycemia During Month 3 [ Time Frame: Visit 4 (Month 3) ] [ Designated as safety issue: Yes ]
  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).
  
  
• Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 3 [ Time Frame: Visit 4 (Month 3) ] [ Designated as safety issue: Yes ]
  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).
  
  
• Number of Participants With Self-Reported Hypoglycemia During Month 6 [ Time Frame: Visit 5 (Month 6) ] [ Designated as safety issue: Yes ]
  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).
  
  
• Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 6 [ Time Frame: Visit 5 (Month 6) ] [ Designated as safety issue: Yes ]
  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).
  
  
• Number of Participants With Self-Reported Hypoglycemia During Month 9 [ Time Frame: Visit 6 (Month 9) ] [ Designated as safety issue: Yes ]
  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).
  
  
• Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 9 [ Time Frame: Visit 6 (Month 9) ] [ Designated as safety issue: Yes ]
  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).
  
  
• Number of Participants With Self-Reported Hypoglycemia During Month 12 [ Time Frame: Visit 7 (Month 12) ] [ Designated as safety issue: Yes ]
  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).
  
  
• Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 12 [ Time Frame: Visit 7 (Month 12) ] [ Designated as safety issue: Yes ]
  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).
  
  
• Number of Participants With Self-Reported Hypoglycemia During Month 18 [ Time Frame: Visit 8 (Month 18) ] [ Designated as safety issue: Yes ]
  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).
  
  
• Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 18 [ Time Frame: Visit 8 (Month 18) ] [ Designated as safety issue: Yes ]
  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).
  
  

The purpose of this study is to evaluate the effect of two different treatment strategies on CV outcomes in patients with type 2 diabetes while aiming to achieve and maintain HbA1c <7.0% in both groups. Only patients who have recently experienced an acute MI will be considered for participation in this trial.