Phase 4
N=1,116
Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes
Diabetes Mellitus, Type 2 · Acute Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00191282 ↗Enrolled (actual)
1,116
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Number of Participants Who Experienced a Primary Combined Outcome — 174; 181 participants — p=0.866
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin lispro (Drug); Human insulin isophane suspension (NPH) (Drug); Insulin glargine (Drug); Human insulin isophane suspension (Drug); Human insulin 30/70 (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced a Primary Combined Outcome |
174; 181 | 0.866 |
| SECONDARY Number of Participants Who Experienced Death From Any Cause or Any One of the Primary Outcomes |
178; 189 | 0.715 |
| SECONDARY Number of Participants Who Experienced Any One of the Primary Outcomes Adjusted for Indicators of Metabolic Control |
174; 181 | 0.914 |
| SECONDARY Number of Participants Who Experienced Primary Outcomes Adjusted for Metabolic Control and Major Cardiovascular (CV) Risk Factors |
174; 181 | 0.706 |
| SECONDARY Number of Participants Who Experienced Death From Any Cause |
51; 51 | 0.982 |
| SECONDARY Number of Participants Who Experienced Cardiovascular (CV) Death |
44; 42 | 0.816 |
| SECONDARY Number of Participants Who Experienced Myocardial Infarction (MI) |
63; 63 | 0.948 |
| SECONDARY Number of Participants Who Experienced Stroke |
20; 17 | 0.581 |
| SECONDARY Number of Participants Who Experienced Hospitalization for Acute Coronary Syndromes (HACS) |
58; 54 | 0.647 |
| SECONDARY Number of Participants Who Experienced Coronary Revascularization Procedures |
84; 94 | 0.525 |
| SECONDARY Number of Participants Who Experienced Amputation for Peripheral Vascular Disease Planned After Randomization |
9; 8 | 0.800 |
| SECONDARY Number of Participants Who Experienced Congestive Heart Failure |
33; 37 | 0.662 |
| SECONDARY Number of Participants Who Experienced Revascularization Procedure for Peripheral Vascular Disease Planned After Randomization |
11; 12 | 0.863 |
| SECONDARY Number of Participants Who Experienced Coronary Angiography Planned After Randomization |
75; 86 | 0.471 |
| SECONDARY Number of Participants With Self-Reported Hypoglycemia During Month 1 |
124; 119 | 0.7168 |
| SECONDARY Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 1 |
353; 302 | — |
| SECONDARY Number of Participants With Self-Reported Hypoglycemia During Month 3 |
160; 139 | 0.0860 |
| SECONDARY Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 3 |
567; 524 | — |
| SECONDARY Number of Participants With Self-Reported Hypoglycemia During Month 6 |
163; 145 | 0.1424 |
| SECONDARY Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 6 |
770; 576 | — |
| SECONDARY Number of Participants With Self-Reported Hypoglycemia During Month 9 |
155; 138 | 0.1957 |
| SECONDARY Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 9 |
747; 569 | — |
| SECONDARY Number of Participants With Self-Reported Hypoglycemia During Month 12 |
146; 130 | 0.2434 |
| SECONDARY Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 12 |
710; 486 | — |
| SECONDARY Number of Participants With Self-Reported Hypoglycemia During Month 18 |
143; 129 | 0.2617 |
| SECONDARY Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 18 |
945; 669 | — |
Summary
The primary objective was to demonstrate a difference between two insulin strategies, one targeting postprandial (PP) hyperglycemia and the other targeting fasting and interprandial hyperglycemia, on time until the first combined adjudicated cardiovascular (CV) event (primary outcome defined as CV death, nonfatal myocardial infarction [MI], nonfatal stroke, coronary revascularization, or hospitalized acute coronary syndrome).
Eligibility Criteria
Inclusion Criteria
- Are at least 30 years old
- Have had type 2 diabetes for at least 3 months prior to Visit 1
- Were admitted to the Coronary Care Unit (CCU) within 18 days prior to Visit 1 for an acute MI
- Are capable and willing to do specified study procedures
- Have given informed consent to participate in the study in accordance with local regulations
Exclusion Criteria
- Were on one of the following therapies prior to admission to the CCU for the recent MI: a)diet therapy only and have glycosylated hemoglobin (HbA1c) <1.15 times the upper limit of normal or b) an intensive basal/bolus insulin regimen
- Are using any oral antihyperglycemic medication at the time of Visit 2 and are unwilling to stop the use of such medication for the duration of the study
- Have substantial myocardial damage, which would significantly outweigh the potential benefit of the treatment strategies for diabetes
- Have the most severe form of congestive heart failure
- Have liver disease so severe that it precludes the patient from following and completing the protocol
Data sourced from ClinicalTrials.gov (NCT00191282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.