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Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes

NCT00191282 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1116

Last updated 2011-01-20

Study results available
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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).

Conditions

  • Diabetes Mellitus, Type 2
  • Acute Myocardial Infarction

Interventions

DRUG

Insulin lispro

Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study

DRUG

Human insulin isophane suspension (NPH)

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%

DRUG

Insulin glargine

Insulin glargine injected subcutaneous (SC) once daily in the evening until patient completes study.

DRUG

Human insulin isophane suspension

Patient adjusted dose, twice daily, injected subcutaneous (SC) before morning and evening meals until patient completes study.

DRUG

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%.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • Canada
  • Croatia
  • Czechia
  • Germany
  • Hungary
  • India
  • Israel
  • Lebanon
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00191282 on ClinicalTrials.gov