Comparison Study of Insulin Glargine and NPH Insulin

• Status: Withdrawn
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the safety, effectiveness, and cost of two different types of long-acting insulin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Providence Health & Services
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

• Adult patients at 22 Providence Medical Group primary care clinics

• Diagnosis of type 2 diabetes mellitus

• Currently using greater than 80 units/day of insulin glargine or greater than 1 unit/kg/day of insulin glargine

• Current A1C > 8.5% (within 3 months of randomization)

Exclusion Criteria:

• Diagnosis of type 1 diabetes mellitus

• Age > 85 years

• Self-reported history of severe hypoglycemia or hypoglycemia unawareness

• Hospice/limited life expectancy

• Current enrollment in Providence Medical Group Medication Assistance Program

• Current use of a GLP1 agonist (i.e., liraglutide, exenatide, exenatide extended-release)

• End stage renal disease (i.e., dialysis or estimated glomerular filtration rate <15 ml/min/1.73m2)

• Cirrhosis

• Unstable coronary artery disease or chronic heart failure (i.e. an exacerbation or hospitalization within 6 months pre-randomization)

• Psychiatric condition that prevents adequate follow-up (i.e., > 3 missed follow-up visits within a 3 month period or persistent non-adherence to dosing or monitoring recommendations)

• Active alcohol or drug abuse

• Inability to provide informed consent