Status:
WITHDRAWN
Comparison Study of Insulin Glargine and NPH Insulin
Lead Sponsor:
Providence Health & Services
Conditions:
Diabetes
Eligibility:
All Genders
Up to 85 years
Phase:
PHASE4
Brief Summary
This study will compare the safety, effectiveness, and cost of two different types of long-acting insulin.
Detailed Description
In this study the investigators will be comparing two long-acting insulins, insulin glargine and NPH insulin. The trial will be evaluating differences in effectiveness, safety and cost between the two...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01854723
Start Date
April 1 2013
End Date
December 1 2015
Last Update
March 10 2020
Active Locations (1)
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1
Providence Medical Group Northeast Clinic
Portland, Oregon, United States, 97213