Comparison Study of Insulin Glargine and NPH Insulin
Withdrawn before enrolling · Phase 4
Conditions studied: Diabetes
In brief
This study will compare the safety, effectiveness, and cost of two different types of long-acting insulin.
Key facts
- Study ID
- NCT01854723
- Run by
- Providence Health & Services
- People needed
- 0
- Starts
- 2013-04-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2020-03-10
Who can join
Age: any, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Providence Medical Group Northeast Clinic — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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