Comparison Study of Insulin Glargine and NPH Insulin

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

Detailed Description
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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 agents when used in patients on more than 80 units or 1unit/kg long-acting insulin. The investigators hypothesis is that patients switched from lantus to NPH will have improved blood glucose control.

Official Title
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Basal Insulin Therapy in Patients With Insulin Resistance: A 6 Month Comparison of Insulin Glargine and NPH Insulin

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Switching to NPH insulin
* Drug: Continuation of insulin glargine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Switching to NPH insulin<br>Patients in this arm will be transitioned from insulin glargine to NPH insulin with subsequent titration according to algorithm within protocol. If needed, meal-time insulin will be added during study period. | Drug: Switching to NPH insulin<br>* Patients in this arm will be transitioned from insulin glargine to NPH insulin with subsequent titration according to algorithm within protocol. If needed, meal-time insulin will be added during study period.<br>* Other names: Isophane insulin;|
| Active Comparator: Continuation of insulin glargine<br>Patients in this arm will continue on insulin glargine and serve as a control group. | Drug: Continuation of insulin glargine<br>* Patients in this group will serve as a control group, and information will be collected regarding the safety, effectiveness, and cost of treatment for use in this study.<br>* Other names: Lantus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in A1C between groups at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in A1C between groups at 3 months |  | 3 months | 
| Difference in self-monitored blood glucose averages between groups | Outside of A1C, the investigators will also be comparing self-monitored blood glucose averages within each group and comparing them to one another. | 6 months | 
| Difference in incidence of hypoglycemia between each group | Mild = symptoms consistent with hypoglycemia during which the subject was able to self-treat and was associated with blood glucose < 70mg/dL Severe = symptoms consistent with hypoglycemia during which the subject required the assistance of another person and was associated with either a glucose level < 56 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon Nocturnal hypoglycemia = hypoglycemia as described above occurring after the subject goes to bed and before the measurement of glucose, eating breakfast, or administration of any glucose-lowering agent in the morning | 6 months | 
| Difference in units of basal insulin used per day between groups |  | 6 months | 
| Difference in total units of insulin per day between groups |  | 6 months | 
| Difference in percent of patients who require initiation/titration of prandial insulin between each group |  | 6 months | 
| Difference in rate of mortality in each group during study period |  | 6 months | 
| Difference in morbidity between each group during study period | Morbidity defined as glycemia-related hospitalizations, ER visits, immediate care clinic visits (hypoglycemia, hyperglycemia, diabetic ketoacidosis, hyperosmolar hyperglycemic nonketotic syndrome, hospitalizations diagnosed as related to diabetes with diagnosis code) | 6 months | 
| Compare cost of insulin therapy over study period at study completion | Costs will be calculated as direct patient cost and total cost of medication. | 6 months | 
| Differences in change in weight during study period between groups | Weight change in each patient will be calculated using weight at study initiation and completion | 6 months | 
| Difference in number of visits with clinical pharmacist |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Insulin glargine, NPH insulin