Comparison Study of Insulin Glargine and NPH Insulin

Phase 4

Withdrawn

• Conditions: Diabetes
• Interventions: Drug: Switching to NPH insulin; Drug: Continuation of insulin glargine

• Registration Number: NCT01854723
• Lead Sponsor: Providence Health & Services

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 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.

Study Timeline

• Study Start: 2013-04
• Status Verified: 2013-05
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-15
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2020-03-07
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Switching to NPH insulin	Switching to NPH insulin	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.
Continuation of insulin glargine	Continuation of insulin glargine	Patients in this arm will continue on insulin glargine and serve as a control group.

Primary Outcome Measures

Name	Time	Method
Difference in A1C between groups at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
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 A1C between groups at 3 months	3 months
Difference in incidence of hypoglycemia between each group	6 months	* 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
Difference in self-monitored blood glucose averages between groups	6 months	Outside of A1C, the investigators will also be comparing self-monitored blood glucose averages within each group and comparing them to one another.
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
Differences in change in weight during study period between groups	6 months	Weight change in each patient will be calculated using weight at study initiation and completion
Difference in number of visits with clinical pharmacist	6 months
Difference in morbidity between each group during study period	6 months	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)
Compare cost of insulin therapy over study period at study completion	6 months	Costs will be calculated as direct patient cost and total cost of medication.

Trial Locations

Locations (1)

Providence Medical Group Northeast Clinic; 🇺🇸 Portland, Oregon, United States