Comparison Study of Insulin Glargine and NPH Insulin

Providence Health & Services

Status and phase: Withdrawn; Phase 4

Conditions: Diabetes

Treatments: Drug: Switching to NPH insulin; Drug: Continuation of insulin glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT01854723

13-029B

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: Under 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Switching to NPH insulin

Experimental group

Description:

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.

Treatment:

Drug: Switching to NPH insulin

Continuation of insulin glargine

Active Comparator group

Description:

Patients in this arm will continue on insulin glargine and serve as a control group.

Treatment:

Drug: Continuation of insulin glargine