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Comparison Study of Insulin Glargine and NPH Insulin

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ClinicalTrials.gov Identifier: NCT01854723
Recruitment Status : Unknown
Verified May 2013 by Providence Health & Services.
Recruitment status was:  Enrolling by invitation
First Posted : May 15, 2013
Last Update Posted : May 22, 2013
Sponsor:
Information provided by (Responsible Party):
Providence Health & Services

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

Condition or disease Intervention/treatment Phase
Diabetes Drug: Switching to NPH insulin Drug: Continuation of insulin glargine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Basal Insulin Therapy in Patients With Insulin Resistance: A 6 Month Comparison of Insulin Glargine and NPH Insulin
Study Start Date : April 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Humulin N
  • Novolin N
  • Novolin NPH
  • NPH Iletin II
  • Isophane insulin

Active Comparator: Continuation of insulin glargine
Patients in this arm will continue on insulin glargine and serve as a control group.
Drug: Continuation of insulin glargine
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.
Other Name: Lantus




Primary Outcome Measures :
  1. Difference in A1C between groups at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Difference in A1C between groups at 3 months [ Time Frame: 3 months ]
  2. Difference in self-monitored blood glucose averages between groups [ Time Frame: 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.

  3. Difference in incidence of hypoglycemia between each group [ Time Frame: 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

  4. Difference in units of basal insulin used per day between groups [ Time Frame: 6 months ]
  5. Difference in total units of insulin per day between groups [ Time Frame: 6 months ]
  6. Difference in percent of patients who require initiation/titration of prandial insulin between each group [ Time Frame: 6 months ]
  7. Difference in rate of mortality in each group during study period [ Time Frame: 6 months ]
  8. Difference in morbidity between each group during study period [ Time Frame: 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)

  9. Compare cost of insulin therapy over study period at study completion [ Time Frame: 6 months ]
    Costs will be calculated as direct patient cost and total cost of medication.

  10. Differences in change in weight during study period between groups [ Time Frame: 6 months ]
    Weight change in each patient will be calculated using weight at study initiation and completion

  11. Difference in number of visits with clinical pharmacist [ Time Frame: 6 months ]


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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854723


Locations
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United States, Oregon
Providence Medical Group Northeast Clinic
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Providence Health & Services
Investigators
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Principal Investigator: Elizabeth Stephens, MD Providence Medical Group

Publications:

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Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT01854723     History of Changes
Other Study ID Numbers: 13-029B
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013
Keywords provided by Providence Health & Services:
Diabetes
Insulin glargine
NPH insulin
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin, Isophane
Isophane Insulin, Human
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs