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This study will compare the safety, effectiveness, and cost of two different types of long-acting insulin.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Switching to NPH insulin | Experimental | 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 | Active Comparator | Patients in this arm will continue on insulin glargine and serve as a control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Switching to NPH insulin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in A1C between groups at 6 months | 6 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Stephens, MD | Providence Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Medical Group Northeast Clinic | Portland | Oregon | 97213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20357371 | Background | Wang Z, Hedrington MS, Gogitidze Joy N, Briscoe VJ, Richardson MA, Younk L, Nicholson W, Tate DB, Davis SN. Dose-response effects of insulin glargine in type 2 diabetes. Diabetes Care. 2010 Jul;33(7):1555-60. doi: 10.2337/dc09-2011. Epub 2010 Mar 31. | |
| 12809451 | Background | Fritsche A, Schweitzer MA, Haring HU; 4001 Study Group. Glimepiride combined with morning insulin glargine, bedtime neutral protamine hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. A randomized, controlled trial. Ann Intern Med. 2003 Jun 17;138(12):952-9. doi: 10.7326/0003-4819-138-12-200306170-00006. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068880 | Isophane Insulin, Human |
| D007336 | Insulin, Isophane |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Continuation of insulin glargine | Drug | 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. |
|
|
| 6 months |
| Difference in incidence of hypoglycemia between each group |
| 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 |
| 16715577 | Background | Eliaschewitz FG, Calvo C, Valbuena H, Ruiz M, Aschner P, Villena J, Ramirez LA, Jimenez J; HOE 901/4013 LA Study Group. Therapy in type 2 diabetes: insulin glargine vs. NPH insulin both in combination with glimepiride. Arch Med Res. 2006 May;37(4):495-501. doi: 10.1016/j.arcmed.2005.10.015. |
| 16456680 | Background | Yki-Jarvinen H, Kauppinen-Makelin R, Tiikkainen M, Vahatalo M, Virtamo H, Nikkila K, Tulokas T, Hulme S, Hardy K, McNulty S, Hanninen J, Levanen H, Lahdenpera S, Lehtonen R, Ryysy L. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia. 2006 Mar;49(3):442-51. doi: 10.1007/s00125-005-0132-0. Epub 2006 Feb 3. |
| 14578243 | Background | Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003 Nov;26(11):3080-6. doi: 10.2337/diacare.26.11.3080. |
| 12734781 | Background | Massi Benedetti M, Humburg E, Dressler A, Ziemen M. A one-year, randomised, multicentre trial comparing insulin glargine with NPH insulin in combination with oral agents in patients with type 2 diabetes. Horm Metab Res. 2003 Mar;35(3):189-96. doi: 10.1055/s-2003-39080. |
| 11315821 | Background | Rosenstock J, Schwartz SL, Clark CM Jr, Park GD, Donley DW, Edwards MB. Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine (HOE 901) and NPH insulin. Diabetes Care. 2001 Apr;24(4):631-6. doi: 10.2337/diacare.24.4.631. |
| 22232027 | Background | Bota VM, Hirsch IB. Insulin glargine or neutral protamine Hagedorn in patients with severe insulin resistance: Is there a benefit? Endocr Pract. 2012 May-Jun;18(3):e49-51. doi: 10.4158/EP11302.CR. |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D061386 | Insulin, Regular, Human |
| D007328 | Insulin |
| D011384 | Proinsulin |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |