Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2013-04-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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
Patients in this arm will continue on insulin glargine and serve as a control group.
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.
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
85 Years
ALL
Yes
Sponsors
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Providence Health & Services
OTHER
Responsible Party
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Principal Investigators
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Elizabeth Stephens, MD
Role: PRINCIPAL_INVESTIGATOR
Providence Medical Group
Locations
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Providence Medical Group Northeast Clinic
Portland, Oregon, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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13-029B
Identifier Type: -
Identifier Source: org_study_id
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