Clinical trial NCT01854723: Comparison Study of Insulin Glargine and NPH Insulin
Official title: Basal Insulin Therapy in Patients With Insulin Resistance: A 6 Month Comparison of Insulin Glargine and NPH Insulin
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Diabetes
Keywords: Diabetes
Insulin glargine
NPH insulin
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 0
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Difference in A1C between groups at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Difference in A1C between groups at 3 months
timeFrame: 3 months
measure: Difference in self-monitored blood glucose averages between groups
timeFrame: 6 months
measure: Difference in incidence of hypoglycemia between each group
timeFrame: 6 months
measure: Difference in units of basal insulin used per day between groups
timeFrame: 6 months
measure: Difference in total units of insulin per day between groups
timeFrame: 6 months
measure: Difference in percent of patients who require initiation/titration of prandial insulin between each group
timeFrame: 6 months
measure: Difference in rate of mortality in each group during study period
timeFrame: 6 months
measure: Difference in morbidity between each group during study period
timeFrame: 6 months
measure: Compare cost of insulin therapy over study period at study completion
timeFrame: 6 months
measure: Differences in change in weight during study period between groups
timeFrame: 6 months
measure: Difference in number of visits with clinical pharmacist
timeFrame: 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Providence Medical Group Northeast Clinic
state: Oregon
Study officials:
affiliation: Providence Medical Group
name: Elizabeth Stephens, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.