Comparison Study of Insulin Glargine and NPH Insulin

Diabetes Clinical Trial

Official title:

Basal Insulin Therapy in Patients With Insulin Resistance: A 6 Month Comparison of Insulin Glargine and NPH Insulin

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01854723
• Other study ID #: 13-029B
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: May 2013
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Providence Medical Group Northeast Clinic	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Providence Health & Services

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View Citation

Fritsche A, Schweitzer MA, Häring 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Yki-Järvinen H, Kauppinen-Mäkelin R, Tiikkainen M, Vähätalo M, Virtamo H, Nikkilä K, Tulokas T, Hulme S, Hardy K, McNulty S, Hänninen J, Levänen H, Lahdenperä 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. Epub 2006 Feb 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in A1C between groups at 6 months		6 months
Secondary	Difference in A1C between groups at 3 months		3 months
Secondary	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.	6 months
Secondary	Difference in incidence of hypoglycemia between each group	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	6 months
Secondary	Difference in units of basal insulin used per day between groups		6 months
Secondary	Difference in total units of insulin per day between groups		6 months
Secondary	Difference in percent of patients who require initiation/titration of prandial insulin between each group		6 months
Secondary	Difference in rate of mortality in each group during study period		6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Difference in number of visits with clinical pharmacist		6 months