NCT01854723

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2013

Typical duration for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 10, 2020

Status Verified

May 1, 2013

Enrollment Period

2.7 years

First QC Date

May 13, 2013

Last Update Submit

March 7, 2020

Conditions

Diabetes

Keywords

DiabetesInsulin glargineNPH insulin

Outcome Measures

Primary Outcomes (1)

  • Difference in A1C between groups at 6 months

    6 months

Secondary Outcomes (11)

  • Difference in A1C between groups at 3 months

    3 months

  • Difference in self-monitored blood glucose averages between groups

    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

  • +6 more secondary outcomes

Study Arms (2)

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.

Drug: Switching to NPH insulin

Continuation of insulin glargine

ACTIVE COMPARATOR

Patients in this arm will continue on insulin glargine and serve as a control group.

Drug: Continuation of insulin glargine

Interventions

Switching to NPH insulinDRUG

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.

Also known as: Humulin N, Novolin N, Novolin NPH, NPH Iletin II, Isophane insulin
Switching to NPH insulin
Continuation of insulin glargineDRUG

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.

Also known as: Lantus
Continuation of insulin glargine

Eligibility Criteria

AgeUp to 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence Medical Group Northeast Clinic

Portland, Oregon, 97213, United States

Location

Related Publications (8)

  • 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.

    PMID: 20357371BACKGROUND

  • 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.

    PMID: 12809451BACKGROUND

  • 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.

    PMID: 16715577BACKGROUND

  • 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.

    PMID: 16456680BACKGROUND

  • 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.

    PMID: 14578243BACKGROUND

  • 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.

    PMID: 12734781BACKGROUND

  • 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.

    PMID: 11315821BACKGROUND

  • 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.

    PMID: 22232027BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Isophane Insulin, HumanInsulin, IsophaneInsulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsInsulin, Regular, HumanInsulinProinsulinPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Elizabeth Stephens, MD

    Providence Medical Group

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 15, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 10, 2020

Record last verified: 2013-05

Locations

US(1)