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DiabetesPhase 4NCT01854723

Comparison Study of Insulin Glargine and NPH Insulin

A Phase 4 study testing Switching to NPH insulin and Continuation of insulin glargine in people with Diabetes, run by Providence Health & Services at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages Up to 85 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes
What is being tested?
Switching to NPH insulin and Continuation of insulin glargine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2013to Dec 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Providence Medical Group Northeast Clinic

    Portland, Oregon, 97213

Other trials in United States

About this study

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

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

Read the 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.

Conditions
Diabetes
Being tested
Switching to NPH insulin, Continuation of insulin glargine
Keywords
Diabetes, Insulin glargine, NPH insulin
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Switching to NPH insulinDrug

    Also called Humulin N, Novolin N, Novolin NPH, NPH Iletin II

    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 glargineDrug

    Also called Lantus

    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.

Study groups in NCT01854723
Study groupRoleWhat they receive
Switching to NPH insulinExperimentalPatients 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.
Receives: Drug: Switching to NPH insulin
Continuation of insulin glargineActive comparatorPatients in this arm will continue on insulin glargine and serve as a control group.
Receives: Drug: Continuation of insulin glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in A1C between groups at 6 months

    Measured: 6 months

Secondary outcomes (11)

  1. Difference in A1C between groups at 3 months

    Measured: 3 months

  2. 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.

    Measured: 6 months

  3. 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

    Measured: 6 months

  4. Difference in units of basal insulin used per day between groups

    Measured: 6 months

  5. Difference in total units of insulin per day between groups

    Measured: 6 months

  6. Difference in percent of patients who require initiation/titration of prandial insulin between each group

    Measured: 6 months

  7. Difference in rate of mortality in each group during study period

    Measured: 6 months

  8. 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)

    Measured: 6 months

  9. Compare cost of insulin therapy over study period at study completion

    Costs will be calculated as direct patient cost and total cost of medication.

    Measured: 6 months

  10. 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

    Measured: 6 months

  11. Difference in number of visits with clinical pharmacist

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01854723
Sponsor's protocol ID
13-029B
Status last verified
May 2013
First submitted
13 May 2013
Last updated
10 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20357371

  • 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.

    PubMed 12809451

  • 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.

    PubMed 16715577

  • 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.

    PubMed 16456680

  • 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.

    PubMed 14578243

  • 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.

    PubMed 12734781

  • 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.

    PubMed 11315821

  • 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.

    PubMed 22232027

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Switching to NPH insulin and Continuation of insulin glargine in people with Diabetes, run by Providence Health & Services at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in A1C between groups at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01854723, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.

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