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Diabetes MellitusPhase 2NCT03352674

Immunogenicity Study of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients

A Phase 2 study testing Insulin Glargine Ezelin and Insulin Glargine Pen Injector [Lantus] in people with Diabetes Mellitus, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label randomised multicenter clinical study to compare immunogenicity of the drug products Insulin Glargine (Kalbe Farma) and Lantus (Sanofi -Aventis) in type 2 diabetes mellitus patients Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus
What is being tested?
Insulin Glargine Ezelin and Insulin Glargine Pen Injector [Lantus]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
133 participants
Where
1 siteIndonesia
Study dates
Sep 2016to 1 Dec 2018
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women, 18 years old and above
  • Diabetes mellitus type 2 patients who has failed an oral hypoglycemic drug products, insulin-naive, disease duration of at least 6 months, inadequate glycemic control (HbA1c > 7.0 %)
  • BMI ranged from 19 - 35 kg/m2
  • Consent from patients of childbearing potential to use contraception method throughout the study
  • Signed informed consent form

Who cannot join

  • History of diabetic ketoacidosis more than 2 times in the past 1 year
  • History of pancreatectomy
  • Estimated glomerular filtration rate <30 mL/min
  • Positive ZnT8 Antibody
  • Treatment with glucocorticoids, immunodepressant or cytostatics in 60 days before study.
  • Any malignant disease, including in medical history
Show all 9Show fewer
  • Drugs and alcohol abuse, including in medical history
  • Hipersensitivity to insulin glargine or any excipient of the drugs from medical history
  • Mental disorders

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Department of Internal Medicine Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia

    Jakarta Pusat, Jakarta Special Capital Region, 10520

Other trials in Indonesia

About this study

Official title: Open Label Randomized Multicenter Clinical Trial to Compare Immunogenicity of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients

This is an open-label randomised multicenter clinical study to compare immunogenicity of the drug products Insulin Glargine (Kalbe Farma) and Lantus (Sanofi -Aventis) in type 2 diabetes mellitus patients

Read the detailed description

Previous study has revealed that Insulin Glargine (Kalbe Farma) has similar efficacy with Lantus (Sanofi-Aventis) in controlling blood glucose in type 2 diabetes mellitus patients, but the immunogenicity potential of this product has not been known. Therefore, the present study is aiming to compare immunogenicity of Insulin Glargine (Kalbe Farma) and Lantus (Sanofi-Aventis) in type 2 diabetes mellitus patients in an open-label randomised multicenter clinical study.

Being tested
Insulin Glargine Ezelin, Insulin Glargine Pen Injector [Lantus]
Keywords
insulin glargine, diabetes mellitus, immunogenicity
Medical subject headings
Diabetes Mellitus

What participants receive

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

  • Insulin Glargine EzelinDrug

    Also called Ezelin

    Insulin Glargine (Ezelin) once daily at individually adjusted dose

  • Insulin Glargine Pen Injector [Lantus]Drug

    Also called Lantus

    Insulin Glargine (Lantus) once daily at individually adjusted dose

Study groups in NCT03352674
Study groupRoleWhat they receive
Insulin Glargine EzelinExperimentalDrug product Insulin Glargine, Ezelin 100 U/mL (PT Kalbe Farma, Tbk)
Receives: Drug: Insulin Glargine Ezelin
Insulin Glargine LantusActive comparatorInsulin Glargine Pen Injector [Lantus]
Receives: Drug: Insulin Glargine Pen Injector [Lantus]

What is being measured

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

  1. Incidence of immune response

    Production of antibodies against insulin /IAA and ZnT8 antibody in investigational drug product and comparator groups

    Measured: 6 months

Secondary outcomes (4)

  1. HbA1c

    change in HbA1c level after 6 months of therapy compared to baseline value

    Measured: 6 months

  2. Fasting blood glucose

    Change in fasting blood glucose

    Measured: 6 months

  3. Hypoglycemia

    Incidence and severity of hypoglycaemia cases

    Measured: 6 months

  4. Adverse events

    Incidence and severity of adverse events

    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 posted24 Nov 2017
  2. Study startSep 2016
  3. Primary completion1 Dec 2018
  4. Study completion1 Dec 2018

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03352674
Sponsor's protocol ID
IndonesiaU-01
Status last verified
Mar 2020
First submitted
14 Oct 2017
Last updated
1 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chakkarwar PN, Manjrekar NA. Insulin glargine: a long acting insulin analog. J Postgrad Med. 2005 Jan-Mar;51(1):68-71.

    PubMed 15793346

  • McKeage K, Goa KL. Insulin glargine: a review of its therapeutic use as a long-acting agent for the management of type 1 and 2 diabetes mellitus. Drugs. 2001;61(11):1599-624. doi: 10.2165/00003495-200161110-00007.

    PubMed 11577797

  • Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, Dagogo-Jack S, Davidson MB, Einhorn D, Garvey WT, Grunberger G, Handelsman Y, Hirsch IB, Jellinger PS, McGill JB, Mechanick JI, Rosenblit PD, Umpierrez G, Davidson MH; American Association of Clinical Endocrinologists. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013 Mar-Apr;19(2):327-36. doi: 10.4158/endp.19.2.a38267720403k242. No abstract available.

    PubMed 23598536

  • Pihoker C, Gilliam LK, Hampe CS, Lernmark A. Autoantibodies in diabetes. Diabetes. 2005 Dec;54 Suppl 2:S52-61. doi: 10.2337/diabetes.54.suppl_2.s52.

    PubMed 16306341

  • Bingley PJ. Clinical applications of diabetes antibody testing. J Clin Endocrinol Metab. 2010 Jan;95(1):25-33. doi: 10.1210/jc.2009-1365. Epub 2009 Oct 29.

    PubMed 19875480

  • Vaziri-Sani F, Oak S, Radtke J, Lernmark K, Lynch K, Agardh CD, Cilio CM, Lethagen AL, Ortqvist E, Landin-Olsson M, Torn C, Hampe CS. ZnT8 autoantibody titers in type 1 diabetes patients decline rapidly after clinical onset. Autoimmunity. 2010 Dec;43(8):598-606. doi: 10.3109/08916930903555927. Epub 2010 Mar 19.

    PubMed 20298127

  • Pan CY, Sinnassamy P, Chung KD, Kim KW; LEAD Study Investigators Group. Insulin glargine versus NPH insulin therapy in Asian Type 2 diabetes patients. Diabetes Res Clin Pract. 2007 Apr;76(1):111-8. doi: 10.1016/j.diabres.2006.08.012. Epub 2006 Oct 2.

    PubMed 17011662

  • Rosenstock J, Dailey G, Massi-Benedetti M, Fritsche A, Lin Z, Salzman A. Reduced hypoglycemia risk with insulin glargine: a meta-analysis comparing insulin glargine with human NPH insulin in type 2 diabetes. Diabetes Care. 2005 Apr;28(4):950-5. doi: 10.2337/diacare.28.4.950.

    PubMed 15793205

  • Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia. 2008 Mar;51(3):408-16. doi: 10.1007/s00125-007-0911-x. Epub 2008 Jan 16.

    PubMed 18204830

  • 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

  • Stumvoll M, Goldstein BJ, van Haeften TW. Type 2 diabetes: principles of pathogenesis and therapy. Lancet. 2005 Apr 9-15;365(9467):1333-46. doi: 10.1016/S0140-6736(05)61032-X.

    PubMed 15823385

  • Rubin RR, Peyrot M, Siminerio LM. Health care and patient-reported outcomes: results of the cross-national Diabetes Attitudes, Wishes and Needs (DAWN) study. Diabetes Care. 2006 Jun;29(6):1249-55. doi: 10.2337/dc05-2494.

    PubMed 16732004

  • Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.

    PubMed 15111519

  • Yki-Jarvinen H, Juurinen L, Alvarsson M, Bystedt T, Caldwell I, Davies M, Lahdenpera S, Nijpels G, Vahatalo M. Initiate Insulin by Aggressive Titration and Education (INITIATE): a randomized study to compare initiation of insulin combination therapy in type 2 diabetic patients individually and in groups. Diabetes Care. 2007 Jun;30(6):1364-9. doi: 10.2337/dc06-1357. Epub 2007 Mar 23.

    PubMed 17384341

  • Tarigan TJE, Dwijayanti A, Setyowati S, Louisa M. Immunogenicity and Efficacy of Insulin Glargine Biosimilar Ezelin versus Originator Insulin Glargine in Patients with Type 2 Diabetes. Diabetes Metab Syndr Obes. 2021 Jan 12;14:107-116. doi: 10.2147/DMSO.S279385. eCollection 2021.

    PubMed 33469328

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Insulin Glargine Ezelin and Insulin Glargine Pen Injector [Lantus] in people with Diabetes Mellitus, run by Universitas Indonesia at 1 site in Indonesia.

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 5 inclusion and 9 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: finished, as of the sponsor's last update on 1 Apr 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 Indonesia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of immune response (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 NCT03352674, which also lists 15 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 1 Apr 2020.

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