The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin Log-G to Lantus

Last updated: October 10, 2020
Sponsor: Indonesia University
Overall Status: Active - Not Recruiting

Phase

2

Condition

Diabetes Prevention

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT04591457
IndonesiaU-03
  • Ages > 18
  • All Genders

Study Summary

This is an open-label randomised multicenter clinical study to investigate efficacy, safety, and immunogenicity of the drug products: Insulin Glargine biosimilar ® Log-G and its reference Lantus® in type 2 diabetes mellitus patients

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with DM type 2, age at least 18 years, both genders.

  2. T2DM patients who have been diagnosed for > 1 year, and have been treated with oneoral antidiabetic at stable doses for > 3 months prior to screening, have BMI of 18.0to 35.0 kg/m2 inclusive, and HbA1C of > 7.0% and insulin-naive.

  3. Patients who are cooperative, reliable, and agree to have regular injections ofinsulin, and are willing to comply with protocol procedure (willing to sign theinformed consent).

  4. Female patients with adequate protection from conception. Females of childbearingpotential must use a reliable method of birth control during the study (barrier-methodor IUD). Women with history of bilateral tubal ligation, or with total hysterectomy,or who are 2 years postmenopausal are also eligible.

Exclusion

Exclusion Criteria:

  1. Pregnancy (confirmed by a positive urine pregnancy test) or lactation.

  2. History of severe hypoglycemia during the last year (blood glucose level <50 mg/dlwith transient dysfunction of central nervous system without other apparent cause)

  3. History of diabetic ketoacidosis > 2x within the last year.

  4. Having hyperglycemia hyperosmolar status (HHS)

  5. Renal impairment (eGFR < 30 mL/min).

  6. An employee of the Investigator or the Sponsor.

  7. Participating in another clinical study within the past 3 months.

  8. Receiving any immunosuppressants, including corticosteroids or cytostatics within thelast year or during the study.

  9. Receiving any drug or supplement with hypoglycemic activity (except oralantidiabetics) within 4 weeks prior to screening and during the study.

  10. Receiving any drug with hyperglycemic activity within 4 weeks prior to screening andduring the study (eg. second generation antipsychotics, corticosteroids, tacrolimus,protease inhibitors).

  11. Have undergone pancreatectomy or pancreas / islet cell transplant.

  12. Mental disorder

  13. Any malignancies

Study Design

Total Participants: 120
Study Start date:
October 01, 2020
Estimated Completion Date:
August 31, 2021

Study Description

Sansulin® Log-G is an insulin glargine biosimilar. For a biosimilar, its efficacy, safety, and immunogenicity should be compared head-to-head with its reference product in at least non-inferiority study. Immunogenicity assessment should always be done because it is influenced by so many factors, from nature of the drug substance until patient and disease related factors. Moreover its consequences also vary considerably, from clinically irrelevant to serious and life-threatening. Immunogenicity of a biosimilar should always be investigated in humans, since animal data are usually not predictive of the immune response in humans.

Since blinding of study participants is likely unfeasible, at least anti-drug antibodies should be determined in a blinded fashion. Since anti-insulin antibodies develop early, then 6 months duration of study is adequate.

Connect with a study center

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

    Jakarta Pusat, Jakarta 10520
    Indonesia

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.