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

NCT ID: NCT04591457

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2021-08-31

Brief 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

Detailed 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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Insulin Glargine Sansulin

Drug product Insulin Glargine, Sansulin Log-G 100 IU/mL (PT. Sanbe Farma)

Group Type: EXPERIMENTAL

Insulin Glargine Sansulin

Intervention Type: DRUG

Insulin Glargine (Sansulin Log-G) once daily at individually adjusted dose

Insulin Glargine Lantus

Drug product Insulin Glargine, Pen Injector \[Lantus\] 100 IU/mL (PT. Sanofi-Aventis)

Group Type: ACTIVE_COMPARATOR

Insulin Glargine Pen Injector [Lantus]

Intervention Type: DRUG

Insulin Glargine (Lantus) once daily at individually adjusted dose

Interventions

Insulin Glargine Sansulin

Insulin Glargine (Sansulin Log-G) once daily at individually adjusted dose

Intervention Type: DRUG

Insulin Glargine Pen Injector [Lantus]

Insulin Glargine (Lantus) once daily at individually adjusted dose

Intervention Type: DRUG

Other Intervention Names

Sansulin; Lantus

Eligibility Criteria

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 one oral antidiabetic at stable doses for > 3 months prior to screening, have BMI of 18.0 to 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 of insulin, and are willing to comply with protocol procedure (willing to sign the informed consent).

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

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/dl with 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 the last year or during the study.

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

10. Receiving any drug with hyperglycemic activity within 4 weeks prior to screening and during 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Dr Tri Juli Edi Tarigan, SpPD-KEMD

Endocrinologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tri Juli Edi Tarigan

Role: PRINCIPAL_INVESTIGATOR

Cipto Mangunkusumo General Hospital/Faculty of Medicine Universitas Indonesia

Locations

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

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

Central Contacts

Tri Juli Edi Tarigan, MD

Role: CONTACT

tje_tar@yahoo.com

62 813 1544 83293

Nida Amalina, PH

Role: CONTACT

amalinanida@gmail.com

62 856 9703 6895

Facility Contacts

Tri Juli Edi Tarigan, MD

Role: primary

tje_tar@yahoo.com

+62 813 15 483 293

Nida Amalina, PH

Role: backup

amalinanida@gmail.com

+62 856 9703 6895

References

Knezevic I. Evaluation of similar biotherapeutic products (SBPs): scientific principles and their implementation. Biologicals. 2011 Sep;39(5):256-61. doi: 10.1016/j.biologicals.2011.08.008. Epub 2011 Sep 9.

Reference Type: RESULT

PMID: 21907589 (View on PubMed)

Other Identifiers

IndonesiaU-03

Identifier Type: -

Identifier Source: org_study_id