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

Diabetes Mellitus Clinical Trial

Official title:

The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin® Log-G With Its Reference Lantus® in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04591457
• Other study ID #: IndonesiaU-03
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 2020
• Est. completion date: August 2021

Study information

• Verified date: October 2020
• Source: Indonesia University
• Contact: Tri Juli Edi Tarigan, MD
• Phone: 62 813 1544 83293
• Email: tje_tar[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Insulin Glargine Sansulin
Insulin Glargine (Sansulin Log-G) once daily at individually adjusted dose
• Insulin Glargine Pen Injector [Lantus]
Insulin Glargine (Lantus) once daily at individually adjusted dose

Locations

Country	Name	City	State
Indonesia	Department of Internal Medicine Cipto Mangunkusumo General Hospital, Faculty of Medicine Universitas Indonesia	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Change in HbA1c level after 24 weeks of therapy compared to baseline value	24 weeks
Primary	Number of patients	Number of patients with HbA1c < 7%	24 weeks
Primary	Anti-insulin antibodies (AIAs)	Change in anti-insulin antibodies (AIAs) after 24 weeks of therapy compared to baseline value	24 weeks
Secondary	FBG & PPBG	Change in FBG & PPBG compared to baseline	24 weeks
Secondary	Hypoglycemia	Incidence and severity of hypoglycemia	24 weeks
Secondary	Weight gain	Incidence of weight gain	24 weeks
Secondary	Adverse events	Incidence and severity of adverse events	24 weeks