Clinical trial NCT04591457: The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin Log-G to Lantus
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetes Mellitus
Keywords: Insulin glargine biosimilar
diabetes mellitus
efficacy
safety
immunogenicity
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: HbA1c
timeFrame: 24 weeks
measure: Number of patients
timeFrame: 24 weeks
measure: Anti-insulin antibodies (AIAs)
timeFrame: 24 weeks
Secondary outcomes:
measure: FBG & PPBG
timeFrame: 24 weeks
measure: Hypoglycemia
timeFrame: 24 weeks
measure: Weight gain
timeFrame: 24 weeks
measure: Adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Department of Internal Medicine Cipto Mangunkusumo General Hospital, Faculty of Medicine Universitas Indonesia
state: Jakarta
Study officials:
affiliation: Cipto Mangunkusumo General Hospital/Faculty of Medicine Universitas Indonesia
name: Tri Juli Edi Tarigan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.