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

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

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

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Insulin Glargine Pen Injector [Lantus]; Drug: Insulin Glargine Sansulin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10520
      • Department of Internal Medicine Cipto Mangunkusumo General Hospital, Faculty of Medicine Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin Glargine Sansulin; Drug product Insulin Glargine, Sansulin Log-G 100 IU/mL (PT. Sanbe Farma)	Drug: Insulin Glargine Sansulin; Insulin Glargine (Sansulin Log-G) once daily at individually adjusted dose; Other Names: Sansulin
Active Comparator: Insulin Glargine Lantus; Drug product Insulin Glargine, Pen Injector [Lantus] 100 IU/mL (PT. Sanofi-Aventis)	Drug: Insulin Glargine Pen Injector [Lantus]; Insulin Glargine (Lantus) once daily at individually adjusted dose; Other Names: Lantus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Change in HbA1c level after 24 weeks of therapy compared to baseline value	24 weeks
Number of patients	Number of patients with HbA1c < 7%	24 weeks
Anti-insulin antibodies (AIAs)	Change in anti-insulin antibodies (AIAs) after 24 weeks of therapy compared to baseline value	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FBG & PPBG	Change in FBG & PPBG compared to baseline	24 weeks
Hypoglycemia	Incidence and severity of hypoglycemia	24 weeks
Weight gain	Incidence of weight gain	24 weeks
Adverse events	Incidence and severity of adverse events	24 weeks

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Tri Juli Edi Tarigan, Cipto Mangunkusumo General Hospital/Faculty of Medicine Universitas Indonesia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: October 10, 2020
• First Submitted That Met QC Criteria: October 10, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 10, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: safety; efficacy; immunogenicity; diabetes mellitus; Insulin glargine biosimilar
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine
• Other Study ID Numbers: IndonesiaU-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No