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

NCT04591457 | Unknown Phase 2 DMC

• 1 other identifier: IndonesiaU-03
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus

Keywords

Insulin glargine biosimilar; diabetes mellitus; efficacy; safety; immunogenicity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• FBG & PPBG

  24 weeks

• Hypoglycemia

  24 weeks

• Weight gain

  24 weeks

• Adverse events

  24 weeks

Study Arms (2)

Insulin Glargine Sansulin

EXPERIMENTAL

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

Drug: Insulin Glargine Sansulin

Insulin Glargine Lantus

ACTIVE COMPARATOR

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

Drug: Insulin Glargine Pen Injector [Lantus]

Interventions

Insulin Glargine Sansulin DRUG

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

Also known as: Sansulin

Insulin Glargine Sansulin

Insulin Glargine Pen Injector [Lantus] DRUG

Insulin Glargine (Lantus) once daily at individually adjusted dose

Also known as: Lantus

Insulin Glargine Lantus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy (confirmed by a positive urine pregnancy test) or lactation.
• 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)
• History of diabetic ketoacidosis \> 2x within the last year.
• Having hyperglycemia hyperosmolar status (HHS)
• Renal impairment (eGFR \< 30 mL/min).
• An employee of the Investigator or the Sponsor.
• Participating in another clinical study within the past 3 months.
• Receiving any immunosuppressants, including corticosteroids or cytostatics within the last year or during the study.
• Receiving any drug or supplement with hypoglycemic activity (except oral antidiabetics) within 4 weeks prior to screening and during the study.
• Receiving any drug with hyperglycemic activity within 4 weeks prior to screening and during the study (eg. second generation antipsychotics, corticosteroids, tacrolimus, protease inhibitors).
• Have undergone pancreatectomy or pancreas / islet cell transplant.
• Mental disorder
• Any malignancies

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

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

Jakarta Pusat, Jakarta Special Capital Region, 10520, Indonesia

Location

Related 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.

  PMID: 21907589 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Tri Juli Edi Tarigan

  Cipto Mangunkusumo General Hospital/Faculty of Medicine Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tri Juli Edi Tarigan, MD

CONTACT

62 813 1544 83293; tje_tar@yahoo.com

Nida Amalina, PH

CONTACT

62 856 9703 6895; amalinanida@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist, Principal Investigator

Study Record Dates

• First Submitted: October 10, 2020
• First Posted: October 19, 2020
• Study Start: October 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)