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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin Glargine Sansulin
* Drug: Insulin Glargine Pen Injector [Lantus]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin glargine biosimilar, diabetes mellitus, efficacy, safety, immunogenicity