Diabetes MellitusPhase 2NCT04591457
The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin Log-G to Lantus
A Phase 2 study testing Insulin Glargine Sansulin and Insulin Glargine Pen Injector [Lantus] in people with Diabetes Mellitus, run by Universitas Indonesia at 1 site in Indonesia.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Insulin Glargine Sansulin and Insulin Glargine Pen Injector [Lantus]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndonesia
- Study dates
- Oct 2020to Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Department of Internal Medicine Cipto Mangunkusumo General Hospital, Faculty of Medicine Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10520
Tri Juli Edi Tarigan, MD, +62 813 15 483 293, tje_tar@yahoo.com
Nida Amalina, PH, +62 856 9703 6895, amalinanida@gmail.com
About this study
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
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
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Insulin Glargine Sansulin, Insulin Glargine Pen Injector [Lantus]
- Keywords
- Insulin glargine biosimilar, diabetes mellitus, efficacy, safety, immunogenicity
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Glargine SansulinDrug
Also called Sansulin
Insulin Glargine (Sansulin Log-G) once daily at individually adjusted dose
Insulin Glargine Pen Injector [Lantus]Drug
Also called Lantus
Insulin Glargine (Lantus) once daily at individually adjusted dose
| Study group | Role | What they receive |
|---|---|---|
| Insulin Glargine Sansulin | Experimental | Drug product Insulin Glargine, Sansulin Log-G 100 IU/mL (PT. Sanbe Farma) Receives: Drug: Insulin Glargine Sansulin |
| Insulin Glargine Lantus | Active comparator | Drug product Insulin Glargine, Pen Injector [Lantus] 100 IU/mL (PT. Sanofi-Aventis) Receives: Drug: Insulin Glargine Pen Injector [Lantus] |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change in HbA1c level after 24 weeks of therapy compared to baseline value
Measured: 24 weeks
Number of patients
Number of patients with HbA1c < 7%
Measured: 24 weeks
Anti-insulin antibodies (AIAs)
Change in anti-insulin antibodies (AIAs) after 24 weeks of therapy compared to baseline value
Measured: 24 weeks
Secondary outcomes (4)
FBG & PPBG
Change in FBG \& PPBG compared to baseline
Measured: 24 weeks
Hypoglycemia
Incidence and severity of hypoglycemia
Measured: 24 weeks
Weight gain
Incidence of weight gain
Measured: 24 weeks
Adverse events
Incidence and severity of adverse events
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study startOct 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Tri Juli Edi Tarigan, SpPD-KEMD, Universitas Indonesia
- Investigators
- Tri Juli Edi Tarigan, Principal investigator, Cipto Mangunkusumo General Hospital/Faculty of Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591457
- Sponsor's protocol ID
- IndonesiaU-03
- Status last verified
- Oct 2020
- First submitted
- 10 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21907589
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04591457
- Acronym / sponsor ID
- IndonesiaU-03
- Conditions
- Diabetes Mellitus
- Keywords
- Insulin glargine biosimilar, diabetes mellitus, efficacy, safety, immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Glargine Sansulin | Experimental | Drug: Insulin Glargine SansulinDrug product Insulin Glargine, Sansulin Log-G 100 IU/mL (PT. Sanbe Farma) |
| Insulin Glargine Lantus | Active comparator | Drug: Insulin Glargine Pen Injector [Lantus]Drug product Insulin Glargine, Pen Injector [Lantus] 100 IU/mL (PT. Sanofi-Aventis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Glargine SansulinAlso: SansulinInsulin Glargine (Sansulin Log-G) once daily at individually adjusted dose | Drug | Insulin Glargine Sansulin |
| Insulin Glargine Pen Injector [Lantus]Also: LantusInsulin Glargine (Lantus) once daily at individually adjusted dose | Drug | Insulin Glargine Lantus |
Primary outcome
HbA1c
Time frame: 24 weeks
Change in HbA1c level after 24 weeks of therapy compared to baseline value
Number of patients
Time frame: 24 weeks
Number of patients with HbA1c < 7%
Anti-insulin antibodies (AIAs)
Time frame: 24 weeks
Change in anti-insulin antibodies (AIAs) after 24 weeks of therapy compared to baseline value
4 secondary outcomes
FBG & PPBG
Time frame: 24 weeks
Hypoglycemia
Time frame: 24 weeks
Weight gain
Time frame: 24 weeks
Adverse events
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Results publication: PubMed 21907589Knezevic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tri Juli Edi Tarigan principal investigator
Cipto Mangunkusumo General Hospital/Faculty of Medicine Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Insulin Glargine Sansulin and Insulin Glargine Pen Injector [Lantus] in people with Diabetes Mellitus, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tri Juli Edi Tarigan, MD (62 813 1544 83293, tje_tar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04591457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.