Diabetes Mellitus, Type 2Phase 3NCT03421119
Comparing Efficacy and Safety of CinnaGen-liraglutide Versus Victoza® in Patients With Type II Diabetes
A Phase 3 study testing Liraglutide 6 MG/ML Pen Injector, Metformin and Sulfonylurea/non-sulfonylurea insulin secretagogues in people with Diabetes Mellitus, Type 2, run by Cinnagen.
Trial summary
The purpose of this study is to compare the efficacy and safety of liraglutide produced by CinnaGen company and Novo Nordisk liraglutide (Victoza®) in subjects with type II diabetes. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Liraglutide 6 MG/ML Pen Injector, Metformin and Sulfonylurea/non-sulfonylurea insulin secretagogues
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2019to 1 Dec 2019
- Phase
- Phase 3
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with Type 2 diabetes treated with maximum tolerable dose of two oral glucose-lowering agents (OGLAs; Metformin along with a Sulfonylurea/non-sulfonylurea insulin secretagogues) for ≥ 3 months
- 30-65 years of age
- 7.5 ≤ HbA1c < 10
- Body mass index (BMI) of 25-45 kg / m2
Who cannot join
- Lack of consent for being in the trial and not complying with 26-weeks follow-up period;
- Hypersensitivity to liraglutide or any component of the formulation (excipients include Disodium phosphate dehydrate, Propylene glycol, Phenol, Water for injection)
- Insulin treatment during the previous 3 months (except short-term treatment for intercurrent illness)
- Impaired liver function (alanine aminotransferase concentrations ≥ 2·5 times upper normal range).
- Impaired renal function (eGFR < 60 mL/min/1.73 m2),
- Uncontrolled hypertension (≥ 160/100 mmHg),
Show all 17Show fewer
- Malignancy
- Used any drugs apart from OGLAs likely to affect glucose concentrations, including androgens, hyperglycemia-associated agents, hypoglycemia-associated agents, MAO inhibitors, quinolone antibiotics, salicylates (Anti-inflammatory dose).
- Treatment with dipeptidyl peptidase 4 inhibitors (DPP4 inhibitors)
- Treatment with systemic corticosteroids
- History or family history of Medullary Thyroid Carcinoma (MTC)
- Multiple endocrine neoplasia syndrome type 2 (MEN2)
- History of pancreatic cancer and pancreatitis
- History of recent MI, uncontrolled CHF, and unstable Angina
- History or known case of severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy
- Pregnancy
- Previous exposure to exenatide or liraglutide
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase III, Randomized, Parallel, Double-blind, and Non-inferiority Clinical Trial to Compare Efficacy and Safety of CinnaGen-liraglutide to Innovator Liraglutide Product (Victoza®) in Patients With Type II Diabetes (T2D)
The purpose of this study is to compare the efficacy and safety of liraglutide produced by CinnaGen company and Novo Nordisk liraglutide (Victoza®) in subjects with type II diabetes. Patients with Type II diabetes treated with two oral glucose-lowering agents for ≥ 3 months, aged between 30 to 65 years, HbA1c equal or greater than 7.5 and lower than 10, and BMI between 25 to 45 were included in this study.
This study is a phase III, randomized, two-armed, parallel, double-blind, active-controlled, and non-inferiority clinical trial. Patients who enter the trial will be randomly allocated (1:1 ratio) to receive subcutaneous 1.8 mg daily injections of either Victoza® or CinnaGen-liraglutide. Doses of liraglutide will be up-titrated from 0.6 mg/day in the first week to 1.2 mg/day in the second, third and fourth weeks up to 1.8 mg/day from the beginning of the fifth week. Patients continue to receive 1.8 mg/day liraglutide until the end 26th week.
The primary objective of this study is to assess non-inferiority of CinnaGen-liraglutide to reference liraglutide in terms of efficacy in patients with T2D. The secondary objectives of this study are to further compare the efficacy of CinnaGen-liraglutide to reference liraglutide and to assess the safety of CinnaGen-liraglutide to reference liraglutide.
Read the detailed description
The purpose of this study is to compare the efficacy and safety of liraglutide produced by CinnaGen company with Novo Nordisk liraglutide (Victoza®) in subjects with type II diabetes. Patients with Type II diabetes treated with two oral glucose-lowering agents for ≥ 3 months, aged between 30 to 65 years, HbA1c equal or greater than 7.5 and lower than 10, and BMI between 25 to 45 will be included in this study. This study is a phase III, randomized, two-armed, parallel, double-blind, active-controlled, and non-inferiority clinical trial. Patients who enter the trial will be randomly allocated (1:1 ratio) to receive subcutaneous 1.8 mg daily injections of either Victoza® or CinnaGen-liraglutide. Doses of liraglutide will be up-titrated from 0.6 mg/day in the first week to 1.2 mg/day in the second, third and fourth weeks up to 1.8 mg/day from the beginning of the fifth week. Patients continue to receive 1.8 mg/day liraglutide until the end of 26th week.
Physical examinations and vital signs will be evaluated for patients at baseline, and at weeks 4, 8, 12 and 26 visits. Laboratory parameters will be assessed at baseline, week 12 and 26. The incidence of adverse events will be evaluated based on patients' reports, vital signs, physical examinations, and laboratory tests.
Before initiation, the trial will be reviewed by food and drug administration of Iran. The protocol, electronic case report form (eCRF), information for patients and informed consent form will be submitted to the ethics committees responsible for review and approval purposes, according to national regulatory guidelines.
In this study, no patient will be recruited without informed consent. All the informed consent forms which will be signed by the patients will have two copies so that patients can receive a copy of it.
Determination of sample size:
Group sample sizes of 120 and 120 achieve 80% power to detect non-inferiority using a one-sided, two-sample t-test with a non-inferiority margin of -0.4. The true difference between the means is assumed to be zero. The significance level (alpha) of the test is 0.025. The data are drawn from populations with standard deviations of 1.1 and considering a drop-out rate of 20% total sample size required is 300 patients.
Data Quality Assurance:
CinnaGen Company conducts clinical trials according to procedures that incorporate the ethical principles of GCP. Accurate and reliable data collection is assured by verification and cross-check of the eCRFs against the patient's records by clinical monitors, and the maintenance of a drug-dispensing log by the center.
CRO coordinators and sponsor attend the SIV (Site Initiation Visit) meetings. Protocol and GCP principles will be reviewed by coordinating investigator of each site, and also the needed information for completing eCRF forms will be explained.
Monitoring by CRO is performed in 30% and 70% of study progress and at the end of the study. In the monitoring sessions some sponsor personnel audit the process. During the monitoring process, CRO coordinator checks all eCRFs and confirms them to the source documents, and for required cases, the query form will be filled out.
The temperature of the refrigerator containing the medicines is checked and recorded by data logger which will be monitored regularly by the auditor.
CRO coordinator will verify drug accountability data and information about the proper time for patients' injections, and sponsor staff rechecks it.
After monitoring, problems are reported by monitor and auditor to the trial centers.
Blinding:
In order to prevent the influence of knowing intervention group on study results, the patients and those who assess the study outcomes will remain unaware of allocation to test- or reference-liraglutide.
For this purpose, patients and caregivers will be masked to allocated treatment by making reference and test products indiscernible by appearance. Medicines will be provided in a similar dosage form labeled with a unique code.
It should be noted that CRO personnel who enter data into eCRF and database and also the sponsoring personnel who monitor data entry are blinded. The study is double-blind and situations that might warrant breaking the code are defined in the protocol and include serious adverse events.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Liraglutide 6 MG/ML Pen Injector, Metformin, Sulfonylurea/non-sulfonylurea insulin secretagogues
- Keywords
- type 2 diabetes, liraglutide, efficacy, safety
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide 6 MG/ML Pen InjectorDrug
Also called CinnaGen-liraglutide, Victoza
Patients in each arm will receive either CinnaGen-liraglutide or Victoza®. Both products will be provided as pen-injector.
MetforminDrug
Also called Metformin Hydrochloride
Patients who were receiving metformin with maximum tolerable dose prior to study will continue to receive it during the study.
Sulfonylurea/non-sulfonylurea insulin secretagoguesDrug
Also called Sulfonylurea or non-sulfonylurea insulin secretagogues
Patients who were receiving Sulfonylurea/non-sulfonylurea insulin secretagogues with maximum tolerable dose prior to study will continue to receive it during the study.
| Study group | Role | What they receive |
|---|---|---|
| CinnaGen-liraglutide | Experimental | CinnaGen-liraglutide (Liraglutide 6 MG/ML Pen Injector by CinnaGen Company) will be administered 1.8 mg/day subcutaneously. Doses of CinnaGen-liraglutide will be up-titrated from 0.6 mg/day in the first week to 1.2 mg/day in the second, third and fourth weeks, up to 1.8 mg/day from the start of the fifth week to the end of 26th week. Patients in this group will continue to receive metformin along with a Sulfonylurea/non-sulfonylurea insulin secretagogues with maximum tolerable dose. Receives: Drug: Liraglutide 6 MG/ML Pen Injector; Drug: Metformin; Drug: Sulfonylurea/non-sulfonylurea insulin secretagogues |
| Victoza® | Active comparator | Victoza® (Liraglutide 6 MG/ML Pen Injector by Novo Nordisk Company) will be administered 1.8 mg/day subcutaneously. Doses of Victoza® will be up-titrated from 0.6 mg/day in the first week to 1.2 mg/day in the second, third and fourth weeks, up to 1.8 mg/day from the start of the fifth week to the end of 26th week. Patients in this group will continue to receive metformin along with a Sulfonylurea/non-sulfonylurea insulin secretagogues with maximum tolerable dose. Receives: Drug: Liraglutide 6 MG/ML Pen Injector; Drug: Metformin; Drug: Sulfonylurea/non-sulfonylurea insulin secretagogues |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
The primary outcome of this study is to assess changes in HbA1c in both treatment arms
Measured: 26 weeks
Secondary outcomes (11)
HbA1c < 7.0%
Percentages of subjects achieving HbA1c < 7.0% is measured in both treatment arms
Measured: 26 weeks
HbA1c ≤ 6.5%
Percentages of subjects achieving HbA1c ≤ 6.5% is measured in both treatment arms
Measured: 26 weeks
Body weight
Changes in body weight is measured in both treatment arms
Measured: 26 weeks
Fasting blood sugar
Changes in FBS is measured in both treatment arms
Measured: 26 weeks
Postprandial glucose
Changes in mean PPG is measured in both treatment arms
Measured: 26 weeks
Systolic blood pressure
Changes in SBP (mmHg) is measured in both treatment arms
Measured: 26 weeks
Diastolic blood pressure
Changes in DBP (mmHg) is measured in both treatment arms
Measured: 26 weeks
Lipid profiles
Changes in Lipid profiles is measured in both treatment arms
Measured: 26 weeks
Pulse Rate
Changes in PR is measured in both treatment arms
Measured: 26 weeks
estimated Glomerular Filtration Rate
Changes in eGFR is measured in both treatment arms
Measured: 26 weeks
Liver enzymes
Changes in AST and ALT is measured in both treatment arms
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start20 Jun 2019 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cinnagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohammad Ebrahim Khamseh, Professor, Principal investigator, Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421119
- Sponsor's protocol ID
- LIR.CIN.MK95
- Status last verified
- Feb 2019
- First submitted
- 29 Jan 2018
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, During M, Matthews DR; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009 Jan;32(1):84-90. doi: 10.2337/dc08-1355. Epub 2008 Oct 17.
PubMed 18931095Marre M, Shaw J, Brandle M, Bebakar WM, Kamaruddin NA, Strand J, Zdravkovic M, Le Thi TD, Colagiuri S; LEAD-1 SU study group. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU). Diabet Med. 2009 Mar;26(3):268-78. doi: 10.1111/j.1464-5491.2009.02666.x.
PubMed 19317822Zinman B, Gerich J, Buse JB, Lewin A, Schwartz S, Raskin P, Hale PM, Zdravkovic M, Blonde L; LEAD-4 Study Investigators. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Diabetes Care. 2009 Jul;32(7):1224-30. doi: 10.2337/dc08-2124. Epub 2009 Mar 16.
PubMed 19289857Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, Zdravkovic M, Ravn GM, Simo R; Liraglutide Effect and Action in Diabetes 5 (LEAD-5) met+SU Study Group. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Diabetologia. 2009 Oct;52(10):2046-55. doi: 10.1007/s00125-009-1472-y. Epub 2009 Aug 14.
PubMed 19688338Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, Zychma M, Blonde L; LEAD-6 Study Group. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet. 2009 Jul 4;374(9683):39-47. doi: 10.1016/S0140-6736(09)60659-0. Epub 2009 Jun 8.
PubMed 19515413Esteghamati A, Zamanzadeh M, Malek M, Khaledi M, Monavari A, Najafi L, Banazadeh Z, Malboosbaf R, Aghili R, Mahdikhah S, Ganjizadeh-Zavereh H, Kafi H, Hosseinpanah F, Khamseh ME. Efficacy and Safety of a Biosimilar Liraglutide (Melitide(R)) Versus the Reference Liraglutide (Victoza(R)) in People with Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Noninferiority Clinical Trial. Diabetes Ther. 2023 Nov;14(11):1889-1902. doi: 10.1007/s13300-023-01462-w. Epub 2023 Sep 14.
PubMed 37707701
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Parallel, Double-blind, and Non-inferiority Clinical Trial to Compare Efficacy and Safety of CinnaGen-liraglutide to Innovator Liraglutide Product (Victoza®) in Patients With Type II Diabetes (T2D)
- ClinicalTrials.gov ID
- NCT03421119
- Acronym / sponsor ID
- LIR.CIN.MK95
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- type 2 diabetes, liraglutide, efficacy, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- CinnagenIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2019 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 5 Feb 2018 (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.
The purpose of this study is to compare the efficacy and safety of liraglutide produced by CinnaGen company and Novo Nordisk liraglutide (Victoza®) in subjects with type II diabetes. Patients with Type II diabetes treated with two oral glucose-lowering agents for ≥ 3 months, aged between 30 to 65 years, HbA1c equal or greater than 7.5 and lower than 10, and BMI between 25 to 45 were included in this study.
This study is a phase III, randomized, two-armed, parallel, double-blind, active-controlled, and non-inferiority clinical trial. Patients who enter the trial will be randomly allocated (1:1 ratio) to receive subcutaneous 1.8 mg daily injections of either Victoza® or CinnaGen-liraglutide. Doses of liraglutide will be up-titrated from 0.6 mg/day in the first week to 1.2 mg/day in the second, third and fourth weeks up to 1.8 mg/day from the beginning of the fifth week. Patients continue to receive 1.8 mg/day liraglutide until the end 26th week.
The primary objective of this study is to assess non-inferiority of CinnaGen-liraglutide to reference liraglutide in terms of efficacy in patients with T2D. The secondary objectives of this study are to further compare the efficacy of CinnaGen-liraglutide to reference liraglutide and to assess the safety of CinnaGen-liraglutide to reference liraglutide.
Detailed description
The purpose of this study is to compare the efficacy and safety of liraglutide produced by CinnaGen company with Novo Nordisk liraglutide (Victoza®) in subjects with type II diabetes. Patients with Type II diabetes treated with two oral glucose-lowering agents for ≥ 3 months, aged between 30 to 65 years, HbA1c equal or greater than 7.5 and lower than 10, and BMI between 25 to 45 will be included in this study. This study is a phase III, randomized, two-armed, parallel, double-blind, active-controlled, and non-inferiority clinical trial. Patients who enter the trial will be randomly allocated (1:1 ratio) to receive subcutaneous 1.8 mg daily injections of either Victoza® or CinnaGen-liraglutide. Doses of liraglutide will be up-titrated from 0.6 mg/day in the first week to 1.2 mg/day in the second, third and fourth weeks up to 1.8 mg/day from the beginning of the fifth week. Patients continue to receive 1.8 mg/day liraglutide until the end of 26th week.
Physical examinations and vital signs will be evaluated for patients at baseline, and at weeks 4, 8, 12 and 26 visits. Laboratory parameters will be assessed at baseline, week 12 and 26. The incidence of adverse events will be evaluated based on patients' reports, vital signs, physical examinations, and laboratory tests.
Before initiation, the trial will be reviewed by food and drug administration of Iran. The protocol, electronic case report form (eCRF), information for patients and informed consent form will be submitted to the ethics committees responsible for review and approval purposes, according to national regulatory guidelines.
In this study, no patient will be recruited without informed consent. All the informed consent forms which will be signed by the patients will have two copies so that patients can receive a copy of it.
Determination of sample size:
Group sample sizes of 120 and 120 achieve 80% power to detect non-inferiority using a one-sided, two-sample t-test with a non-inferiority margin of -0.4. The true difference between the means is assumed to be zero. The significance level (alpha) of the test is 0.025. The data are drawn from populations with standard deviations of 1.1 and considering a drop-out rate of 20% total sample size required is 300 patients.
Data Quality Assurance:
CinnaGen Company conducts clinical trials according to procedures that incorporate the ethical principles of GCP. Accurate and reliable data collection is assured by verification and cross-check of the eCRFs against the patient's records by clinical monitors, and the maintenance of a drug-dispensing log by the center.
CRO coordinators and sponsor attend the SIV (Site Initiation Visit) meetings. Protocol and GCP principles will be reviewed by coordinating investigator of each site, and also the needed information for completing eCRF forms will be explained.
Monitoring by CRO is performed in 30% and 70% of study progress and at the end of the study. In the monitoring sessions some sponsor personnel audit the process. During the monitoring process, CRO coordinator checks all eCRFs and confirms them to the source documents, and for required cases, the query form will be filled out.
The temperature of the refrigerator containing the medicines is checked and recorded by data logger which will be monitored regularly by the auditor.
CRO coordinator will verify drug accountability data and information about the proper time for patients' injections, and sponsor staff rechecks it.
After monitoring, problems are reported by monitor and auditor to the trial centers.
Blinding:
In order to prevent the influence of knowing intervention group on study results, the patients and those who assess the study outcomes will remain unaware of allocation to test- or reference-liraglutide.
For this purpose, patients and caregivers will be masked to allocated treatment by making reference and test products indiscernible by appearance. Medicines will be provided in a similar dosage form labeled with a unique code.
It should be noted that CRO personnel who enter data into eCRF and database and also the sponsoring personnel who monitor data entry are blinded. The study is double-blind and situations that might warrant breaking the code are defined in the protocol and include serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CinnaGen-liraglutide | Experimental | Drug: Liraglutide 6 MG/ML Pen Injector, Drug: Metformin, Drug: Sulfonylurea/non-sulfonylurea insulin secretagoguesCinnaGen-liraglutide (Liraglutide 6 MG/ML Pen Injector by CinnaGen Company) will be administered 1.8 mg/day subcutaneously. Doses of CinnaGen-liraglutide will be up-titrated from 0.6 mg/day in the first week to 1.2 mg/day in the second, third and fourth weeks, up to 1.8 mg/day from the start of the fifth week to the end of 26th week. Patients in this group will continue to receive metformin along with a Sulfonylurea/non-sulfonylurea insulin secretagogues with maximum tolerable dose. |
| Victoza® | Active comparator | Drug: Liraglutide 6 MG/ML Pen Injector, Drug: Metformin, Drug: Sulfonylurea/non-sulfonylurea insulin secretagoguesVictoza® (Liraglutide 6 MG/ML Pen Injector by Novo Nordisk Company) will be administered 1.8 mg/day subcutaneously. Doses of Victoza® will be up-titrated from 0.6 mg/day in the first week to 1.2 mg/day in the second, third and fourth weeks, up to 1.8 mg/day from the start of the fifth week to the end of 26th week. Patients in this group will continue to receive metformin along with a Sulfonylurea/non-sulfonylurea insulin secretagogues with maximum tolerable dose. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with Type 2 diabetes treated with maximum tolerable dose of two oral glucose-lowering agents (OGLAs; Metformin along with a Sulfonylurea/non-sulfonylurea insulin secretagogues) for ≥ 3 months
- 30-65 years of age
- 7.5 ≤ HbA1c < 10
- Body mass index (BMI) of 25-45 kg / m2
Key exclusion criteria (17 listed)
- Lack of consent for being in the trial and not complying with 26-weeks follow-up period;
- Hypersensitivity to liraglutide or any component of the formulation (excipients include Disodium phosphate dehydrate, Propylene glycol, Phenol, Water for injection)
- Insulin treatment during the previous 3 months (except short-term treatment for intercurrent illness)
- Impaired liver function (alanine aminotransferase concentrations ≥ 2·5 times upper normal range).
- Impaired renal function (eGFR < 60 mL/min/1.73 m2),
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 |
|---|---|---|
| Liraglutide 6 MG/ML Pen InjectorAlso: CinnaGen-liraglutide, VictozaPatients in each arm will receive either CinnaGen-liraglutide or Victoza®. Both products will be provided as pen-injector. | Drug | CinnaGen-liraglutide, Victoza® |
| MetforminAlso: Metformin HydrochloridePatients who were receiving metformin with maximum tolerable dose prior to study will continue to receive it during the study. | Drug | CinnaGen-liraglutide, Victoza® |
| Sulfonylurea/non-sulfonylurea insulin secretagoguesAlso: Sulfonylurea or non-sulfonylurea insulin secretagoguesPatients who were receiving Sulfonylurea/non-sulfonylurea insulin secretagogues with maximum tolerable dose prior to study will continue to receive it during the study. | Drug | CinnaGen-liraglutide, Victoza® |
Primary outcome
HbA1c
Time frame: 26 weeks
The primary outcome of this study is to assess changes in HbA1c in both treatment arms
11 secondary outcomes
HbA1c < 7.0%
Time frame: 26 weeks
HbA1c ≤ 6.5%
Time frame: 26 weeks
Body weight
Time frame: 26 weeks
Fasting blood sugar
Time frame: 26 weeks
Postprandial glucose
Time frame: 26 weeks
Systolic blood pressure
Time frame: 26 weeks
Diastolic blood pressure
Time frame: 26 weeks
Lipid profiles
Time frame: 26 weeks
Pulse Rate
Time frame: 26 weeks
estimated Glomerular Filtration Rate
Time frame: 26 weeks
Liver enzymes
Time frame: 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Background: PubMed 18931095Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, During M, Matthews DR; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009 Jan;32(1):84-90. doi: 10.2337/dc08-1355. Epub 2008 Oct 17.
- Background: PubMed 19317822Marre M, Shaw J, Brandle M, Bebakar WM, Kamaruddin NA, Strand J, Zdravkovic M, Le Thi TD, Colagiuri S; LEAD-1 SU study group. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU). Diabet Med. 2009 Mar;26(3):268-78. doi: 10.1111/j.1464-5491.2009.02666.x.
- Background: PubMed 19289857Zinman B, Gerich J, Buse JB, Lewin A, Schwartz S, Raskin P, Hale PM, Zdravkovic M, Blonde L; LEAD-4 Study Investigators. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Diabetes Care. 2009 Jul;32(7):1224-30. doi: 10.2337/dc08-2124. Epub 2009 Mar 16.
- Background: PubMed 19688338Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, Zdravkovic M, Ravn GM, Simo R; Liraglutide Effect and Action in Diabetes 5 (LEAD-5) met+SU Study Group. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Diabetologia. 2009 Oct;52(10):2046-55. doi: 10.1007/s00125-009-1472-y. Epub 2009 Aug 14.
- Background: PubMed 19515413Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, Zychma M, Blonde L; LEAD-6 Study Group. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet. 2009 Jul 4;374(9683):39-47. doi: 10.1016/S0140-6736(09)60659-0. Epub 2009 Jun 8.
- Derived from this study: PubMed 37707701Esteghamati A, Zamanzadeh M, Malek M, Khaledi M, Monavari A, Najafi L, Banazadeh Z, Malboosbaf R, Aghili R, Mahdikhah S, Ganjizadeh-Zavereh H, Kafi H, Hosseinpanah F, Khamseh ME. Efficacy and Safety of a Biosimilar Liraglutide (Melitide(R)) Versus the Reference Liraglutide (Victoza(R)) in People with Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Noninferiority Clinical Trial. Diabetes Ther. 2023 Nov;14(11):1889-1902. doi: 10.1007/s13300-023-01462-w. Epub 2023 Sep 14.
- Individual participant dataSharing planned: Undecided
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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.
Mohammad Ebrahim Khamseh, Professor principal investigator
Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liraglutide 6 MG/ML Pen Injector, Metformin and Sulfonylurea/non-sulfonylurea insulin secretagogues in people with Diabetes Mellitus, Type 2, run by Cinnagen.
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 17 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 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Somayeh Amini, PharmD (00989398079606, amini.s@orchidpharmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 26 weeks). 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 NCT03421119, which also lists 6 linked publications.
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 6 Feb 2019.