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Trial · Interventional

Status unknownPhase 3Registry data

Comparing Efficacy and Safety of CinnaGen-liraglutide Versus Victoza® in Patients With Type II Diabetes

NCTNCT03421119 (opens ClinicalTrials.gov in a new tab)Other idLIR.CIN.MK95
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 3
Enrollment
300 participants (estimated)
Sponsor
Cinnagen · Industry
Design
Randomized · Triple masking
Countries
Not stated
Start
20 Jun 2019 (estimated)
Primary completion
1 Dec 2019 (estimated)
Completion
1 Dec 2019 (estimated)
First posted
5 Feb 2018
Last update posted
6 Feb 2019
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20192020
  1. Ph 3

    Comparing Efficacy and Safety of CinnaGen-liraglutide Versus Victoza® in Patients With Type II Diabetes

    NCT03421119

    est. 20 Jun 2019 to est. 1 Dec 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Liraglutide 6 MG/ML Pen InjectorDrug
  • MetforminDrug
  • Sulfonylurea/non-sulfonylurea insulin secretagoguesDrug

Arms2

  • Experimental

    CinnaGen-liraglutide

    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.

  • Active comparator

    Victoza®

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. HbA1c

    Time frame · 26 weeks

    Registry description

    The primary outcome of this study is to assess changes in HbA1c in both treatment arms

Secondary outcomes(11)

  1. HbA1c < 7.0%

    Time frame · 26 weeks

    Registry description

    Percentages of subjects achieving HbA1c \< 7.0% is measured in both treatment arms

  2. HbA1c ≤ 6.5%

    Time frame · 26 weeks

    Registry description

    Percentages of subjects achieving HbA1c ≤ 6.5% is measured in both treatment arms

  3. Body weight

    Time frame · 26 weeks

    Registry description

    Changes in body weight is measured in both treatment arms

  4. Fasting blood sugar

    Time frame · 26 weeks

    Registry description

    Changes in FBS is measured in both treatment arms

  5. Postprandial glucose

    Time frame · 26 weeks

    Registry description

    Changes in mean PPG is measured in both treatment arms

  6. Systolic blood pressure

    Time frame · 26 weeks

    Registry description

    Changes in SBP (mmHg) is measured in both treatment arms

  7. Diastolic blood pressure

    Time frame · 26 weeks

    Registry description

    Changes in DBP (mmHg) is measured in both treatment arms

  8. Lipid profiles

    Time frame · 26 weeks

    Registry description

    Changes in Lipid profiles is measured in both treatment arms

  9. Pulse Rate

    Time frame · 26 weeks

    Registry description

    Changes in PR is measured in both treatment arms

  10. estimated Glomerular Filtration Rate

    Time frame · 26 weeks

    Registry description

    Changes in eGFR is measured in both treatment arms

  11. Liver enzymes

    Time frame · 26 weeks

    Registry description

    Changes in AST and ALT is measured in both treatment arms

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2009

8 results

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.

Nauck et al. 2009Diabetes carecited by 849

PMID 18931095PMC2606836DOI 10.2337/dc08-1355PUB-18931095

Free to read · publisher termsCC BY-NC-ND8 results
Read at sourceSee results (8)

Indexing hint: Randomized controlled trial · 2009

13 results

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).

Marre et al. 2009Diabetic medicine : a journal of the British Diabetic Associationcited by 610

PMID 19317822PMC2871176DOI 10.1111/j.1464-5491.2009.02666.xPUB-19317822

CC BY13 results
Download PDFSee results (13)

Indexing hint: Randomized controlled trial · 2009

16 results

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).

Buse et al. 2009Lancet (London, England)cited by 1,104

PMID 19515413DOI 10.1016/s0140-6736(09)60659-0PUB-19515413

Full text at the publisher16 results
Publisher pageSee results (16)

Indexing hint: Randomized controlled trial · 2009

10 results

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.

Russell-Jones et al. 2009Diabetologiacited by 614

PMID 19688338PMC2744824DOI 10.1007/s00125-009-1472-yPUB-19688338

Rights unknown10 results
Source linkSee results (10)

More studies

2 studies on this page

PubMed tag: none · 2023

Efficacy and Safety of a Biosimilar Liraglutide (Melitide®) Versus the Reference Liraglutide (Victoza®) in People with Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Noninferiority Clinical Trial.

Esteghamati et al. 2023Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 7

PMID 37707701PMC10570258DOI 10.1007/s13300-023-01462-wPUB-37707701

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Randomized controlled trial · 2009

Corrected

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).

Zinman et al. 2009Diabetes carecited by 621

PMID 19289857PMC2699702DOI 10.2337/dc08-2124PUB-19289857

Free to read · publisher termsCC BY-NC-ND
Read at sourceRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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), * 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

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