GLP-1 Peptide Atlas, by Delfa

UnknownPhase 3

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

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)

Lead sponsor

Cinnagen

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

300

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c ≤10%

Primary endpoint

•HbA1c, change

Identifiers

Registered as

NCT IDNCT03421119

Org study IDLIR.CIN.MK95

Timeline

Milestones

Study first posted2018-02-05actual

Last update posted2019-02-06actual

Study start2019-06-20estimated

Primary completion2019-12-01estimated

Study completion2019-12-01estimated

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

MASH / liver

Renal / kidney

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Body weight

Time frame:26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

HbA1c

Time frame:26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c < 7.0%

Time frame:26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c ≤ 6.5%

Time frame:26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting blood sugar

Time frame:26 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Postprandial glucose

Time frame:26 weeks

Postprandial glucose

change from baseline, improvement

MASH / liver

1 endpoint

Secondary/protocol endpoint

Liver enzymes

Time frame:26 weeks

change from baseline, improvement

Renal / kidney

1 endpoint

Secondary/protocol endpoint

estimated Glomerular Filtration Rate

Time frame:26 weeks

eGFR, change

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Systolic blood pressure

Time frame:26 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Diastolic blood pressure

Time frame:26 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Lipid profiles

Time frame:26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Pulse Rate

Time frame:26 weeks

Heart rate, change

change from baseline, improvement

Publications (6)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
Diabetes therapy : research, treatment and education of diabetes and related disorders2023 Nov (month)PMID37707701doi:10.1007/s13300-023-01462-wvia clinicaltrials gov reference derived + pubmed nct search
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.
Diabetologia2009 Oct (month)PMID19688338doi:10.1007/s00125-009-1472-yvia CT.gov background
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 (London, England)2009 Jul 4PMID19515413doi:10.1016/S0140-6736(09)60659-0via CT.gov background
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 care2009 Jul (month)PMID19289857doi:10.2337/dc08-2124via CT.gov background
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).
Diabetic medicine : a journal of the British Diabetic Association2009 Mar (month)PMID19317822doi:10.1111/j.1464-5491.2009.02666.xvia CT.gov background
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 care2009 Jan (month)PMID18931095doi:10.2337/dc08-1355via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.