CTRI/2022/02/040261 [Registered on: 14/02/2022] Trial Registered Prospectively
Last Modified On:
18/07/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A study to comparative non-inferiority of Liraglutide Biosimilar with Victoza in Type II Diabetes patients
Scientific Title of Study
A Prospective, Randomized, Open Label, Multi-Centre, Parallel Arm, Comparative Study with Blinded Assessment to Test the Non-inferiority of Liraglutide Biosimilar with Victoza in Patients with Type 2 Diabetes Mellitus
Trial Acronym
DIABLESS
Secondary IDs if Any
Secondary ID
Identifier
EA-CT-18-015
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Kadalmani krishnan
Designation
General Manager
Affiliation
Levim Biotech
Address
Ticel Biopark Ltd, Phase-II, 501-506
CSIR Road, Taramani Ticel Biopark Ltd, Phase-II, 501-506
CSIR Road, Taramani Chennai TAMIL NADU 600113 India
Phone
7358717219
Fax
Email
krishnan@levimbiotech.com
Details of Contact Person Scientific Query
Name
Kadalmani krishnan
Designation
General Manager
Affiliation
Levim Biotech
Address
Ticel Biopark Ltd, Phase-II, 501-506
CSIR Road, Taramani Ticel Biopark Ltd, Phase-II, 501-506
CSIR Road, Taramani Chennai TAMIL NADU 600113 India
Phone
7358717219
Fax
Email
krishnan@levimbiotech.com
Details of Contact Person Public Query
Name
Nazia Sulthana DKS
Designation
Deputy General Manager
Affiliation
Levim Biotech
Address
Ticel Biopark Ltd, Phase-II, 501-506
CSIR Road, Taramani Ticel Biopark Ltd, Phase-II, 501-506
CSIR Road, Taramani Chennai TAMIL NADU 600113 India
Phone
7358717220
Fax
Email
naziasulthana@levimbiotech.com
Source of Monetary or Material Support
Not applicable
Primary Sponsor
Name
Levim Biotech
Address
Levim Biotech LLP,
Ticel Biopark Phase II,
501-506, CSIR Road, Taramani, Chennai - 600 113
Ethics committee, S.P. Medical College, Bikaner, Pawanpuri
Approved
Institutional Ethics Committee Noorul Islam Institute of Medical Sciences, and Research Foundation, NIMS Medicity, Aralumoodu, Neyyatinkara, Trivandrum, Kerala-695123
Approved
Institutional Ethics Committee Post Graduate Institute of Medical Education and Research Room No.6006, Sixth Floor, PN Chuttani Block, Chandigarh-160012,India
Approved
Institutional Ethics Committee, Government Medical College, Kozhikode – 673008, Kerela,
Approved
Institutional Ethics Committee, KG Hospital, A Unit of K.Govindaswamy Naidu Medical Trust, No 5, Govt Arts College Road, Coimbatore - 641018
Approved
Institutional Ethics Committee, Mar Augustine Golden Jubliee Hospital (MAGJ), Mookkanoor P.O, Angamaly, Ernakulam – 683577
Approved
Institutional Ethics Committee, Nirmal Hospital Private Limited, Ring Road, Surat – 395 002, Gujarat
Approved
Institutional Ethics Committee, People Tree Hospitals, No 2, Tumkur Road, Opp. Taj Vivanta, Goraguntepalya, Yeshwanthpur, Bengaluru, Karnataka – 560022
Approved
Institutional Ethics Committee, Shubham Sudbhawana Super Speciality Hospital, B31/80, 23B-Bhogabeer Lanka, Varanasi – 221005 UP
Approved
Institutional Ethics Committee, Sir Sayajirao General Hospital (SSG Hospital) Medical College Baroda, Jail Road (lndira Avenue) , Anandpura Vadodara-390001 , Gujarat, lndia
Approved
Institutional Ethics Committee, Yashoda academy of medical education and research, Yashoda Hospitals, Behind Hari Hara Kala Bhavan, Alexander Road, Secunderabad – 500003, Telengana
Approved
Institutional Ethics Committee, Endolife Speciality Hospital Pvt, Ltd, D-NO:12-12-94, Old Club road, Kothapet, Guntur – 522001 Andhra Pradesh
Approved
Institutional Ethics Committee, Kurnool Medical College/ Govt- General Hospital,Budhawarpet, Kurnool, AP, India-518002
Approved
Institutional Ethics Committee, Osmania General Hospital, Hyderabad- 500012, Telangana, India
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Liraglutide
Liraglutide Injection 6.0 mg/ml manufactured by Levim Biotech
Dose - 1.2 mg/day via SC for the duration of 6 months
Comparator Agent
Liraglutide (Victoza)
Liraglutide Injection 6.0 mg/ml manufactured by Novo Nordisk
Dose - 1.2 mg/day via SC for the duration of 6 months
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Willing to provide the written informed consent
2. Type 2 diabetes mellitus based on the disease
diagnostic criteria provided by World Health
Organization (WHO) or American Diabetes
Association (ADA) guidelines
3. Male and female adult patients, at an age of 18-65 years, both inclusive
4. Hemoglobin level of ≥ 10 g/dL
5. Women of childbearing potential should agree to use suitable method of contraception throughout the study
6. Ability and willingness to take daily injections to abdomen, thigh or upper arm
7. Ability and willingness to adhere to the protocol requirements
ExclusionCriteria
Details
1. Type 1 diabetes mellitus
2. Known to be human immunodeficiency virus (HIV)
positive or have an acquired immunodeficiency
syndrome-related illness, or positive HIV
seropositivity at screening
3. Known active or chronic hepatitis B or hepatitis C infection, or Hepatitis B and Hepatitis C seropositivity at screening, if not related to vaccination
4. History of or ongoing cardiac dysrhythmias requiring treatment, such as uncontrolled atrial fibrillation
5. Received Liraglutide or any other GLP-1 analogue treatment in the past
6. Known hypersensitivity reaction to GLP-1 analogue or any of the product components
7. Any active malignancy within 5 years prior to
screening
8. Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardize patient’s safety or compliance with the protocol
9. Pregnant women or women planning to be pregnant or breast-feeding mothers
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Reduction in the HbA1c% from baseline compared to Victoza®
27 weeks
Secondary Outcome
Outcome
TimePoints
1. Mean changes in fasting plasma glucose (FPG) and
Post-prandial blood sugar (PPBS) from baseline to
week 24 compared to Victoza®
2. Occurrence of clinical Adverse Events (AE) and
serious AE (SAE) per System Organ Class (SOC) related to Liraglutide biosimilar or Victoza®
3. Clinical chemistry, haematology, urine analysis and other laboratory findings.
4. Incidence of hypoglycemic episodes compared to
Victoza®
27 weeks
Target Sample Size
Total Sample Size="256" Sample Size from India="256" Final Enrollment numbers achieved (Total)= "256" Final Enrollment numbers achieved (India)="256"
This study is a Prospective, Randomized, Open Label, Multi-Centre, Parallel Arm, Comparative Study with Blinded Assessment to Test the Non-inferiority of Liraglutide Biosimilar with Victoza® in Patients with Type 2 Diabetes Mellitus. The primary objective of this study is to assess the reduction in the HbA1c% from baseline profiles of Biosimilar Liraglutide injection in a pre-filled pen 6 mg / mL of Levim Biotech [Test Product (A)] with Victoza® (Liraglutide) injection in pre-filled pen 6 mg / mL [Reference Product (B)]. The secondary objective of the study is to assess the mean changes in fasting plasma glucose (FPG) and Post-prandial blood sugar (PPBS) from baseline compared to Victoza®, Occurrence of clinical Adverse Events (AE) and serious AE (SAE) per System Organ Class (SOC) related to Liraglutide biosimilar or Victoza®, Clinical chemistry, haematology, urine analysis and other laboratory findings and Incidence of hypoglycemic episodes compared to Victoza®.