CTRI/2017/02/007763 [Registered on: 02/02/2017] Trial Registered Prospectively
Last Modified On:
19/03/2019
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A multi-center study to compare the effectiveness and safety of two different insulin injectable suspensions in treatment of patients diagnosed with type 2 diabetes mellitus
Scientific Title of Study
A Prospective, Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III study to Compare the Efficacy, Safety and Immunogenicity of Premixed Human Insulin Biphasic (30% human insulin soluble injection and 70% human insulin isophane suspension) injectable suspension of MJ Biopharm Private Limited with Huminsulin® 30/70 in treatment of patients diagnosed with type 2 diabetes mellitus
MJ Biopharm Private Limited,
113, Jolly Makers Chambers No. 2,
Nariman Point, Mumbai-400 021, India
Primary Sponsor
Name
MJ Biopharm Private Limited
Address
113, Jolly Makers Chambers No. 2,
Nariman Point, Mumbai-400 021, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
JSS Medical Research India Pvt Ltd
6th Floor, Vatika Mindscapes (Tower B) Plot 12/2, Sector 27D
Faridabad – 121003, India
Countries of Recruitment
India
Sites of Study
No of Sites = 14
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Naval Vikram
All India Institute of Medical Science
Department of Medicine, AIIMS, Ansari Nagar- 110029, India South DELHI
09810007331
navalvikram@gmail.com
Dr Mahesh DM
Columbia Asia Hebbal
CAHH,Bellary road, Kirloskar Business Park- 560 026,India Bangalore KARNATAKA
08056435894
maheshendocrine@gmail.com
Dr Rajeshwari
Columbia Asia Yashwanthpur
CARHY, No #26/4 Brigarde Gateway, Malleshwaram, Beside Metro – 560055,India Bangalore KARNATAKA
08039898969
rajeswari.janakiraman@columbiaasia.com
Dr Vaishali Chetan Deshmukh
Deenanath Mangeshkar Hospital & Research Center
Department of Endocrinology,
Deenanath Mangeshkar Hospital & Research Center, Erandawane – 411 004, India
Pune MAHARASHTRA
09850811450
researchendo@gmail.com
Dr Sumitav Barua
Down town hospital
Department of Medicine, 1st Floor, Old bulding, down town hospital, G.S. Road, Dispur, Guwahati – 781 026, India Kamrup ASSAM
09864129686
summit9001@gmail.com
Dr KP Singh
Fortis Hospital
Department of Endocrinology,
Fortis Hospital, Sector - 62, Phase - VIII, Mohali – 160062, India
Chandigarh CHANDIGARH
09815311711
drkp1292@gmail.com
Dr D Anil Kumar
Gandhi Hospital
3rd floor, Department of Medicine,
Gandhi Hospital,
Bhoiguda Road, Musheerabad, Secunderabad - 500003, Telangana, India
Hyderabad ANDHRA PRADESH
09440523902
anilddrmd@gmail.com
Dr V Vivekanand
King George Hospital
Department of Endocrinology, Superspeciality Block, King George Hospital, Maharanipeta, Vizag – 530 002,India Visakhapatnam ANDHRA PRADESH
09440514756
drvivek78@gmail.com
Dr Shubha Laxmi Margekar
Lady Hardinge Medical College
Room no. 1014,
1st Floor, Old building, Lady Hardinge Medical College, Shaheed Bhagat Singh Road, Diz Area, Connaught Place- 110001, India
Central DELHI
09540364032
dr_shubhalaxmi@rediffmail.com
Dr Deepak Khandelwal
Maharaja Agrasen Hospital
Department of Endocrinology,
Maharaja Agrasen Hospital,
West Punjabi Bagh -110026, India
West DELHI
09968878561
khandelwalaiims@gmail.com
Dr Dinesh Agarwal
Marwari Hospital and Research Center
Room No. 3, First Floor, Marwari Hospital and Research Centre, ECRC-HEC Research Unit, S.J. Road, Athgaon, Guwahati – 781 001, Assam, India Kamrup ASSAM
09864061456
drdinesh944@gmail.com
Dr Sanjay Bhadada
Post Graduate Institute of Medical Education and Research (PGIMER)
Department of Endocrinology,
PGIMER, Sector - 12 – 160 012, India
Chandigarh CHANDIGARH
09876602448
bhadadash@rediffmail.com
Dr A Gopal Rao
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital
Department of Medicine,
RIMS Hospital
Research Wing, 2nd Floor, Beside Female Ward, Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital- 532001, India
Srikakulam ANDHRA PRADESH
09440122790
rimsresearch@gmail.com
Dr RP Agarwal
SP Medical College & AG Hospital
Diabetes Care and Research Centre,
SP Medical College & AG Hospital – 334001, India
Bikaner RAJASTHAN
Ethics Committee & Research Cell Marwari Hospital & Research Centre S.J Road, Athgaon, Guwahati – 781 008, Assam, India
Approved
Ethics Committee Down town hospital, Dispur, G.S. Road Guwahati-781006
Approved
Ethics Committee for Human Research, Lady Hardinge Medical College New Delhi-110001, India
Approved
Ethics Committee S.P. Medical College and AG Hospital HRM Cardiovascular Science & Research Bikaner-334001, Rajasthan
Approved
Institutional Ethics Committee Deenanath Mangeshkar Hospital and research Center Nr. Mhatre Bridge, Erandawane, Pune, Maharasthra -411004
Approved
Institutional Ethics Committee Columbia Asia Hospital, Columbia Asia Referral Hospital, Yashwanthpur. #26/4 Brigade Gateway, Malleshwaram, West Bengaluru - 560 055, Karnataka, India
Approved
Institutional Ethics Committee Columbia Asia Hospital, Columbia Asia Referral Hospital, Yashwanthpur. #26/4 Brigade Gateway, Malleshwaram, West Bengaluru - 560 055, Karnataka, India
Institutional Ethics Committee Room No. 102, 1st Floor, Old O.T. Block, All India Institute of Medical Sciences Ansari Nagar, New Delhi – 110029, India
Approved
Institutional Ethics Committee, Department of Medicine, Rajiv Gandhi Institute of Medical Science and RIMS Government General Srikakulam, Andhra Pradesh – 532 001, India
Huminsulin®30/70 100IU/mL suspension for injection
Huminsulin®30/70 100IU/mL suspension for injection (biphasic isophane insulin injection – 30 % soluble insulin and 70 % isophane insulin)
Intervention
Premix Human Insulin Biphasic 30/70, 100 IU/mL injectable suspension
Premix Human Insulin Biphasic 30/70 (30% human insulin soluble injection and 70% human insulin isophane suspension) 100 IU/mL injectable suspension manufactured by MJBPL
Patients eligible for enrolment in the study must meet all of the following criteria:
1.Male or female patients 18 to 65 years of age (both inclusive)
2.Patients who have been diagnosed with T2DM for at least 1 year prior to baseline visit
3.Patients have been receiving a stable dose of premix human insulin biphasic 30/70 (30% human insulin soluble injection and 70% human insulin isophane suspension) for at least 3 months prior to baseline visit
4.Patients with glycated haemoglobin level ≤ 11 % at screening
5.Patients willing to provide signed written informed consent
6.Patients willing to comply all aspects of the protocol
7.Ability to self-inject insulin and perform SMBG measurements. Patients whose injection is being administered by caregiver/family member (only in the case wherein the patient has fear to self-inject or does not prefer to self-inject) will be enrolled
ExclusionCriteria
Details
Patients meeting any of the following criteria must not be enrolled:
1.Patients with history or evidence of hypersensitivity to insulin or its excipients
2.Patient who has received/receiving insulin of animal origin
3.Patient with history or evidence of recurrent severe hypoglycaemia within 6 months at baseline visit
4.Patients with uncontrolled T2DM, diabetic ketoacidosis requiring hospitalization within 6 months at baseline visit
5.Patients with use of insulin pump within 6 months at baseline visit
6.Patients whose requirement for total daily dose of insulin is > 1 IU/kg
7.Patients with serum AIA level above 20 U/mL
8.Patient’s having the any of the following laboratory results at screening
a.BUN > 30 mg/dL
b.ALT/AST levels ≥ 2.5 X ULN of the normal laboratory range
c.Serum creatinine level >2.0 mg/dL
9.Patients who have positive serology for hepatitis B virus (HBV) or hepatitis C (HCV) or human immunodeficiency virus (HIV) infections
10.Patients receiving glucagon-like peptide 1 mimetics (GLP-1)
11.Patients receiving treatment with thiazolidinedione (TZD) within the last 3 months at baseline visit
12.Women of childbearing potential not willing to use acceptable method of contraception
13.Women who are pregnant or nursing mothers
14.Patients with body mass index (BMI) <18 kg/m² and ≥ 40 kg/m² at screening
15.Patients who have undergone pancreatectomy or pancreas islet transplant or renal transplant
16.Patients receiving or have received within the last year any immunomodulation medications that would possibly modify antibody generation either at the enrollment or during the course of the study
17.Patients who have received/receiving (> 14 consecutive days) glucocorticoids within 4 weeks prior to baseline visit
18.Patients with history or evidence of diabetic complications (diabetic retinopathy, diabetic neuropathy, or diabetic nephropathy), other complications related to T2DM other than those mentioned, or cardiac disorders, etc. which in the opinion of the investigator signifies patients’ ineligibility for the trial
19.Patients with alcohol or drug abuse or any other medical or surgical condition, including lifestyle (e.g. shift workers, irregularity with meal times, etc.) that in the opinion of investigator can interfere with the study protocol or affect patient’s safety in the study
20.Has participated in any other clinical trial 6 months before the study entry
Efficacy:
1.Proportion of patients with change in HbA1c
2.Change in insulin dose between the two treatment arms
3.Change in FPG and PPG
4.Change in body weight
Immunogenicity:
1.Correlation between the % change in HbA1c and % change in AIA with absolute change in total insulin dose as covariate
2.Compare the change in level of serum AIA
Safety:
1.Adverse events including clinically significant laboratory change that occur during the study
Baseline, Week 12 and Week 24
Target Sample Size
Total Sample Size="200" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "200" Final Enrollment numbers achieved (India)="200"
This is a prospective, multicenter, randomized, double-blind, parallel-group, active-controlled, Phase III study to compare the efficacy, safety and immunogenicity of premixed human insulin biphasic (30% human insulin soluble injection and 70% human insulin isophane suspension) injectable suspension of MJ Biopharm Private Limited (MJBPL) with Huminsulin®30/70 in treatment of patients diagnosed with type 2 diabetes mellitus
The Primary Objective of the study is to compare the change in glycated haemoglobin A1c (HbA1c) level from baseline to end of 12 weeks in patients diagnosed with type 2 diabetes mellitus (T2DM) receiving premix human insulin biphasic 30/70 of MJBPL versus Huminsulin® 30/70.
To compare the change in glycated haemoglobin A1c (HbA1c) level from baseline to end of 24 weeks in patients diagnosed with type 2 diabetes mellitus (T2DM) receiving premix human insulin biphasic 30/70 of MJBPL versus Huminsulin® 30/70.
The secondary objectives of the study are to evaluate the following: