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CTRI Number  CTRI/2024/07/071182 [Registered on: 24/07/2024] Trial Registered Prospectively
Last Modified On: 24/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative study of two different formulations of Insult Aspart protamine suspension in adult patients of Type 2 diabetes 
Scientific Title of Study   A Randomized, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Rapilin 30 (30% Insulin Aspart and 70% Insulin Aspart Protamine suspension) Injection with NovoMix 30 (30% Insulin Aspart and 70% Insulin Aspart Protamine suspension) Injection in Adult Patients of Type 2 Diabetes Mellitus 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CCS/INS/21/v3, Version 3 dated 26-Feb-24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajeev Chawla 
Designation  Senior Consultant Diabetologist 
Affiliation  North Delhi Diabetes and Cardiac Centre 
Address  Room No. 1, Upper ground Floor, 252, Deepali, Pitampura, New Delhi

North West
DELHI
110034
India 
Phone  01127563814  
Fax    
Email  rajeevaastikchawla@yahoo.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Mr. Rakesh Jain 
Designation  GM – Clinical Research and Biopharmaceutics 
Affiliation  Mankind Pharma Limited 
Address  Mankind Research Centre,
191 E, Sector 4 II, IMT Manesar
Gurgaon
HARYANA
122050
India 
Phone  01242873900  
Fax    
Email  rakesh.jain@mankindpharma.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Mr. Rakesh Jain 
Designation  GM – Clinical Research and Biopharmaceutics 
Affiliation  Mankind Pharma Limited 
Address  Mankind Research Centre,
191 E, Sector 4 II, IMT Manesar
Gurgaon
HARYANA
122050
India 
Phone  01242873900  
Fax    
Email  rakesh.jain@mankindpharma.com  
 
Source of Monetary or Material Support  
Mankind Pharma Limited 
 
Primary Sponsor  
Name  Mankind Pharma Limited 
Address  191 E, Sector 4 II, IMT Manesar, Haryana 122050  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rohidas T Borse  B. J. Govt. Medical College and Sassoon General Hospitals  Room No. 1, Department of Medicine, B. J. Govt. Medical College and Sassoon General Hospitals, Station Rd, Agarkar Nagar, Pune 411001
Pune
MAHARASHTRA 		 02026126868

drborser@gmail.com 
Dr Pawan Kumar Goyal  Centre for Diabetes and Internal Medicine  Room No. 01, Ground Floor, C-8/67, Sector 8, Rohini, New Delhi 110085
North West
DELHI 		 01145528585

drpkgoyal@gmail.com 
Dr Banshi Saboo  Diabetes Care and Hormone Clinic  Room No. 1, Ground Floor, Diabetes Care and Hormone Clinic, 1 and 2, Gandhi Park, near Nehru Nagar Cross Roads, Ambawadi, Ahmedabad 380015
Ahmadabad
GUJARAT 		 07926304104

banshisaboo@hotmail.com 
Dr Rahul Sahlot  Geetanjali Medical College and Hospital  Room No. 03, Hiranmagri Extension, Manwakhera NH8 Bypass, Near Eklingpura Chouraha, Udaipur 313001
Udaipur
RAJASTHAN 		 02942500001

rahulsahlot07@gmail.com 
Dr Manisha Panchal  GMERS Medical College and Hospital  Room No. 01, Hadiyol Gadhoda Road, Sabarkantha, Himmatnagar 383001
Sabar Kantha
GUJARAT 		 07923220220

drmanishapanchal@gmail.com 
Dr V Mohan  Madras Diabetes Research Foundation  Room No. 1, Ground Floor, Madras Diabetes Research Foundation, No 4, Conran Smith Road, Gopalapuram, Chennai 600086
Chennai
TAMIL NADU 		 04443968888

drmohans@diabetes.ind.in 
Dr Debasis Basu  METTA Care Clinic  Room No. 1, METTA Care Clinic, 18/18, Dover Lane, Ballygunge, Kolkata 700029
Kolkata
WEST BENGAL 		 9748044590

drdbasu@yahoo.com 
Dr Narendra Javadekar  MMF Joshi Hospital  Room No. 1, MMF Joshi Hospital, 778, Shivaji Nagar, Opposite Kamala Nehru Park, Pune 411004
Pune
MAHARASHTRA 		 02041096666

drjavadekar.research@gmail.com 
Dr Rajeev Chawla  North Delhi Diabetes and Cardiac Centre  Room No. 1, Upper ground Floor, North Delhi Diabetes and Cardiac Centre, 252, Deepali, Pitampura, New Delhi 110034
North West
DELHI 		 01127563814

rajeevaastikchawla@yahoo.com 
Dr Mohan Magdum  Poona Hospital and Research Centre  Room No. 3409, 4th Floor, Poona Hospital and Research Centre, 27, Sadashiv Peth, Pune 411030
Pune
MAHARASHTRA 		 02066096000

mohanmagdum@hotmail.com 
Dr Sanjay Saran  SMS Hospital  Room No. 43A, 4th Floor, Department of Endocrinology, Dhanvantri OPD Block, SMS Hospital, Jawahar Lal Nehru Marg, Jaipur 302004
Jaipur
RAJASTHAN 		 01412560291

drsanjaysaran@gmail.com 
Dr Indira Pattnaik  Sparsh Hospitals and Critical Care  Room No. 05, A 407, Saheed Nagar, Bhubaneswar 751007,
Khordha
ORISSA 		 0674-2540183

indirapattnaik8@gmail.com 
Dr Diwakar T N  Victoria Hospital  Room No. 67/A, 1st Floor, Department of Medicine, C Block, Victoria Hospital, Mysore Road, near City Market, New Tharagupet, Bengaluru 560002
Bangalore
KARNATAKA 		 08026706070

dr.diwakartn@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Ethics Committee  Approved 
Ethics Committee of BMCRI  Approved 
Ethics Committee Poona Hospital Research Centre  Approved 
Good Society for Ethical Research  Approved 
Good Society for Ethical Research  Approved 
Human Research Ethics Committee AARC  Approved 
Human Research Ethics Committee of Geetanjali University  Approved 
IEC Maharashtra Medical Research Society  Approved 
IEC of Madras Diabetes Research Foundation  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee Aatman Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NovoMix 30 (30% Insulin Aspart and 70% Insulin Aspart Protamine suspension Injection)  Dose 0.6, 1.0, and 1.5 unit/mg/kg/day Route of administration: Subcutaneous Duration of treatment: 24 weeks Manufactured by: M/s Novo Nordisk  
Intervention  Rapilin 30 (30% Insulin Aspart and 70% Insulin Aspart Protamine suspension Injection)  Dose 0.6, 1.0, and 1.5 unit/mg/kg/day Route of administration: Subcutaneous Duration of treatment: 24 weeks Manufactured by: M/s Gan and Lee Pharmaceuticals  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male and female patients between the ages of 18 to 65 years, both ages inclusive, who have provided written informed consent for participation in the study and willing to comply with study procedures.
2. Patients with an established diagnosis of T2DM and a duration of diabetes mellitus of at least 6 months at screening visit.
3. HbA1c between 7.5% - 10.0% (both values inclusive).
4. BMI of ≤ 40.0 kg/m2.
5. Patients treated with premix human insulin (one or more insulin injections) for at least 3 months prior to the screening visit
6. Insulin Aspart/Insulin Aspart mixes’ naïve patients
7. Current treatment with up to 3 OADs/without OADs; in case of patients on OADs unchanged dosing for at least 3 months prior to the screening visit.
8. Female patients who are not breastfeeding, and female patients of childbearing potential test negative for pregnancy, do not intend to become pregnant during the study, and agree to
continue using a reliable method of birth control.
9. Willingness and ability to self-inject insulin (2 injections daily), perform self-monitoring of blood glucose (SMBG) testing, and keep record in the patient diary. 
 
ExclusionCriteria 
Details  1. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to the day of screening.
2. Known or suspected hypersensitivity to insulin or related product(s).
3. Patients on insulin analogs (other than premix human insulin).
4. Patients with any other clinically significant disease(s) which, in the opinion of the Investigator could compromise the patient’s safety, the patient’s involvement in the study or overall interpretation of the study data.
5. Cardiovascular disease such as stroke, unstable angina pectoris, myocardial infarction, coronary arterial bypass graft or angioplasty, congestive heart failure class III or IV as per New
York Heart Association, within 6 months prior to screening.
6. Impaired liver function, defined as alanine transaminase ≥ 2.5 times upper limit of normal.
7. Patients who have less than 5 years of remission history from any malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer).
8. Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.
9. Patients who have active proliferative retinopathy or macular edema.
10. Known/screening seropositive patients of human immunodeficiency virus (HIV) or hepatitis B virus (HBV) or hepatitis C virus (HCV).
11. Women of child bearing potential who are not willing to follow a reliable and effective contraceptive measure during the course of the study and at least 1 week after the last visit. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in HbA1c value  From baseline to end of 12 weeks and from baseline to end of 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
- Change in the FPG
- Change in the post-prandial blood glucose
- Proportion of subjects who achieve target HbA1c (≤ 7%) between the treatment groups
- Safety and tolerability in terms of hypoglycemic episodes, AEs, clinical and laboratory assessments, and change in body weight
- Anti-insulin antibodies  		 From baseline to end of 12 weeks and from baseline to end of 24 weeks 
 
Target Sample Size   Total Sample Size="288"
Sample Size from India="288" 
Final Enrollment numbers achieved (Total)= "288"
Final Enrollment numbers achieved (India)="288" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 28/08/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
This study is designed to compare the efficacy, safety, and immunogenicity of Rapilin 30 (30% insulin aspart and 70% insulin aspart protamine suspension) injection with NovoMix 30 (30% insulin aspart and
70% insulin aspart protamine suspension) injection in adult patients with T2DM. This phase 3 study is of 6 months duration inclusive of the immunogenicity testing on 288 subjects. Thus, the rationale for this
study is to generate the necessary data on the efficacy, safety, and immunogenicity of Rapilin 30 (30% insulin aspart and 70% insulin aspart protamine suspension) Injection as compared to the reference
product, NovoMix 30 (30% insulin aspart and 70% insulin aspart protamine suspension) injection in adult patients with T2DM for seeking marketing authorization in India.
 
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