CTRI

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CTRI Number

CTRI/2026/03/105377 [Registered on: 05/03/2026] Trial Registered Prospectively

Last Modified On:

10/09/2026

Post Graduate Thesis

Type of Trial

PMS

Type of Study

Drug

Study Design

Single Arm Study

Public Title of Study

A post-marketing study of insulin human inhalational powder in adult patients with diabetes mellitus

Scientific Title of Study

A post-marketing active surveillance of insulin human inhalational powder in adult patients with diabetes mellitus

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
CP/16/24: Version 01, dated 30.07.2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Jaideep Gogtay
Designation	Global Chief Medical Officer
Affiliation	Cipla Ltd
Address	289 Bellasis Road, Mumbai Central Mumbai MAHARASHTRA 400008 India
Phone	46185000
Fax
Email	jgogtay@cipla.com

Details of Contact Person
Scientific Query

Name	Dr Sandesh Sawant
Designation	Head Clinical Trials
Affiliation	Cipla Ltd
Address	289 Bellasis Road, Mumbai Central Mumbai MAHARASHTRA 400008 India
Phone	46185000
Fax
Email	sandesh.sawant3@cipla.com

Details of Contact Person
Public Query

Name	Rahul Namjoshi
Designation	Senior Manager
Affiliation	Cipla Ltd
Address	289 Bellasis Road, Mumbai Central Mumbai MAHARASHTRA 400008 India
Phone	46185000
Fax
Email	rahul.namjoshi@cipla.com

Source of Monetary or Material Support

Cipla Ltd 289 Bellasis Road, Mumbai Central, Mumbai, 400008, Maharashtra, India

Primary Sponsor

Name	Cipla Ltd
Address	289 Bellasis Road, Mumbai Central, Mumbai, 400008, Maharashtra, India
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 = 23
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr K V Ravi Teja	Advanced Centre for Endocrinology & Diabetes	Opp A. S. Raja Womens College, Sector 10, MVP Colony, Visakhapatnam - 530017, Andhra Pradesh Visakhapatnam ANDHRA PRADESH	8195862345 aceendocarevizag@gmail.com
Dr Nithin Reddy	AIG Hospital	Plot No 2/3/4/5, Survey No 136/1, Gachibowli, Hyderabad - 500032, Telangana, India Hyderabad TELANGANA	9869149543 nithin.kmc@gmail.com
Dr Debmalya Sanyal	Ananda Clinic	567/1 D. H. Road, Behala Manton, Kolkata – 700034, India Kolkata WEST BENGAL	9830118388 dr_debmalya@hotmail.com
Dr Arthur Joseph Asirvatham	Arthur Asirvatham Hospital	42-A, Kuruvikaran Salai, Anna Bus Stand, Madurai-625020 Madurai TAMIL NADU	9443751977 ajasirvathamresearch@yahoo.com
Dr B Likhitha	Aster Narayanadri Hospital	D.No. 9-100/1, Renigunta Rd, Tirupati, Andhra Pradesh, 517506 Chittoor ANDHRA PRADESH	9703215179 likhs.mbbs20@gmail.com
Dr Tarun Mishra	City Hospital and Research Centre	Gita Nagar, Choubey Colony, Raipur, Chattisgarh - 492001 Raipur CHHATTISGARH	9827967946 drtarunmishra@yahoo.com
Dr Venkata Rama Mohan M	Dec Health Care Hospital	Pogathota, Nellore- 524001, Andhra Pradesh, India Nellore ANDHRA PRADESH	9490463301 rammohanmddm@gmail.com
Dr Surendra Kumar Sharma	Diabetes, Thyroid and Endocrine	Centre, A-1, Madrampura, Near 4 no. ESI Hospital, Ajmer Road, Jaipur-302006 Jaipur RAJASTHAN	9829010233 sksharmacr@gmail.com
Dr Subir Swar	DM Clinic Kolkata -700055	418, Shyamnagar Road Kolkata WEST BENGAL	9874450529 drsubirswar@gmail.com
Dr Sujit Arun Chandratreya	Endocare Superspeciality Clinic	Mohiniraj Building, Gangapur Road, Near Vidya Vikas Circle, Nashik - 422013 Nashik MAHARASHTRA	9422758018 sujitchandratreya@gmail.com
Dr Parag Shah	Gujarat Endocrine Centre	AWS-3, Block-B, 518–526, Opp. Manav Mandir Road, Near Helmet Cross Roads, Memnagar, Ahmedabad – 380052, Gujarat Ahmadabad GUJARAT	7926461316 paragendo@gmail.com
Dr Kiran Kasam	Harmonyx Health Clinic	Shop no.309, Raichandani Business Bay, Dr Gandipet Main Rd, Kokapet, Hyderabad, Telangana-500075 Hyderabad TELANGANA	9910253583 drkiran567@gmail.com
Dr Mayur Agrawal	Hormone India Diabetes and Endocrine Center	E-6, 30 Area Colony, Near Sai Board, Bhopal, Madhya Pradesh – 462016, India Bhopal MADHYA PRADESH	8989893232 mayuragrawal2006@gmail.com
Dr Jothydev Kesavadev	Jothydevs Diabetes Research Centre	JDC Junction, Konkalam road, Mudavanmugal, Poojappura, Trivandrum, Kerala – 695032 Thiruvananthapuram KERALA	9895040055 jothydev@gmail.com
Dr Shehla Shaikh	K G N Diabetes and Endocrinologist Centre	9/10, 1st Floor, Patel Arcade, Nagpada Junction, Mumbai – 400008, Maharashtra Mumbai MAHARASHTRA	9820984842 drshehlas@gmail.com
Dr Lakshmi Nagendra	Magna Centre for Obesity Diabetes and Endocrinology	Manasa Shree, No: 2826 D, 1st floor, 10th cross, Adipamapa road, VV Mohalla, Mysore, 570023 Mysore KARNATAKA	9986539838 drlakshminagendra@gmail.com
Dr Ipsita Ghosh	Medicus Superspeciality Clinic	67, Rash Behari Avenue, Manohar Pukur Road, Kalighat, Kolkata, West Bengal - 700029 Kolkata WEST BENGAL	9836280826 mailipsitaghosh@gmail.com
Dr Prashanth Arun	Prof M Viswanathan Diabetes Research Centre	4, West Madha Church Street, Royapuram, Chennai 600013 Chennai TAMIL NADU	9940530630 drprashantharun@gmail.com
Dr Nilakshi Deka	Radiance Endocare	1st floor Block B Supreme Tower, (Near Silkalya), GS Road, Guwahati-781005, Assam Kamrup ASSAM	9864057897 nilsdeka@gmail.com
Dr Meenal Sehgal	Sashakt Clinic	106, 1st Floor, Sankalp Tower, Near Jharkhand Mode, Khatipura Road, Vaishali Nagar, Jaipur-302021, Rajasthan Jaipur RAJASTHAN	7340218372 meenalsehgal29@gmail.com
Dr Ritesh Kumar Agrawala	Shanti Pawan Multispecialty Care	Plot No. 1128/2658, Jaydurga Nagar, Bomikhal, Bhubaneswar-751010, Odisha Khordha ORISSA	8480500080 drriteshagr@gmail.com
Dr Supratik Bhattacharya	SKN Diabetes and Endocrine Centre	18, George Road, Naihati - Kolkata, West Bengal 743165 Kolkata WEST BENGAL	9007498749 dr_supratik@yahoo.co.uk
Dr Vinayak Harale	Supreme Clinic	Rushabh Corner, Plot 29, Shri Mhalsakant Vidyalaya Rd, Sector No.28, Pradhikaran Nigdi, Pimpri-Chinchwad, Pune-411044, Maharashtra Pune MAHARASHTRA	9766732220 vinayakharale@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 23
Name of Committee	Approval Status
Arthur Asirvatham Hospital	Approved
Asopa Ethics Committee	Approved
Aster Narayanadri Hospital	Approved
Focus Ethics Committee	Approved
Harmony Ethical Research Committee	Approved
Human Welfare Ethical Committee for Human Science and Research	Approved
IEC Sparsh Hospital and critical care private limited	Approved
Institute of Neurological Sciences	Approved
Institutional Ethics Committee - Asian Institute of Gastroenterology	Approved
Institutional Ethics Committee Charak Hospital	Approved
Institutional Ethics Committee Columbia Asia Hospital Mysore	Approved
Institutional Ethics Committee Medigene Multi Speciality Hospital Private Limited	Approved
Institutional Ethics Committee, Jothydev’s Diabetes Research Centre	Approved
OrciVita Independent Ethics Committee	Approved
OrciVita Independent Ethics Committee	Approved
OrciVita Independent Ethics Committee	Approved
OrciVita Independent Ethics Committee	Approved
PCRI Ethics Committee	Approved
Prof M Viswanathan Diabetes Research Centre	Approved
Sangini Hospital Ethics Committee	Approved
Sanjeevani Cancer Hospital IEC	Approved
Shree Institutional Ethics Committee	Approved
Vencer Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E139\|\|Other specified diabetes mellituswithout complications,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Afrezza® Insulin human inhalation powder 4U/ 8U/ 12U per cartridge with inhaler	Insulin human inhalation powder (r DNA origin) for oral inhalation use
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	1. Patients willing to sign data sharing consent before performing any procedures. 2. Patients of 18 years and above with diabetes mellitus who are prescribed Insulin human inhalation powder with inhaler as per prescribing information

ExclusionCriteria

Details

1. Known hypersensitivity to insulin or to any of the excipients.
2. Known history of bronchospasm
3. Known case of Chronic lung disease such as asthma or chronic obstructive pulmonary disease
4. History of Diabetic Ketoacidosis in last 12 months
5. Patients who smoke or who have recently stopped smoking (less than 6 months)
6. Patients unsuitable to participate as per Investigator’s discretion.
7. Female who is pregnant

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Incidence of Adverse Events Incidence of Serious Adverse Events	3 months or Day 90 6 months or Day 180

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Post Marketing Surveillance

Date of First Enrollment (India)

01/04/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

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

Diabetes as a metabolic disease has reached epidemic proportions in India. Inhaled insulin is one of the promising non-invasive candidates to address concerns with current treatment options. This is an open label, prospective, non-comparative, multicentre, post-marketing active surveillance in diabetes mellitus on the use of inhaled insulin for 6 months. Patients who are prescribed Afrezza® (Insulin human Inhalational Powder) as per prescribing information will be enrolled as per eligibility criteria in this surveillance. Safety and tolerability will be evaluated by recording adverse events during follow-up period of 6 months from the available data.