CTRI/2025/06/089345 [Registered on: 23/06/2025] Trial Registered Prospectively
Last Modified On:
23/06/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
A Study to evaluate effect and safety of Fixed Dose Combination of Dapagliflozin, Glimepiride and Extended Release Metformin Hydrochloride Tablets in Patients with Type 2 Diabetes Mellitus
Scientific Title of Study
A Prospective, Multicentre, Single Arm, Open-Label, Phase IV Study to Assess Efficacy and Safety of Fixed Dose Combination of Dapagliflozin, Glimepiride and Extended Release Metformin Hydrochloride Tablets in Patients with Type 2 Diabetes Mellitus
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICR/23/014, Version No. 2.0; Dated 22/MAR/2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
AVP and Head-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA
India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Supriya Sonowal
Designation
Medical Monitor-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA
India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
Supriya.Sonowal1@sunpharma.com
Details of Contact Person Public Query
Name
Digambar Tornale
Designation
Manager 2 (Operations) - India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA
India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
Digambar.Tornale@sunpharma.com
Source of Monetary or Material Support
Sun Pharma Laboratories Limited
Sun House, Plot No. 201 B/1, Western Express Highway,Goregaon (E), Mumbai 400 063, Maharashtra, India.
Primary Sponsor
Name
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA
400063
India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Sun Pharma Laboratories Limited
Sun Pharma Advanced Research Centre (SPARC), Tandalja, Vadodara, Gujarat 390012
Countries of Recruitment
India
Sites of Study
No of Sites = 14
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Prabhat Kumar Agrawal
S.N Medical college
1st floor, Department of Medicine, Moti Katra, Mantola, Agra- 282003, U.P. Agra UTTAR PRADESH
9319250485
ppagarwal120@gmail.com
Dr Harish kumar
Amrita Institute of Medical Sciences and Research Centre,
Department of Endocrinology & Diabetes, 6th floor Room no 5, G Block, AIMS- Ponekkara P.O, Kochi -682041, Kerala, India Ernakulam KERALA
9895545190
arishkumar@aims.amrita.edu
Dr Patil Virendra Ashokrao
Asian Institute of Medical Sciences
OPD No 6, Ground Floor, Department of Medicine and Endocrinology, Asian Institute of Medical Sciences, P/72, Milap nagar, MIDC, Dombivali(E), 421203 Thane MAHARASHTRA
9860567491
Viru.patil33@gmail.com
Dr M Swapna
Gandhi Hospital
In Patient Block, 2nd floor, Department of General Medicine Musheerabad Secunderabad, Telangana India- 500003 Hyderabad TELANGANA
9701859566
Srishabhaskar.sirisha@gmail.com
Dr Richa Giri
GSVM Medical College
Room no 1, Ground Floor, Postgraduate Dept of Medicine, Swaroop Nagar, Kanpur-208002, Uttar Pradesh, India. Kanpur Nagar UTTAR PRADESH
8400331045
drrichagiri.gsvm@gmail.com
Dr Anil Samaria
Jawahar Lal Nehru Medical College
Clinical Research Department, Ground Floor, Academic Building, Jawahar Lal Nehru Medical College Kala Bagh, Ajmer- 305001, Rajasthan India. Ajmer RAJASTHAN
9414008246
dr.anilsamaria@outlook.com
Dr Balamurugan Ramanathan
Kovai Diabetes Speciality Centre and Hospital
Ground floor, Department of Diabetology, No 15, Vivekanand Road, Ram Nagar, Coimbatore -641009, Tamil Nadu Coimbatore TAMIL NADU
0984224481
Balamurugan_dr@hotmail.com
Dr Sunetra Mondal
NRS Medical College and Hospital
Department of Endocrinology, 138 A.J.C, Bose Road, Raja Bazar Kolkata -700014, West Bengal India Kolkata WEST BENGAL
9475738409
Sunetra59@gmail.com
Dr Rakesh Kumar Sahay
Osmania Medical College & Osmania General Hospital
Department of Endocrinology, 2nd Floor, golden Jubilee block, Osmania Medical College & Osmania General Hospital, Afzalegunj, Hyderabad- 500012, Telangana India Hyderabad TELANGANA
9849597507
sahayrk@gmail.com
Dr Ghanekar Gayatri Amit
Shivam Hospital
Dept of Medicine, Consulting Room no 2, Ground Floor, Shivam Hospital, plot no 57, C.R.W CHS Near MIDC, water Tank, Kalyan Road, Dombivali (E) 421201 Thane MAHARASHTRA
9324493909
shivamhospitaldombivli@gmail.com
Dr Arvind Palawat
SMS Hospital
G-1, Department of Medicine Dhanvantri OPD Block SMS Hospital Jaipur-302004
Jaipur RAJASTHAN
9828025364
drpalawat@gmail.com
Dr Bharat Das
Sparsh Hospitals and Critical Care Private Limited
Department of General Medicine, Ground Floor, Room No 1, Sparsh Hospitals and Critical Care Private Limited Plot No A/407, Saheed Nagar, Bhubaneswar Khordha, Orissa-751007 India Khordha ORISSA
9938190845
Bharatdas74@gmail.com
Dr Supe Pravin Dinkar
Supe Heart and Diabetes Hospital and Research Centre
Department of Diabetology, Opp. Adhar Asharam, Near Rungta School, Gharpure Ghat, Ashok Stambh , Nashik-422002 Maharashtra India Nashik MAHARASHTRA
9405366165
drsupe1972@gmail.com
Dr Baratam Hari Kiran
Visakha Institute of Medical Sciences (VIMS)
Department of Endocrinology, Hanumanthwaka, Visakhapatnam-530040, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH
Institutional Ethics Committee Amrita Institute of Medical Sciences
Submittted/Under Review
Institutional Ethics Committee Osmania Medical College
Submittted/Under Review
Institutional Ethics Committee Sparsh Hospital
Submittted/Under Review
Institutional Ethics Committee_Gandhi Hospital
Submittted/Under Review
Institutional Ethics Committee_Jawahar Lal Nehru Medical College
Submittted/Under Review
Institutional Ethics Committee_Kovai Diabetes Speciality Centre and Hospital
Submittted/Under Review
Institutional Ethics Committee_S.N Medical College
Approved
Supe Hospital Ethics Committee
Approved
Suraksha Ethics Committee
Approved
Visakha Institute of Medical Sciences (VIMS)_Ethics Committee
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
Intervention
Dapagliflozin, Glimepiride and Extended Release Metformin Hydrochloride Tablets
Tablet to be taken once daily during breakfast or the first main meal.
10 mg/1 mg/1000 mg tablet for primary treatment period and 10 mg/2 mg/1000 mg tablet for up titration period.
Comparator Agent
Not applicable
Not applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1) Patients of either gender, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study at the time of screening.
2) Patients with diagnosis of type 2 diabetes mellitus.
Patients along with diet and exercise control, additionally on stable total daily dose of Glimepiride 1 mg and Metformin Sustained Release (SR)/Prolonged Release (PR)/Extended Release (greater than 500 mg to 1000 mg) OR on stable total daily dose Dapagliflozin 10 mg and Metformin SR/PR/Extended Release (greater than 500 mg to1000 mg) for at least 8 weeks prior to screening.
4) Patients with HbA1c greater than equal to 8.0% and less than or equal to 11% at screening and enrolment.
5) Patients with Body mass index (BMI) less than or equal to 45.0 kg/m2 at screening.
6) Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence).
ExclusionCriteria
Details
1) Patients diagnosed with type 1 diabetes, diabetes insipidus, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g., Cushing syndrome or acromegaly-associated diabetes)
2) Patients with Fasting Blood Glucose (FBG) greater than or equal to 270 mg/dL at screening (if required, measurement can be repeated and confirmed within 7 days) and enrolment
3) Patients with history of hypersensitivity to any of the study drug or to drugs of similar chemical classes (e.g., sulfonamide) or to any of its excipients.
4) Patients with administration of any therapy for diabetes, other than Metformin and Glimepiride OR Metformin and Dapagliflozin during 8 weeks prior to screening.
5) Patients with history of taking any weight loss medications within 3 months prior to enrolment.
6) Patients planning to take any anti-diabetic drugs or weight loss drugs other than study drugs or rescue medication during the study.
7)Treatment with glucocorticoids equivalent to oral prednisolone greater than or equal to 10 mg (betamethasone greater than or equal to 1.2 mg, dexamethasone greater than or equal to 1.5 mg , hydrocortisone greater than or equal to 40 mg) per day within 30 days prior to Enrolment; topical, nasal or inhaled corticosteroids are allowed.
9) Patients having significant renal (estimated Glomerular Filtration Rate (eGFR) below 45 mL/min/1.73 m2) or hepatic impairment (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] greater than 3 times the upper limit of normal [ULN]) at Screening.
10) Patients having history of acute or chronic metabolic acidosis, including diabetic ketoacidosis and lactic acidosis, pancreatitis or hyperosmolar state (including coma).
11) Patients suffering from severe urinary tract infections (e.g, urosepsis, pyelonephritis), necrotizing fasciitis of the Perineum (Fournier’s Gangrene), intravascular volume contraction and/or female genital mycotic infections prior to 6 months from screening.
12) Patients with history of myocardial infarction, coronary artery bypass surgery or percutaneous coronary intervention, stroke or transient ischemic attack prior to 6 months from screening.
13) Patients with history of sustained and clinically relevant ventricular arrhythmia.
14) Any of the following electrocardiogram (ECG) abnormalities at screening:
• Second- or third-degree atrioventricular block (AV) block without a pacemaker
• Long QT syndrome or QTc greater than 500 ms.
15) Patients having history or currently suffering with serious allergic and hypersensitivity reactions such as anaphylaxis, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome and urticaria
16) Patients with any clinically significant laboratory abnormalities/condition (e.g. immunocompromised status, malignancy, hyperthyroidism etc.) which in the opinion of Investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements.
17) Patients are on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks prior to screening.
Note: Patients who meet this criterion may be re-screened after being on a stable dose of thyroid.
18) Employee of the Sponsor, Investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees of Sponsor or the Investigator.
19) Pregnant or lactating woman
20) Patients who has participated in another investigational study within 30 days prior to screening in this study or planning to participate during the study.
Method of Generating Random Sequence
Other
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Mean change in HbA1c from Baseline at the end of Week 16
Baseline and end of Week 16
Secondary Outcome
Outcome
TimePoints
Mean change in HbA1c from Baseline at the end of Weeks 12 and 28
Baseline and end of Weeks 12 and 28
Mean change in PPBG, FBG from Baseline at the end of Weeks 12, 16 and 28
Baseline and end of Weeks 12, 16 and 28
Proportion of patients achieving HbA1c less than 7.0% at the end of Weeks 12, 16 and 28
At the end of Weeks 12, 16 and 28
Mean change in bodyweight from Baseline to end of Weeks 12, 16 and 28
Baseline and end of Weeks 12, 16 and 28
Proportion of patients receiving rescue medications by Weeks 12, 16 and 28
Weeks 12, 16 and 28
Target Sample Size
Total Sample Size="216" Sample Size from India="216" 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
Phase 4
Date of First Enrollment (India)
15/07/2025
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="0" Months="10" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
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 is a prospective, single-arm, multicentre, open-label, phase IV study. The study will be conducted at approximately 15-18 centres in India, having qualified Investigators. The study will be initiated only after the receipt of Regulatory and EC approval.
Screening Period
The screening period will be of 2 weeks. During screening period, after obtaining the written informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessments (Appendix I). Patients will be provided with screening diary at screening visit to record concomitant medications and adverse events.
Treatment Period
After confirming eligibility, patients will be enrolled into treatment period. A total of 216 patients will be enrolled in the study. In this study, total treatment period will be of 28 weeks. This 28-week treatment period will be divided into 16 weeks of treatment period 1 and 12 weeks of treatment period 2.
Note: * If a patient is withdrawn or early terminated, EOT visit should be completed. Such patients will have safety at 2 weeks after EOT.