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CTRI Number  CTRI/2023/01/049286 [Registered on: 30/01/2023] Trial Registered Prospectively
Last Modified On: 16/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Phase 3 study to evaluate the Efficacy, Safety and Tolerability of fixed dose combination of Dapagliflozin 10 mg Gliclazide 60 mg SR tablet in Patients with Type 2 Diabetes Mellitus who are inadequately controlled on Metformin Monotherapy. 
Scientific Title of Study   A Multicentric, Randomized, Prospective, Open label, Parallel Group, Active Controlled, Comparative and Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC Dapagliflozin 10 mg Gliclazide 60 mg SR tablet in Patients with Type 2 Diabetes Mellitus who are inadequately controlled on Metformin Monotherapy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
001/DAPAGLI/ERIS/2022 Version No:2.0 19th Dec 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Chandu Devanpally 
Designation  Founder and Managing Director 
Affiliation  Ardent Clinical Research Services 
Address  Office 305, 309, Level3, West Wing, Nyati Unitree, Yerawada Pune MAHARASHTRA 411006 India Pune MAHARASHTRA 411006 India

Pune
MAHARASHTRA
411006
India 
Phone  9545817447  
Fax    
Email  cdevanpally@ardent-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Chandu Devanpally 
Designation  Founder and Managing Director 
Affiliation  Ardent Clinical Research Services 
Address  Office 305, 309, Level3, West Wing, Nyati Unitree, Yerawada Pune MAHARASHTRA 411006 India Pune MAHARASHTRA 411006 India

Pune
MAHARASHTRA
411006
India 
Phone  9545817447  
Fax    
Email  cdevanpally@ardent-cro.com  
 
Details of Contact Person
Public Query  
Name  Mr Chandu Devanpally 
Designation  Founder and Managing Director 
Affiliation  Ardent Clinical Research Services 
Address  Office 305, 309, Level3, West Wing, Nyati Unitree, Yerawada Pune MAHARASHTRA 411006 India Pune MAHARASHTRA 411006 India

Pune
MAHARASHTRA
411006
India 
Phone  9545817447  
Fax    
Email  cdevanpally@ardent-cro.com  
 
Source of Monetary or Material Support  
Eris Life Sciences Limited Plot No. 142/2, Ramdas Road, Off SBR, Near Swati Bungalows, Bodakdev, Ahmedabad – 380054  
 
Primary Sponsor  
Name  Eris Life Sciences Limited 
Address  Plot No. 142/2, Ramdas Road, Off SBR, Near Swati Bungalows, Bodakdev, Ahmedabad – 380054  
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 = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sunil Kumar  Acharya Vinoba Bhava Rural Hospital   Acharya Vinoba Bhava Rural Hospital Sawangi Meghe Wardha-442001
Wardha
MAHARASHTRA 		 9850393787

sunilkumarmed@gmail.com 
Mr Suhas Erande  Akshay Hospital & Diabetic Speciality Centre  first floor Rama Vasudeva Apts Behind state of India Pune Maharashtra
Pune
MAHARASHTRA 		 9833025149
-
drsse@rediffmail.com 
Dr Animesh Maiti  Government of Bengal Medical College & Hospital  Government of Bengal Medical College and Hospital Kolkata 88 Collage Street Kolkata 700073
Kolkata
WEST BENGAL 		 9830936046

animeshmaiti73@gmail.com 
DR A S VEERAMANI  GOVERNMRNT MEDICAL COLLEGE AND GOVERNMENT GENERAL HOSPITAL  Research Wing Second floor Beside FM Ward Government General Hospital (Old RIMSGGH) Srikakulam 532001 A P India
Srikakulam
ANDHRA PRADESH 		 9703586435
-
gghsrikakulam@gmail.com 
Dr Richa Giri   GSVM Medical College  GSVM Medical College, Swaroop Nagar, Kanpur, Uttar Pradesh 208002
Kanpur Nagar
UTTAR PRADESH 		 8400331045

richa.227@rediffmail.com 
Dr Mohamed Hanifah  Mahatma Gandhi Medical College and Research Institute   Mahatma Gandhi Medical College and Research Institute Pondicherry I-Block Ground floor Cuddalore Rd ECR Pillayarkuppam Puducherry 607402
Pondicherry
PONDICHERRY 		 9751051602

hanifah4u@yahoo.com 
DR SHEJOLE VIVEK  Medipoint Hospital  Third floor clinic building Medipoint Hospitals pvt Ltd New DP road aundh pune 411007
Pune
MAHARASHTRA 		 9890847636
-
drvivek.medipoint@gmail.com 
Dr Tanuja Manohar  NKP Salve Institute of Medical Sciences & Research Centre & Lata Mangeshkar Hospital  NKP Salve Institute of Medical Sciences & Research Centre & Lata Mangeshkar Hospital Digdoh HillsHingna Road Nagpur440019
Nagpur
MAHARASHTRA 		 9822706335

tanuja.manohar9@gmail.com 
Dr Amar Raykantiwar  Shatayu Multispeciality Hospital  Shatayu Multispeciality Hospital, sr.no.27511, Times Square building, Bhatewara Nagar, Hinjewadi, Pune-41105 7
Pune
MAHARASHTRA 		 8451941050

dr.amarray26@gmail.com 
Dr Dharmendra Panchal  SMS Hospital, Ahmedabad  S.M.S Multispecialty Hospital Opposite to Akshar Complex Near Topovan Circle Ahmedabad-382424
Ahmadabad
GUJARAT 		 9879204223

panchaldrd@gmail.com 
Dr Rashmi G R  Udhbhava Hospital  Hundred feet ring road ittamadu banashakari third stage bengaluru karnataka
Bangalore
KARNATAKA 		 9632588967
-
grashmi@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Penta Med Ethics Committee Medipoint Hospit New D P Road Near Sai Heritage Aundh Pune Maharashtra  Approved 
Dr.M.K Shah Medical College & Research Centre , smt S.M.S Multispecialty Hospital  Submittted/Under Review 
Institutional Ethics Committe IHEC, College Mahatma Gandhi Medical College and Research Institute Pondicherry  Approved 
Institutional Ethics Committee for Human Research, Medical Collage & Hospital  Approved 
Institutional ethics committee government medical college & Government General Hospital(OLD RIMS Srikakulam  Approved 
Institutional Ethics Committee NKP Salve Institute of Medical Sciences   Approved 
Institutional Ethics Committee of DMIMS Datta Meghe Institute of Medical Sciences   Submittted/Under Review 
Institutional ethics Committee,GSVM Medical College  Approved 
Lifepoint Ethics Commitee  Approved 
Lifepoint Ethics Commitee  Approved 
SRI DURGAMBA INDEPENDENT ETHICS COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E110||Type 2 diabetes mellitus with hyperosmolarity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dapagliflozin 10mg SR.  Patients will be asked to consume one tablet of Dapagliflozin 10mg, SR once daily in the morning after breakfast for total 16 weeks duration. 
Intervention  FDC of Dapagliflozin 10mg, and Gliclazide 60 mg SR tablet.  Patient will be asked to consume one tablet of FDC of Dapagliflozin 10mg, and Gliclazide 60 mg SR tablets) once daily in the morning after breakfast for total 16 weeks duration. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Willing to give written informed consent to participate
2.Both genders (Male and Female) Age: 18-65 years both inclusive
3.Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study & who have a negative urine pregnancy test.
4.BMI: <35.0 kg/m2
5.HbA1c: ≥8.0% to ≤10.0%
6.In Patients with Type 2 Diabetes Mellitus who are inadequately controlled on Metformin Monotherapy ≥1000 mg per day for at least 3 months and having inadequate glycemic control
7.Patients willing to comply with the protocol requirements.
 
 
ExclusionCriteria 
Details  1.History of unstable or rapidly progressing renal disease

2.History of Type 1 diabetes mellitus

3.Patients with FPG ≥270mg/dl at screening to be excluded

4.Macroalbuminuria; defined as albumin-creatinine ratio of >500mg/g.

5.Estimated GFR <60 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation)

6.Current/chronic use of the following medication: thiazolidinedione (TZD), SU derivative, Glucagon like peptide 1 receptor agonist (GLP-1RA), (dipeptidyl peptidase 4 inhibitor) DPP-4I, SGLT-2 inhibitors, glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs). Subjects on diuretics will only be excluded when these drugs cannot be stopped for the duration of the study.

7.Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.

8.Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e., sports injury, headache, or back ache). However, no such drugs can be taken within a timeframe of 2 weeks prior to renal testing

9.Current urinary tract infection and active nephritis

10.Recent (<6 months) history of cardiovascular disease, including:

1 Acute coronary syndrome
2 Chronic heart failure (New York Heart Association grade II-IV)
3 Stroke or transient ischemic neurologic disorder

11.Complaints compatible with neurogenic bladder and/or incomplete bladder emptying (as determined by ultrasonic bladder scan)

12.Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN

13.(Unstable) thyroid disease; defined as free thyroxine (fT4) outside of laboratory reference values or change in treatment within 3 months prior to screening visit

14.History of or actual malignancy (except basal cell carcinoma) Active cancer personal history of cancer within 5 years.
History of or actual severe mental disease (Have any other condition including drug or alcohol abuse or psychiatric disorder including dementia that precludes the participant from following and completing the protocol as per judgement of the investigator.) Substance abuse (alcohol: defined as >4 units/day)

15.Allergy to any of the agents used in the study

16.Individuals who are investigator site personnel, directly affiliated with the study, or are immediate (spouse, parent, child, or sibling, whether biological or legally adopted) family of investigator site personnel directly affiliated with the study.

17.Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.

18.History of diabetic ketoacidosis or hyperosmolar nonketotic coma.

19.Severe uncontrolled hypertension defined as SBP ≥150 mmHg and/or Diastolic Blood Pressure (DBP) ≥100 mmHg

20.Inability to understand the study protocol or give informed consent

21.If participated in any other clinical trial within 6 months before the current study or concurrently enrolled/scheduled to be enrolled in any other type of medical research during the current study period.

22.Undergone a surgical procedure within 4 weeks prior to signing informed consent form.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Adjusted Mean Change from Baseline in glycated Haemoglobin A1c
(HbA1c) at Week 16.  		 Baseline to Week 16.  
 
Secondary Outcome  
Outcome  TimePoints 
1. Adjusted Mean Change from Baseline in Fasting Plasma Glucose (FPG) at Week 16.
2. Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (16 Weeks).
3. Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the study visit (16 Weeks).
4. Proportion of patients achieving a therapeutic glycaemic response, defined as HbA1c ≤ 8% at the end of the study visit (16 Weeks).



Safety Endpoints:
5. Hypoglycemic episodes during the study.
6. Changes in clinical laboratory parameters from baseline to end of the study visit (16 Weeks).
7. Number of Participants with Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 16 Week of treatment period.
 		 Baseline to Week 16.  
 
Target Sample Size   Total Sample Size="244"
Sample Size from India="244" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="244" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/02/2023 
Date of Study Completion (India) 30/11/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This trial is a phase III, prospective, randomized, Open Label, comparative, parallel group, multicenter clinical study to evaluate the efficacy, safety and tolerability of FDC Dapagliflozin 10mg Gliclazide 60mg SR with concomitant administration of Reference Product Dapagliflozin 10mg in patients with type 2 diabetes mellitus inadequately controlled on Metformin monotherapy. After confirming the inclusion/exclusion criteria the subject will be randomized and provided with study medication at randomization visit. Subjects will be provided with diary at randomization visit, which need to be brought along with in each subsequent visit till the last visit. Follow up visits will be done on week 4/day 28(±2), week 8/day 56(±2), week 12/day 84 ,Week 16 (End of Treatment) visit  to assess efficacy, safety and tolerability. 

Total number of subjects enrolled in the study are 244 each arm consist  122 subjects. 122 subjects will receive intervention and 122 subjects will receive reference.Treatment will be given to patients for 16 weeks and follow up after one week.



 
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