| CTRI Number |
CTRI/2021/02/031471 [Registered on: 23/02/2021] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Phase -IV study to check the safety of fixed dose combination of dapagliflozin and saxagliptin in Indian Type 2 Diabetes Mellitus patients |
|
Scientific Title of Study
|
A prospective, multicenter, phase -IV study to assess the safety of fixed dose combination of dapagliflozin and saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D1683C00013 Version 3.0 Dated 22 Sep 2020 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Anil Bhansali |
| Designation |
National Coordinating Investigator |
| Affiliation |
Post Graduate Institute of Medical Education & Research |
| Address |
Department of Endocrinology, Room No 3027,3rd floor, Research B Block,
PGIMER, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
anilbhansaliendocrine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bharath H S |
| Designation |
Study Physician |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
N1 Block Manyatha Tech Park Manyatha Tech Park
Bangalore
KARNATAKA
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
|
| Fax |
|
| Email |
bharath.hs@astrazeneca.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Kumar |
| Designation |
Project Delivery Lead |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
N1 Block Manyatha Tech Park Manyatha Tech Park
Bangalore
KARNATAKA
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
|
| Fax |
|
| Email |
amit.kumarak@astrazeneca.com |
|
|
Source of Monetary or Material Support
|
| AstraZzeneca Pharma India Ltd |
|
|
Primary Sponsor
|
| Name |
AstraZeneca Pharma India Ltd |
| Address |
AstraZeneca Pharma India Ltd Block N1 12th Floor Manyata Embassy Business Park
Rachenahalli Outer Ring Road Bangalore-560045 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S K Wangnoo |
Apollo centre for obesity, diabetes & endocrinology |
Indraprastha Apollo Hospitals, New Delhi-44
New Delhi
DELHI |
9810113922
subhashwang@hotmail.com |
| Dr K P Singh |
Fortis Hospital |
Sector 62, Phase VIII,
Mohali SAS Nagar, Punjab 160062
Rupnagar
PUNJAB |
9815311711
drkp1292@gmail.com |
| Dr Sujoy Ghosh |
IPGMER and SSKM Hospital |
244, Acharya Jagadish Chandra Bose Road, Kolkata 700020, West Bengal
Kolkata
WEST BENGAL |
9674625823
drsujoyghosh2000@gmail.com |
| Dr Girithara Gopalakrishnan Jayaram Naidu |
KG Hospital |
A unit of K. Govindaswamy Naidu Medical Trust,
No. 5 Govt. Arts College Road,
Coimbatore – 641018, Tamil Nadu
Coimbatore
TAMIL NADU |
9443170088
drgirimd@yahoo.com |
| Dr Sandeep Kumar Gupta |
M. V. Hospital & Research Centre |
314/30 Mirza Mandi, Chowk, Lucknow, Uttar Pradesh-226003
Lucknow
UTTAR PRADESH |
8400388966
sandeepkumar.gupta@rediffmail.com |
| Dr K N Manohar |
Manipal Hospital |
98, HAL Airport road,
Bangalore, Karnataka 560017 India
Bangalore
KARNATAKA |
9845205822
drmanohar_kn@yahoo.com |
| Dr Sanjay Bhadada |
Post Graduate Institute of Medical Education & Research |
Nehru Extension Block, Ground floor, Room no-08, PGIMER, Chandigarh- 160012.
Chandigarh
CHANDIGARH |
9876602448
bhadadask@gmail.com |
| Dr Indira Pattnaik |
Sparsh Hospitals and Critical Care Limited |
Bhubaneswar751007 Odisha
Baudh
ORISSA |
9437246066
indirapattnaik@yahoo.co.in |
| Dr Faraz Farishta |
Thumbay Hospital New Life |
16-6-104 to 109, Old Kamal Theater Complex, Chaderghat Road,
Hyderabad, Telangana 500024
Hyderabad
TELANGANA |
9885035977
drfarazfarishta@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospital |
Approved |
| Institutional Ethics Committee Apollo Hospital |
Approved |
| Institutional Ethics Committee for M.V. Hospital & Research Centre |
Approved |
| Institutional Ethics Committee Fortis Hospital |
Approved |
| Institutional Ethics Committee KG Hospital |
Approved |
| Institutional Ethics Committee PGIMER |
Approved |
| Institutional Ethics Committee Thumbay Hospital New Life |
Approved |
| IPGMEandR Research oversight committee |
Approved |
| Sparsh Hospitals and Critical Care IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 and saxagliptin, fixed dose combination |
Dose: Dapagliflozin and saxagliptin 10 mg/5 mg fixed dose combination.
Duration of treatment: 24 week.
Frequency: once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg.
Route Of Administration : Orally.
|
| Comparator Agent |
Single arm - Not applicable |
Single arm - Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Provision of signed and dated, written informed consent prior to any study specific procedures according to local Indian procedure.
2. Male and female patients aged > 18 and above
3. Documented history of type 2 diabetes mellitus with HbA1c level >7.0% and ≤ 10% at screening visit
4. Patients who are on a stable dose of antidiabetic drugs (including on Metformin dose between 1000-2000mg) in the past 3 months
5. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in
conjunction with spermicide must be used. |
|
| ExclusionCriteria |
| Details |
1. Known allergies or contraindication to the contents of the IP, dapagliflozin or saxagliptin tablets.
2. Active participation in another clinical study with IP and/or investigational device
3. For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
4. Type 1 diabetes mellitus.
5. Treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors at Visit 1 or 2
6. Patients with moderate to severe renal impairment (eGFR persistently <45 mL/min/1.73 m2 by CKD-EPI formula, or end-stage renal disease (ESRD) or ‘Unstable or rapidly progressing renal disease
7. Patients with severe hepatic impairment (Child-Pugh class C)
8. History of pancreatitis or pancreatic surgery
9.Patients with a history of any malignancy
10. Patients with any of the following CV/Vascular Diseases within 3 months prior to signing the consent at enrolment, as assessed by the investigator:
• Myocardial infarction.
• Cardiac surgery or revascularization (CABG/PTCA).
• Unstable angina.
• Transient ischemic attack (TIA) or significant cerebrovascular disease.
• Unstable or previously undiagnosed arrhythmia.
11. History of heart failure
12. Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg at any visit up to randomisation
13. History of diabetic ketoacidosis
14. Any acute/chronic systemic infections
15. Recurrent urogenital infections
16. Patients at risk for volume depletion as judged by the investigator
17. Any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient or patient suspected or with confirmed poor protocol or medication compliance
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Adverse Events (AEs) including Serious adverse events (SAEs), AEs leading to discontinuation (DAE) and adverse events of special interest (volume depletion, renal events, major hypoglycaemic events, fractures, urinary/genital tract infections, diabetic ketoacidosis, amputations and hospitalization for heart failure)
• Safety laboratory values
• Electrocardiogram (ECG)
• Vital Signs (pulse and BP)
• Physical examination |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
HbA1c change at week 24 compared to baseline.
Weight change at week 24 compared to baseline.
Systolic Blood Pressure (SBP) change at week 24 compared to baseline.
FPG change at week 24 compared to baseline.
|
24 Weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "196"
Final Enrollment numbers achieved (India)="196" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
07/04/2021 |
| Date of Study Completion (India) |
08/03/2024 |
| 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
Modification(s)
|
The study was published on 03 March 2025 in Frontiers in Endocrinology. |
|
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
generate local Indian safety evidence for Dapa/Saxa 10 mg/5 mg FDC as per local
health regulatory request. The study objectives are to describe the adverse
events profile and efficacy of Dapa/Saxa fixed dose combinations in Indian T2DM
patients. Both dapagliflozin and saxagliptin are approved in India for clinical
use as individual therapy for managing T2DM patients. This study is to provide
safety data when both molecules are administered as FDC formulation. This is a
single arm study and no control group is planned.
|