| CTRI Number |
CTRI/2024/02/062299 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness and Safety of a New Diabetes Medication with Conventional Treatment in Patients with Type 2 Diabetes |
|
Scientific Title of Study
|
A Phase III, Prospective, Randomized, Open Label, Active Controlled, Parallel Group, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination of Dapagliflozin and Pioglitazone Tablets 10mg and 15mg of Eris Lifesciences Limited, India as compared to Concomitant Administration of Reference Product Forxiga 10 mg of AstraZeneca Pharma India limited., along with Pioglit® 15 mg tablets of Sun Pharma Laboratories India Ltd, in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on earlier metformin containing monotherapy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BSR/CT/019/23,Version-2, 16 SEP 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Ganesh Boddu |
| Designation |
Head- Regulatory Affairs, Clinical Research and Pharmacovigilance |
| Affiliation |
Eris Lifesciences Ltd |
| Address |
Eris Lifesciences Ltd., Plot No. 142-2, Ramdas Road, Off SBR, NearSwati Bungalows, Bodakdev. Ahmadabad, GUJARAT
Ahmadabad
GUJARAT
380054
India |
| Phone |
9182117253 |
| Fax |
|
| Email |
ganesh.boddu@erislifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Datta |
| Designation |
Managing Director |
| Affiliation |
Biosite Research Private Limited. |
| Address |
1st Floor , Ajmera Nucleus, 424C, next to Mahindra Tech Park, Shanthipura, Electronic city Phase 2.
KARNATAKA
560100
India |
| Phone |
8026667707 |
| Fax |
|
| Email |
aditi.datta@biositeindia.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Datta |
| Designation |
Managing Director |
| Affiliation |
Biosite Research Private Limited. |
| Address |
1st Floor , Ajmera Nucleus, 424C, next to Mahindra Tech Park, Shanthipura, Electronic city Phase 2.
KARNATAKA
560100
India |
| Phone |
8026667707 |
| Fax |
|
| Email |
aditi.datta@biositeindia.com |
|
|
Source of Monetary or Material Support
|
| Eris Lifesciences Ltd,
Plot No. 142/2, Ramdas Road, Off SBR, NearSwati Bungalows, Bodakdev. Ahmadabad, GUJARAT-380054. |
|
|
Primary Sponsor
|
| Name |
Eris Lifesciences Ltd |
| Address |
Plot No. 142-2, Ramdas Road, Off SBR, NearSwati Bungalows, Bodakdev. Ahmadabad, GUJARAT-380054 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Govardhan Rao |
Excel Hospital |
Department of endocrinology
1-5-56-29, Near IG Statue, Beside Bharat petroleum, Old Alwal, Secunderabad, Telangana-500010
Hyderabad
TELANGANA |
9440664042
drgovardhanmd1278@gmail.com |
| Dr K Sunil Naik |
Govt. Medical College Govt.General Hospital |
Department of endocrinology
Govt. Medical College Govt.General Hospital (Old RIMSGGH)-Srikakulam-532001
Srikakulam
ANDHRA PRADESH |
8942279033
drsunilnaikggh@gmail.com |
| Dr Shivendra Verma |
GSVM Medical College |
Department of endocrinology and Department of Medicine, Swaroop Nagar, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH |
8400331063
drshivendra@gmail.com |
| Dr Praveen Kumar N S |
K R Hospital attached to Mysore medical College and Research Institute |
Department of endocrinology
Irwin Road, Mysore-570001
Mysore
KARNATAKA |
9886341896
nspraveen02@gmail.com |
| Dr Anshul Kumar |
Maharaja Agrasen Hospital |
Department of endocrinology
Maharaja Agrasen Hospital,
West Punjabi Bagh, New Delhi-110026
New Delhi
DELHI |
9868238867
anshul.singh2910@gmail.com |
| Dr Rekha M C |
Mandya Institute of Medical Sciences |
Department of endocrinology
Mandya Institute of Medical Sciences
Mandya-571401
Mandya
KARNATAKA |
9845343736
drrekhamc@gmail.com |
| Dr Biplab Mandal |
North Bengal Medical College and Hospital |
Department of endocrinology
Susrutanagar, Siliguri, Dist. Darjeeling, West Bengal - 734012
Darjiling
WEST BENGAL |
9434255272
drbiplabmandal@gmail.com |
| Dr Mani Deepthi Dasari |
Rajalakshmi Hospital |
Department of endocrinology
21-1, Lakshmipura Main road, Vidyaranyapura Post, Bangalore-560097
Bangalore
KARNATAKA |
9849369714
manideepthi36@gmail.com |
| Dr Santosh Saklecha |
Santosh Hospital |
Department of endocrinology
6-1, Promenade Road, Behind Coles Park, Bangalore-560005
Bangalore
KARNATAKA |
9845306703
ssaklecha@gmail.com |
| Dr Amar Kant Amar |
Sri Ram Hospital and Research Centre Pvt Ltd |
Department of endocrinology
NC-IC, Lohia Nagar, Kankarbagh, Patna, Bihar-800020
Patna
BIHAR |
7903116586
dramar1508@gmail.com |
| Dr Dhruv Thakkar |
Swastik Medical and Dental Hospital |
Department of endocrinology
C-44-B, Om Shanti Gold Plus Lambha Vatva Canal, Lambha, Ahmedabad- 382405
Ahmadabad
GUJARAT |
9265386066
swastikmdhospital@gmail.com |
| Dr Sameer Agarwal |
Tulsi Hospital India Ltd |
Department of endocrinology
14-116-A, Civil Lines, Kanpur-208001
Kanpur Nagar
UTTAR PRADESH |
8175910410
agarwalsameer66@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical college |
Submittted/Under Review |
| Ethics Committee, Rajalakshmi Hospital |
Approved |
| Excel Hospital Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Approved |
| Institutional ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Govt. Medical College and Govt.General Hospital |
Submittted/Under Review |
| Mandya Hospital Institutional Ethics Committee |
Submittted/Under Review |
| Sangini Hospital Ethics Committee |
Submittted/Under Review |
| Tulsi Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Dapagliflozin 10mg + Pioglitazone 15mg Tablets |
Subjects shall be instructed to administer one tablet of test product once daily in the morning with
food for 12 weeks of treatment duration |
| Comparator Agent |
Forxiga 10mg tablets (Dapagliflozin) of AstraZeneca Pharma India Limited and Pioglit® 15 mg tablets |
Subjects shall be instructed to administer one tablet of test product or comparator product once daily in the morning with
food for 12 weeks of treatment duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or Female Patients aged between 18 to 65 both inclusive years with diagnosis of Type 2 diabetes mellitus.
2. Patients who have ongoing mono therapy - to be enrolled and continue them with dual therapy.i.e Patients with HbA1C level greater than or equal to 7.5% to 10% and who are presently on greater than or equal to 1000 mg-day Metformin for at least 3 months prior to screening
3. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening - baseline visit.
4. Patients with no abnormality on 12-lead ECG at screening - baseline visit.
5. Patient with ability to understand and provide written informed consent
form, which must have been obtained prior to screening.
6. Patients willing to comply with the protocol requirements
|
|
| ExclusionCriteria |
| Details |
1. Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.
2. Subjects with symptomatic urinary tract infection or mycotic genital infection at screening or history of a recent symptomatic infection within 4 weeks prior to screening
3. Patients with a history of metabolic acidosis or diabetic ketoacidosis.
4. Patients with the Body Mass Index (BMI) greater than or equal to 45.0 kg-m2 at screening
5. Patients with Fasting Plasma Glucose (FPG) greater-than 240 mg-dL at screening or randomization
6. Patients with Estimated glomerular filtration rate (eGFR) less-than sign 60 mL-min-1.73 m2 [using the Modification of Diet in Renal Disease (MDRD) equation] or serum creatinine level of 1.5 mg dL for male subjects and 1.4 mg-dL for female subjects at screening.
7. Patients with significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts), or cerebrovascular accident.
8. Intolerance, contraindication or potential allergy-hypersensitivity to any of the ingredients of study medication or any other SGLT2 or DPP4 inhibitors
9. Laboratory findings measured at screening:
a) Neutrophils less-than sign 2000 mm3
b) Platelets less-than sign100,000 mm3
c) Total bilirubin greater-than 1.5 X ULN
d) ALT- AST greater-than 2.5 X ULN
e) Serum amylase and-or lipase greater-than 3 X ULN
f) Any other screening laboratory value that is clinically significant in the Investigator’s opinion precluding patient’s participation in the study.
10. Patients with a history of anaemia or haemoglobinopathy and-or haemoglobin less-than sign 10 g dL for men; haemoglobin less-than sign 9 g dL for women at screening.
11. Patients with uncontrolled hypertension with sitting systolic BP greater than or equal to 160 mmHg and-or diastolic BP greater than or equal to 100 mmHg at screening.
12. Pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
13. Patients with known case of infection with hepatitis B, hepatitis C or HIV
14. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
15. Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
16. Suspected inability or unwillingness to comply with the study procedures.
17. Patient with 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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate mean change in HbA1c levels from baseline compared to end of study visit-week 16 |
Below mentioned visit and times lines
Visit 1. Screening Visit Days -7 to Day 0
Visit 2. Randomization-Baseline Visit Day 0
Visit 3. Interim Visit Week 2Day 14 ± 3 days
Visit 4. Interim Visit Week 4-Day 28 ± 3 days
Visit 5. Interim Visit Week 8-Day 56 ± 3 days
Visit 6. End of Study-Early Discontinuation Visit Week 12-Day 84 ± 3 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluate mean change in Fasting Plasma Glucos levels from baseline at the end of Week 2, 4, 8, and 12.
Evaluate mean change in 2-hour post prandial blood glucose levels from baseline at the end of Week 2, 4, 8, and 12.
Evaluate percentage of patients with HbA1c levels less-than 7.5% at end of study visit-week 12
|
Below mentioned visit and times lines
Visit 1. Screening Visit Days -7 to Day 0
Visit 2. Randomization-Baseline Visit Day 0
Visit 3. Interim Visit Week 2Day 14 ± 3 days
Visit 4. Interim Visit Week 4-Day 28 ± 3 days
Visit 5. Interim Visit Week 8-Day 56 ± 3 days
Visit 6. End of Study-Early Discontinuation Visit Week 12-Day 84 ± 3 days
|
|
|
Target Sample Size
|
Total Sample Size="184"
Sample Size from India="184"
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 3 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| 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) |
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
|
After informed consent process,
completion of all screening assessments and once all the inclusion-exclusion
criteria are met, the eligible subjects shall be enrolled into the study.
Demographics, Medical and surgical history will be recorded at screening visit.
Details of concomitant medications and adverse events if any shall be recorded
during each visit. Prior medication will be recorded during screening visit.
Physical examination (including general and systemic examinations) shall be
done during screening and each successive visit. Vital signs (like blood
pressure, pulse rate, respiratory rate, and body temperature) shall be measured
on each visit. Measurement of Body weight and BMI calculation will be performed
at each visit. Urine pregnancy test for females of childbearing potential shall
be performed during screening visit and end of study visit. Laboratory
assessments (Haematology and Biochemistry) shall be performed on screening and
end of study visit.
eGFR will be performed at
screening and end of study visit. Urine Analysis (Routine & Microscopic) and
serum electrolytes shall be performed during each visit except baseline visit.
12-Lead ECG examinations shall be performed during screening and end of study
visit. HbA1c levels shall be performed at screening and end of study visit.
TSH, T3, T4 tests will be performed at screening visit. FPG and PPBG levels
shall be performed at each successive visit. Serum amylase and lipase test will
be performed at screening and end of study visit. Patients will be provided
with glucometer and subject diary to record details about study drug
administration, rescue medication, adverse events, and hypoglycemia events.
Glucometer will be provided to patients to self-monitor their blood glucose
level twice weekly (should be at least 3 days apart) and the readings will be recorded
in patient diary. Patients will be instructed to fast for ≥ 12 hours prior to
their visit. Patients will be required to bring completed diary and glucometer
at each visit.
Diet and lifestyle modification
counselling will be given to the patients and the same shall be reinforced
during the study. Patients will be instructed to administer one tablet of test
product or comparator product once daily in the morning with food for 12 weeks
of treatment duration. Note. Stable dose of Metformin (whichever patients using
prior to screening visit) should continue throughout the study. Patients shall
complete seven scheduled clinic visits as follows. Visit 1. Screening Visit
(Days -7 to Day 0) Visit 2.
Randomization-Baseline Visit (Day 0) Visit 3. Interim Visit (Week 2-Day 14 ±3 days)
Visit 4. Interim Visit (Week 4-Day 28 ±
3 days) Visit 5. Interim Visit (Week 8-Day 56 ± 3 days) Visit 5. End of Study-Early Discontinuation
Visit (Week 12-Day 84 ± 3 days |