| CTRI Number |
CTRI/2022/07/044179 [Registered on: 20/07/2022] Trial Registered Prospectively |
| Last Modified On: |
13/04/2023 |
| 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 clinical study to compare the Efficacy, Safety and Tolerability of FDC of Dapagliflozin 10 mg plus Linagliptin 5mg tablets versus FDC of Dapagliflozin 10 mg plus Vildagliptin SR 100 mg Tablets in patients with Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
A Randomized, Double Blind, Active Controlled, Parallel Group, Multicentric, Phase-III clinical trial to compare the Efficacy, Safety and Tolerability of FDC of Dapagliflozin 10 mg plus Linagliptin 5mg tablets versus FDC of Dapagliflozin 10 mg plus Vildagliptin SR 100 mg Tablets in patients with Type 2 Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MLDPN/11/2021 Version 2.0 dated 11 April 2022 |
Protocol Number |
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|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjula S |
| Designation |
Sr VP Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
Dept of Medical Services, 31 Race Course Road
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
08022256323 |
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula S |
| Designation |
Sr VP Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
Dept of Medical Services, 31 Race Course Road
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
08022256323 |
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Kumar M |
| Designation |
GM - Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
Dept of Medical Services, 31 Race Course Road
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
08022256323 |
| Email |
krishna@microlabs.in |
|
|
Source of Monetary or Material Support
|
| Micro Labs Limited 31 Race Course Road Bangalore 560001 |
|
|
Primary Sponsor
|
| Name |
Micro Labs Limited |
| Address |
31 Race Course Road Bangalore 560001 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Micro Labs Limited |
31 Race Course Road Bangalore 560001 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 17 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D V Ogale |
B J Medical College and Sassoon General Hospital |
Dept of medicine, Jai Prakash Narayan Road
Pune
MAHARASHTRA |
02026128000
drogale12@gmail.com |
| Dr Mala Dharmalingam |
Bangalore Endocrinology and Diabetes Research Center |
Malleshwaram
Bangalore
KARNATAKA |
08041281998
drmaladharmalingam@gmail.com |
| Dr Ritesh Kumar |
BHU Varanasi |
Department of Endocrinology and Metabolism, Institute of medical science,Banaras Hindu University, Ajagara, Varanasi, Uttar Pradesh 221005
Varanasi
UTTAR PRADESH |
9670025320
riteshgsvm@gmail.com |
| Dr Animesh Maiti |
Calcutta Medical College, |
Dept of endocrinology, 88, College Street,
Kolkata
WEST BENGAL |
03322123853
animeshmaiti73@gmail.com |
| Dr Sisir Chakarborty |
College of Medicine and Sagore Dutta Hospital |
Dept of Endocrinology BT Road, Kamarhati, Kolkata- 700056
Kolkata
WEST BENGAL |
7003777316
chakrabortysisir@yahoo.co.in |
| Dr Parminder Singh |
Dayanand Medical College & Hospital |
Dept of Endocrinology, Civil Lines, Tagore Nagar
Ludhiana
PUNJAB |
01614688800
pam.endo@yahoo.co.in |
| Dr S K Sharma |
Diabetes, Thyroid & Endocrine Center |
Ajmer Road,
Jaipur
RAJASTHAN |
01412451946
sksharma.cr@gmail.com |
| Dr A Shanmugam |
Dr Ambedkar Institute of Diabete Govt Kilpauk Medical College & Hospital, Chennai |
822, Poonamallee High Rd,
Chennai
TAMIL NADU |
04426412979
drshanmugaa@gmail.com |
| Dr Prajapati Vipulkumar Bachubhai |
GCS Medical College, Hospital & Research Center |
Dept of medicine, Naroda Road
Ahmadabad
GUJARAT |
07966048000
prajapativipul1983@gmail.com |
| Dr K Sunil Naik |
Govt Medical College and Govt General Hospital, (Old RIMSGGH) |
Dept of medicine, shantinagar,
Srikakulam
ANDHRA PRADESH |
9912320517
rimsresearch@gmail.com |
| Dr Ved Prakash |
Indira Gandhi Institute of Medical Sciences |
Dept of Endocrinology, 2nd floor, Patna
Patna
BIHAR |
06122297631
vedprakashims@gmail.com |
| Dr Mohan Magdum |
Jehangir Clinical Development Center |
Jehangir Clinical Development Center, Jehangir hospital premises, Sasoon Road
Pune
MAHARASHTRA |
0206728800
mohanmagdum@gmail.com |
| Dr Sanjiv Maheshwari |
JLN Medical College |
Kala Bagh Ajmer
Ajmer
RAJASTHAN |
9460479888
doctor.sanjiv@gmail.com |
| Dr R Balamurugan |
Kovai Diabetes Speciality Centre & Hospital |
Dept of medicine, 15, Vivekananada Road, Ram Nagar,
Coimbatore
TAMIL NADU |
04224377732
rbmkdsc@gmail.com |
| Dr L Sreenivasamurthy |
Lifecare Hospital and Research Centre |
Dept of medicine, 2748/2152 16th E Cross Road, 8th Main, Dblock , Sahakarnagar
Bangalore
KARNATAKA |
08023631055
drlsm@lcrc.in |
| Dr Vaishal Shah |
Lifeline Multispecialty Hospital |
Vishal Complex, S.V. Road, Malad (W), Mumbai-400 064, Maharashtra
Mumbai
MAHARASHTRA |
9833803296
vshah8962@gmail.com |
| DrAshutosh sonawane |
Vakratunda Hospital Pvt Ltd, |
Raghukul Sankul, Nashik, Maharashtra -422010
Nashik
MAHARASHTRA |
8669161803
ashumarch@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Drug Trial Ethics Committee , Dayanand Medical College & Hospital, Ludhiana |
Approved |
| Ethics Committee B J Medical College and SGH B J Medical College and Sassoon General Hospital |
Approved |
| Human Welfare Ethics Committee for Human , Diabetes Thyroid and Endocrine centre Jaipur |
Approved |
| IEC, GCS Medical College, Hosp and Research Centre |
Approved |
| Institutional Ethics Commitee JLN medical college Ajmer Rajasthan |
Approved |
| Institutional Ethics Committee College of Medicine and Sagore Dutta Hospital, BT Road, Kamarhati, Kolkata- 700056 |
Approved |
| Institutional Ethics Committee for Human Research Medical College, Kolkata |
Approved |
| Institutional Ethics Committee Govt. Medical College Govt.General Hospital Srikakulam |
Approved |
| Institutional Ethics Committee Kovai Diabetes Speciality Centre and Hospital |
Approved |
| Institutional Ethics Committee, IGIMS ,Patna |
Approved |
| Institutional Ethics Committee, Institute of Medical Sciences Banaras Hindu University, Varanasi-221005, U.P., India |
Approved |
| Life Care Hospital Institutional Review Board Life Care Hospital and Research Centre, Sahakarnagar, Bangalore |
Approved |
| NavSanjeevini Hospital EThics Committee |
Approved |
| SHAH LIFELINE HOSPITAL AND HEART INSTITUTE EC |
Approved |
| SHETTYS HOSPITAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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 |
| Comparator Agent |
FDC of Dapagliflozin 10 mg plus Vildagliptin SR 100 mg Tablets |
To be taken orally once daily in the morning after breakfast for 16 weeks |
| Intervention |
Fixed dose combination of Dapagliflozin 10 mg plus Linagliptin 5 mg tablets |
To be taken orally once daily in the morning after breakfast for 16 week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aged ≥18 to ≤65 years of age of both gender with diagnosis of Type 2 diabetes mellitus.
2. Inadequate glycemic control at screening defined as HbA1c levels of ≥8.0% to ≤ 11.0%.
3. Subjects who have received stable dose of metformin IR /ER > 1500 mg/day (> 1000mg/day for subjects not tolerating) as monotherapy for at least 8 weeks prior to screening
4. Subjects with BMI less than or equal to 45.0 kg/m2 at screening
5. Female subjects of childbearing potential using adequate contraception
6. Willingness to sign written informed consent document |
|
| ExclusionCriteria |
| Details |
1. Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breast feeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study
2. Patients with Fasting Plasma Glucose (FPG) > 270 mg/dL at screening (If FPG is > 270 mg/dL at screening, FPG will be repeated within 1 week. If repeat FPG is > 270 mg/dL, patient will be excluded from the study).
3. Patients with Estimated glomerular filtration rate (eGFR) <60mL/min/1.73 m2 [using the Modification of Diet in Renal Disease(MDRD) equation] at screening.
4. Patients with clinically significant impaired hepatic function (SGOT &SGPT more than 3X the UNL and/or Total bilirubin more than 2X the UNL) at screening.
5. Subjects with History of metabolic acidosis or diabetic ketoacidosis
6. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
7. 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
8. Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests.
9. Subjects with Intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other SGLT2 inhibitors orDPP4 inhibitors
10. Any other condition that in opinion of the investigator does not justify patient’s participation in study.
11. Participation in another clinical trial within past 30 days
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in HbA1c (Glycosylated haemoglobin) from baseline at the end of week 16 |
Mean change in HbA1c (Glycosylated haemoglobin) from baseline at the end of week 16 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean change in Postprandial Blood Glucose (PPBG) from baseline to Week 16
Mean change in Fasting Blood Glucose (FBG) from baseline to Week 16
Proportion of Participants Achieving HbA1c less than7.0% from baseline to Week 16
Mean change in bodyweight - from baseline to Week 16
|
from baseline to Week 16 |
|
|
Target Sample Size
|
Total Sample Size="236"
Sample Size from India="236"
Final Enrollment numbers achieved (Total)= "229"
Final Enrollment numbers achieved (India)="229" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/08/2022 |
| Date of Study Completion (India) |
23/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
Modification(s)
|
A Randomized, Double Blind, Active Controlled, Parallel
Group, Multicentric, Phase-III clinical trial to compare the Efficacy, Safety
and Tolerability of FDC of Dapagliflozin 10 mg plus Linagliptin 5mg tablets
versus FDC of Dapagliflozin 10 mg plus
Vildagliptin SR 100 mg Tablets in patients with Type 2 Diabetes Mellitus.
In the current trial, reduction in glycemic parameters
(HbA1c, FBG, PPBG) was found to be statistically significant with Dapagliflozin
10 mg + Linagliptin 5 mg Tablets as compared to FDC of Dapagliflozin 10 mg +
Vildagliptin SR 100 mg Tablets.
|