| CTRI Number |
CTRI/2019/12/022548 [Registered on: 30/12/2019] Trial Registered Prospectively |
| Last Modified On: |
02/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the effects of combination of Rosuvastatin plus Teneligliptin Tablets in diabetic patients with high lipid levels. |
|
Scientific Title of Study
|
A Phase III, Randomized, Double Blind, Parallel Group, Non-Comparative Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of FDC of Rosuvastatin plus Teneligliptin Tablets in patients suffering from Dyslipidemia associated with Type 2 Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRPL/CT/19/021 |
Protocol Number |
| Version No. 01, Dated Oct 07, 2019 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Gopal Rao |
| Designation |
Associate Professor |
| Affiliation |
Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital |
| Address |
Department of Medicine,
Rajiv Gandhi Institute of Medical Sciences
& RIMS Government General Hospital, Srikakulam-532001
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
8942279033 |
| Fax |
|
| Email |
drgopalraoa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahul Vij |
| Designation |
AGM - Regulatory Affairs |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd. Drug Regulatory Affairs,
Plot No. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar
New Delhi
DELHI
110087
India |
| Phone |
9999225948 |
| Fax |
|
| Email |
dra.domestic@synokempharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Vij |
| Designation |
AGM - Regulatory Affairs |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd. Drug Regulatory Affairs,
Plot No. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar
DELHI
110087
India |
| Phone |
9999225948 |
| Fax |
|
| Email |
dra.domestic@synokempharma.com |
|
|
Source of Monetary or Material Support
|
| Synokem Pharmaceuticals Ltd. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New
Delhi-110087, India. |
|
|
Primary Sponsor
|
| Name |
Synokem Pharmaceuticals Ltd |
| Address |
Synokem Pharmaceuticals Ltd. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New
Delhi-110087, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Brij Mohan Goyal |
Apex Hospitals Private Limited |
Apex Hospitals Pvt. Ltd.,
SP-4&6, Malviya Industrial
Area, Near Apex Circle,
Malviya Nagar, Jaipur-302017.
Jaipur
RAJASTHAN |
9413190570
drbrijmohan.goyal@gmail.com |
| Dr Pardeep Agarwal |
Chirayu Hospital |
Chirayu Hospital,
Hathoj, Kalwar Road,
Jaipur-302012.
Jaipur
RAJASTHAN |
9772846140
pradeepaga2001@yahoo.com |
| Dr Hrishikesh Bora |
Down Town Hospital Ltd |
Down Town Hospital Ltd., Dispur, G.S. Road, Guwahati-781006.
Kamrup
ASSAM |
9864044323
hris_11@yahoo.co.in |
| Dr D Anil Kumar |
Gandhi Medical College / Hospital |
Department of General Medicine,
Gandhi Medical College / Hospital, Musheerabad, Secunderabad-500003
Hyderabad
TELANGANA |
9440523902
anilddrmd@gmail.com |
| Dr A Gopal Rao |
Government Medical College & Government General Hospital (Old RIMSGGH) |
Department of Medicine,
Government Medical College & Government General
Hospital (Old RIMSGGH),
Srikakulam-532001
Srikakulam
ANDHRA PRADESH |
8942279033
drgopalraoa@gmail.com |
| Dr Kunal Sahai |
GSVM Medical College |
Post Graduate Department of Medicine, GSVM Medical College,
Swaroop Nagar, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH |
9506740977
drkunalsahai@gmail.com |
| Dr Sanjiv Maheshwari |
Jawahar Lal Nehru (J.L.N) Medical College |
Department of Medicine, Jawahar Lal Nehru (J.L.N) Medical College, Kala Bagh, Ajmer-305001.
Jaipur
RAJASTHAN |
9460479888
doctor.sanjiv@gmail.com |
| Dr Prabhat Kumar Sharma |
Maharaja Agrasen Superspeciality Hospital |
Department of Medicine,
Maharaja Agrasen Superspeciality Hospital,
Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur-302039
Jaipur
RAJASTHAN |
9983995050
agrasenhospital2003@gmail.com |
| Dr Raja Bhattacharya |
Medical College and Hospital |
Department of Medicine,
Medical College and Hospital, Kolkata, MCH Building, 4th Floor, 88 College Street, Kolkata-700073.
Kolkata
WEST BENGAL |
9477305539
rbrbhattacharya@gmail.com |
| Dr Sahid Imam Mallick |
NRS Medical College & Hospital |
Department of Medicine,
NRS Medical College & Hospital,
138, AJC Bose Hospital, Kolkata-700014
Kolkata
WEST BENGAL |
9830372665
drsahid222@gmail.com |
| Dr Vikas Reddy Maddali |
Osmania Medical College & General Hospital |
Department of Cardiology,
Osmania Medical College & General Hospital,
Afzalgunj, Hyderabad-500012
Hyderabad
TELANGANA |
9491928493
vikasreddy04@gmail.com |
| Dr Shankar Ramgouda Patil |
Prakash Institute of Medical Sciences & Research, Urun-Islampur (PIMS&R) |
Prakash Institute of Medical Sciences & Research, Urun-Islampur (PIMS&R),
Islampur-Sangali Road, Islampur, Tal-Walwa, Dist-Sangali-415409.
Sangli
MAHARASHTRA |
9822353411
prakashmc.research@gmail.com |
| Dr Vijaykumar Bhagwan Barge |
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College |
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital, Dasara Chowk, Town Hall, Bhausingji Road, Kolhapur-416002.
Kolhapur
MAHARASHTRA |
8080328480
rcsmgmc.research@gmail.com |
| Dr Sagar Vivek Redkar |
Redkar Hospital and Research Centre |
Department of Medicine,
Redkar Hospital and Research Centre,
Mumbai-Goa Highway, Oshalbag, Village-Dhargal,
Tal-Pernem, Goa-403513
North Goa
GOA |
9158592177
redkar.research@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Ethics Committee, Down Town Hospital |
Approved |
| Ethics Committee, G.S.V.M Medical College |
Submittted/Under Review |
| Institutional Ethics Committee for Human Research Medical College |
Approved |
| Institutional Ethics Committee, Apex Hospitals Private Limited |
Approved |
| Institutional Ethics Committee, Chirayu Hospital |
Approved |
| Institutional Ethics Committee, Gandhi Medical College/Gandhi Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Government Medical College & Government General Hospital (Old RIMS) |
Approved |
| Institutional Ethics Committee, Jawahar Lal Nehru Medical College |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital |
Approved |
| Institutional Ethics Committee, Osmania Medical College |
Approved |
| Kolhapur Institutional Ethics Committee 2 (RCSMGMCIEC2) |
Approved |
| NRS Ethics Committee, NRS Medical College & Hospital |
Submittted/Under Review |
| Prakash Medical College Institutional Ethics Committee |
Approved |
| Redkar Hospital Institutional Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Rosuvastatin 10 mg plus Teneligliptin 20 mg Tablets |
One tablet once a day orally in the morning after breakfast every day for 84 days (12 weeks) |
| Intervention |
FDC of Rosuvastatin 20 mg plus Teneligliptin 20 mg Tablets |
One tablet once a day orally in the morning after breakfast every day for 84 days (12 weeks) |
| Intervention |
FDC of Rosuvastatin 5 mg plus Teneligliptin 20 mg Tablets |
One tablet once a day orally in
the morning after breakfast
every day for 84 days (12
weeks) |
| Comparator Agent |
No Comparator |
NIL |
|
|
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 years (both inclusive).
2. Patient diagnosed with Dyslipidemia and Type 2 diabetes defined as: LDL-C ≥ 100 mg/dl and ≤ 250 mg/dl & HbA1c Levels ≥ 7% and ≤ 8.5%.
3. Patients who had receiving a stable dose of Metformin (≥ 1000 mg /day) for at least 3 months prior to screening.
4. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
5. Patients willing to comply with the protocol requirements.
|
|
| ExclusionCriteria |
| Details |
1. Any known contraindications to Rosuvastatin or Teneligliptin or related class of drugs.
2. Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
3. Patients with known case of type 1 diabetes mellitus.
4. Patients with glycosylated hemoglobin (HbA1c) >8.5%.
5. Patients with Body mass index (BMI) higher than 40 kg/m2.
6. Patients with clinically significant impaired hepatic function [SGOT & SGPT more than 2.5X the UNL and/or Total bilirubin more than 1.5X the UNL].
7. Patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2.
8. Patients with the history of severe heart disease (angioplasty, stent placement, bypass surgery, myocardial infarction, unstable angina pectoris, New York Heart Association class III, IV congestive heart failure, or ventricular arrhythmia within 6 months before screening).
9. Patients with known cases of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy.
10. Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
11. Females who are not ready to use acceptable contraceptive methods during the course of study.
12. Patients with known case of clinically significant cerebrovascular disease, cardiovascular disease, gastric dysfunction, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension or other medical illness that may affect patient safety or difficult to evaluate the efficacy of the product.
13. Patients who have participated in any clinical trial in the past 3 months.
14. Patients who are known cases of HIV, Hepatitis B or Hepatitis C.
15. Patients who have a recent history or who are currently known to abuse alcohol or drugs.
16. Patients with medical history of Oncological Conditions since last 5 years.
17. Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
18. Suspected inability or unwillingness to comply with the study procedures.
19. Any other condition that in the opinion of the Investigator that does not justify the patient’s participation in the study.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean change in Low-Density Lipoprotein (LDL-C) from baseline to end of the study.
2. Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study.
|
For LDL-C - At Week 4, Week 8 and Week 12
For HbA1c - At Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in fasting plasma glucose (FPG) & 2-hr post prandial glucose (PPG) from baseline to end of the study. |
At Week 4, Week 8 and Week 12 |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "252"
Final Enrollment numbers achieved (India)="252" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/12/2019 |
| Date of Study Completion (India) |
22/02/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
“A Phase III, Randomized, Double Blind, Parallel
Group, Non-Comparative Clinical Trial to Evaluate the Efficacy, Safety and
Tolerability of FDC of Rosuvastatin + Teneligliptin Tablets in patients
suffering from Dyslipidemia associated with Type 2 Diabetes Mellitus.â€
Primary
objective:
To evaluate the efficacy of FDC of Rosuvastatin + Teneligliptin Tablets
in patients suffering from Dyslipidemia associated with Type 2 Diabetes
Mellitus.
Secondary
objective:
To evaluate the safety and tolerability of FDC of Rosuvastatin + Teneligliptin Tablets
in patients suffering from Dyslipidemia associated with Type 2 Diabetes
Mellitus.
Patients who are
willing and able to participate in the study will sign and date the Informed
Consent Form on the day of screening / baseline visit (Visit 1). During this
screening period, patients who are willing to give consent will be evaluated
for all the eligibility criteria. Eligible patients aged between 18 to 65 years
(both inclusive) and fulfilling all inclusion criteria and none of the
exclusion criteria will be considered for the study.
Patients will be
assigned to either of the three arms i.e. Arm A or Arm B or Arm C consisting of
FDC of Rosuvastatin 5 mg + Teneligliptin 20 mg Tablets or FDC of Rosuvastatin
10 mg + Teneligliptin 20 mg Tablets or FDC of Rosuvastatin 20 mg +
Teneligliptin 20 mg Tablets. Patients will be given the study medication once
daily for 12 weeks. |