CTRI Number |
CTRI/2020/02/023120 [Registered on: 05/02/2020] Trial Registered Prospectively |
Last Modified On: |
08/08/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of Remogliflozin with vildagliptin in the treatment of diabetes |
Scientific Title of Study
|
Efficacy and Safety of Vildagliptin and Remogliflozin as add on therapy to Metformin in patients of Type 2 Diabetes Mellitus |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shalini Chawla |
Designation |
Director Professor |
Affiliation |
Maulana Azad Medical College |
Address |
Dept of Pharmacology
Maulana azad medical college
delhi
New Delhi DELHI 110002 India |
Phone |
|
Fax |
|
Email |
drshalinichawla@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Bhupinder singh |
Designation |
Associate Professor |
Affiliation |
Maulana Azad Medical College |
Address |
Dept of Pharmacology
Maulana azad medical college
delhi Bahadur shah zafar marg
delhi New Delhi DELHI 110002 India |
Phone |
9810785004 |
Fax |
|
Email |
drbskalra@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Bhupinder singh |
Designation |
Associate Professor |
Affiliation |
Maulana Azad Medical College |
Address |
Dept of Pharmacology
Maulana azad medical college
delhi Bahadur shah zafar marg
delhi New Delhi DELHI 110002 India |
Phone |
9810785004 |
Fax |
|
Email |
drbskalra@gmail.com |
|
Source of Monetary or Material Support
|
Maulana azad medical college, bahadur shah zafar marg, Delhi 110002 |
|
Primary Sponsor
|
Name |
Maulana azad medical college |
Address |
Bahadur shah zafar marg, Delhi 110002 |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Vikram Sharma |
lok Nayak Hospital |
Room no. 325,326, Diabetic clinic, OPD block, Lok nayak hospital Central DELHI |
8826012309
vikramsharma161@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
maulana azad medical college and associated hospitals |
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 |
Remogliflozin |
Patients will receive tablet Remogliflozin 100mg twice daily with tablet Metformin 1000-3000mg daily dosage. |
Comparator Agent |
Vildagliptin |
Will receive tablet Vildagliptin 50mg twice daily with tablet Metformin 1000-3000mg daily dosage. |
|
Inclusion Criteria
|
Age From |
35.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1.Patients with age between 35 to 70 years of all sexes.
2.Patients with diagnosis of type 2 diabetes mellitus with uncontrolled glycaemia on taking metformin alone. |
|
ExclusionCriteria |
Details |
1.Patients on any other anti-diabetic medications other than metformin.
2. Patients having hepatic dysfunction (aspartate aminotransferase/alanine aminotransferase ≥2.5 times of upper normal limit [UNL] or bilirubin > 2 times of UNL).
3.Patient with renal dysfunction (with estimated glomerular filtration rate [eGFR] as per MDRD formula < 45 ml/min/1.73 m2.
4.Patients with genitourinary tract infections.
5.Patients with lower limb cellulitis, ulcer and amputations.
6.Patients with osteoporosis and bone fractures.
7.Patients with acute pancreatitis.
8.Patients with comorbid serious illness such as tuberculosis, HIV, malignancy.
9.Patients allergic to the study medications.
10. Pregnant female patients and nursing mothers will also be excluded.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Change in Haemoglobin A1c levels from baseline to 12 weeks of treatment. |
Change in Haemoglobin A1c levels from baseline to 12 weeks of treatment. |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Change in lipid profile.
2.Change in weight.
3.Frequency of hypoglycemic episodes.
4.Safety profile of both groups. |
Change in from baseline to 12 weeks |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
28/02/2020 |
Date of Study Completion (India) |
Date Missing |
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
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Diabetes mellitus is one of the most common chronic diseases
globally responsible for increased morbidity and mortality. The global
prevalence of diabetes among adults is estimated to be 6.4%, affecting 285
million people, in 2010, and is expected to increase to 7.7%, affecting 439
million people by 2030.
The position statement of the American Diabetes Association (ADA)
and European Association for the Study of Diabetes (EASD) recommends the use of
one of six commonly used antihyperglycemic agents i.e. 1) sulfonylurea (SU), 2)
thiazolidinedione, 3) dipeptidyl peptidase-4 (DPP4) inhibitor, 4)
sodium-glucose cotransporter-2 (SGLT2) inhibitor, 5) glucagon-like peptide-1
(GLP-1) receptor agonist, or 6) basal insulin analogue, as an add-on therapy
when the individualized HbA1c target is not achieved after 3 months of
treatment with metformin alone.
Vildagliptin, a potent and selective inhibitor of dipeptidyl
peptidase-4 (DPP-4), improves glycemic control by increasing the availability
of endogenous incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent
insulinotropic polypeptide (GIP).
Remogliflozin, a selective inhibitor of sodium-glucose
cotransporter subtype 2 (SGLT2), which is to be administered as Remogliflozin
Etabonate, the prodrug for Remogliflozin. Inhibition of SGLT2
(which is selectively expressed in the proximal convoluted tubules of kidney)
leads to increased excretion of glucose in urine, resulting in reduced blood
glucose concentrations and has therapeutic benefit in T2DM. Remogliflozin
is available relatively at lower cost than the existing medications of same
class being marketed in india. Remogliflozin thus can prove to be a
cost-effective drug in treatment of type 2 diabetes mellitus in developing
country like India.
This study is proposed with the hypothesis that remogliflozin may
be non-inferior to vildagliptin in the treatment of type 2 diabetes mellitus.
|