| CTRI Number |
CTRI/2024/03/063774 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect and safety of Lobeglitazone Vs. Pioglitazone in Diabetic patients. |
|
Scientific Title of Study
|
Assessment of Clinical Efficacy and Safety of Lobeglitazone Vs. Pioglitazone in T2DM Patients- A Prospective Open Label Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs S Sarumathy |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Department of Pharmacy Practice
SRM College Of Pharmacy
SRM Institute of Science and Technology
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7010530419 |
| Fax |
|
| Email |
saruprabakar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs S Sarumathy |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Department of Pharmacy Practice
SRM College Of Pharmacy
SRM Institute of Science and Technology
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7010530419 |
| Fax |
|
| Email |
saruprabakar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr M Balamurugan |
| Designation |
PG Student |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Department of Pharmacy Practice
SRM College Of Pharmacy
SRM Institute of Science and Technology
Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
8973367139 |
| Fax |
|
| Email |
balam550166@gmail.com |
|
|
Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals, Chennai. |
| SRM College of Pharmacy, Kattankulalthur. |
| SRM Hospital and Research center, Kattankulathur
|
|
|
Primary Sponsor
|
| Name |
Balamurugan M |
| Address |
SRM Institute of Science and Technology |
| Type of Sponsor |
Other [Self] |
|
|
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 S Sarumathy |
SRM Medical College Hospital |
Department of General Medicine
SRM Institute of Science and Technology
Kattankulathur
Kattankulathur
Kancheepuram
TAMIL NADU |
7010530419
saruprabakar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lobeglitazone |
Lobeglitazone is a Novel thiazolidinedione drug to treat Type 2 Diabetes Mellitus. The dose of 0.5 mg of Lobeglitazone will be administered orally once a day for 3 months. |
| Comparator Agent |
Pioglitazone |
Pioglitazone is a standard thiazolidinedione drug for the treatment of Type 2 Diabetes Mellitus. The dose of 15 mg of Pioglitazone will be administered orally once a day for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to give informed consent form.
Patient with Body mass index 18.5 to 25 |
|
| ExclusionCriteria |
| Details |
Patients with other complications like cardiac, renal, gastrointestinal, and hematological disorders.
Patients has undergone major surgery.
A patient who has known or suspected hypersensitivity to the study drugs.
Patients with pregnancy and lactation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fasting Blood Glucose (FBG)
Post Prandial Blood Glucose(PPBG)
HbA1C |
1 month Interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lipid Profile |
3 months interval |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
15/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Assessment of efficacy and safety of Lobeglitazone vs. pioglitazone in Type 2 diabetes mellitus patient duration of 3 months. The primary outcome of FPBG, PPBG, and HbA1c and the secondary outcome of the Lipid profile will be measured. The Trial will be conducted in a Hospital setup. Additionally, the patients will be monitored for any suspected Adverse drug reaction(ADR). |