| CTRI Number |
CTRI/2024/03/064004 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
11/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess safety and effectiveness of Sitagliptin, Glimepiride, and Metformin for diabetes patients in India. |
|
Scientific Title of Study
|
Post-approval, Observational study to assess safety and effectiveness of Sitagliptin+Glimepiride+Metformin in patients with diabetes on dual therapy in real-life
settings of India. |
| Trial Acronym |
(GLIMSI study) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TPL2311473 Version 00 dated 02 DEC 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kunal Jhaveri |
| Designation |
Principal Investigator |
| Affiliation |
Vishesh Clinic of Internal Medicine |
| Address |
Vishesh Clinic of Internal Medicine
312, Grand Monarch, Nr. Seema Hall, B/s Mangalya Party Plot,
100 Ft Shyamal-Prahladnagar Road, Satellite
Ahmadabad
GUJARAT
380015
India |
| Phone |
9824093938 |
| Fax |
|
| Email |
drkunaljhaveri@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnaprasad K MD |
| Designation |
General Manager - Medical Strategic Affairs (India,RoW) |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd 968 Torrent House Off Ashram Road
Terapanth Road Navrangpura
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000572 |
| Fax |
|
| Email |
krishnaprasadkorukonda@torrentpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rathish Nair PhD MBA |
| Designation |
Assistant General Manager - Medical Strategic Affairs |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd 968 Torrent House Off Ashram Road
Terapanth Road Navrangpura
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000560 |
| Fax |
|
| Email |
rathishnair@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd 968 Torrent House Off Ashram Road Terapanth Road Navrangpura
Ahmedabad Gujarat 380009 |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd |
| Address |
968 Torrent House Off Ashram Road Terapanth Road Navrangpura
Ahmedabad Gujarat 380009 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Kunal Jhaveri |
Vishesh Clinic of Internal Medicine |
312, Grand Monarch, Nr. Seema Hall, B/s Mangalya Party Plot,
100 Ft Shyamal-Prahladnagar Road, Satellite 380015
Ahmadabad
GUJARAT |
9824093938
drkunaljhaveri@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male or Female patients 18 to 65 years. Patients uncontrolled on dual therapy (Glimepiride + Metformin) or (Sitagliptin + Metformin) with HbA1c more than 7.5 & less than 8.5 %. Treatment-naïve with HbA1c more than 7.0 & less than 9.0%. Patients with FBG more than 126 mg/dl & PPG more than 200 mg/dl. Patients not taking any other OAD drugs. Patient willing to enroll for the study. |
|
| ExclusionCriteria |
| Details |
History of Type 1 diabetes.
Patients were treated with insulin within 8 weeks of screening.
Patients with renal dysfunction (crcl less than 60 ml/min) or proteinuria.
History of hypersensitivity.
Intolerance to the use of Sitagliptin, Glimepiride or Metformin.
Pregnant and lactating women.
Patients with Congestive Heart Failure, Unstable angina or ACS within past 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean change in HbA1c from baseline to 12 ± 1 weeks of treatment.
Mean change in FBG and 1 & 2-h PPG levels from baseline to 4 ± 1 weeks and 12 ± 1 weeks followup.
Mean change in weight after 12 ± 1 weeks of treatment from baseline.
Drug-Dose utilization pattern. |
From baseline to 4 ± 1 weeks and 12 ± 1 weeks followup. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Treatment adherence and compliance.
Safety assessment and tolerability.
Physician’s Global Assessment for improvement and user experience. |
From baseline to 4 ± 1 weeks and 12 ± 1 weeks followup. |
|
|
Target Sample Size
|
Total Sample Size="7000"
Sample Size from India="7000"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
22/03/2024 |
| 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="0"
Months="7"
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
|
Post-approval, Observational study to assess safety and effectiveness of Sitagliptin + Glimepiride + Metformin in patients with diabetes on dual therapy in real-life settings of India. Objective: To study the clinical impact of triple drug combination of Sitagliptin + Glimepiride + Metformin in patients with diabetes on dual therapy. Primary Endpoint: Mean change in HbA1c from baseline to 12 ± 1 weeks of treatment. Mean change in FBG and 1&2-h PPG levels from baseline to 4 ± 1 and 12 ± 1 weeks follow-up. Mean change in weight after 12 ± 1 weeks of treatment from baseline. Drug-Dose utilization pattern. Secondary Endpoints: Treatment adherence and compliance. Safety assessment and tolerability. Physician’s Global Assessment for improvement and user experience. Duration of observation: 12 weeks Criteria for evaluation: HbA1c level to be assessed at 12 ± 1 weeks. FBG and 1&2-h PPG levels to be assessed at 4± 1 and 12 ± 1 weeks. Treatment responders with HbA1c less than or equal to 7% or FBG <110 mg/dl or PPG <160 mg/dl at 12 ± 1 weeks in cases with CV risk as assessed by Q-Risk scale for Risk factor (more than or equal to 3), Comorbidities (CKD or PAD or Stroke), Family history, Current status for Micro &/or Macrovascular complications. Safety: WHO classified safety variables for Very Common (>10%), Common (>1%), Uncommon (<1%) and Rare (<0.1%) Adverse event information. |