| CTRI Number |
CTRI/2025/08/093017 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find out if adding the medicine Pioglitazone can help control blood sugar better in Indian people with type 2 diabetes who are already taking Glimepiride and Metformin |
|
Scientific Title of Study
|
A Prospective, Open Label, Single Arm Study to Evaluate the Effectiveness of Pioglitazone as an add-on therapy in Management of Insulin Resistance in Indian T2DM Participants Uncontrolled on Optimal Dose of Glimepiride Plus Metformin |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 25-AGCR-003 Version 1.0 dated 24 Jun 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mangesh Tiwaskar |
| Designation |
Principal Investigator |
| Affiliation |
Shilpa Medical Research Centre |
| Address |
OPD Department, Shilpa Medical Research Centre, A/1, Rainbow Building, behind Maratha Bank, Save Nagar, Jaya Nagar, Avdhut Nagar, Dahisar East, Mumbai, Maharashtra 400068
Mumbai (Suburban)
MAHARASHTRA
400068
India |
| Phone |
9820067424 |
| Fax |
|
| Email |
tiwaskar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangesh Tiwaskar |
| Designation |
Principal Investigator |
| Affiliation |
Shilpa Medical Research Centre |
| Address |
Shilpa Medical Research Centre, Rainbow Apartment, E, A/1, behind Maratha Bank, Save Nagar, Jaya Nagar, Avdhut Nagar, Dahisar East, Mumbai, Maharashtra 400068
Porbandar
MAHARASHTRA
400068
India |
| Phone |
9820067424 |
| Fax |
|
| Email |
tiwaskar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangesh Shende |
| Designation |
Chief Executive Officer |
| Affiliation |
Akshar Global Clinical Research Private Limited |
| Address |
Akshar Global Clinical Research Private Limited, 1027, Iconic Shyamal, Shyamal Cross Roads, 132 Feet Ring Rd, Swinagar Society, Nehru Nagar, Shyamal, Ahmedabad, Gujarat 380015
Ahmadabad
GUJARAT
380015
India |
| Phone |
9978078056 |
| Fax |
|
| Email |
mangesh.shende@agcro.com |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Pvt Ltd, Floor 16, Godrej BKC, Plot No. C-68, BKC, Near MCA Club, Bandra (E), Mumbai-400051, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Abbott Healthcare Pvt Ltd |
| Address |
Floor 16, Godrej BKC, Plot No. C-68, BKC, Near MCA Club, Bandra (E), Mumbai-400051, Maharashtra, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Mangesh Tiwaskar |
Shilpa Medical Research Centre |
Shilpa Medical Research Centre, Rainbow Apartment, E, A/1, behind Maratha Bank, Save Nagar, Jaya Nagar, Avdhut Nagar, Dahisar East, Mumbai, Maharashtra 400068
Mumbai (Suburban)
MAHARASHTRA |
9820067424
tiwaskar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethicare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Pioglitazone 15 mg + Glimepiride 1 or 2 mg + Metformin 500 mg FDC |
Pioglitazone 15 mg + Glimepiride 1 or 2 mg + Metformin 500 mg FDC tablet will be administered once daily for 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
72.00 Year(s) |
| Gender |
Both |
| Details |
1. Men and women between the ages of 18 years and above who are diagnosed with type 2 diabetes mellitus for 6 months and above according to American Diabetes Association ADA Guidelines 2024
2. T2DM participants uncontrolled on optimal doses of Glimepiride plus Metformin with HbA1c greater than 7.5 percent and up to 10 percent at the time of screening as per the laboratory analysis
3. At least 3 months of treatment with optimal doses of Glimepiride plus Metformin
4. Participants with high HOMA IR greater than 2.9 at the time of enrollment
5. Participants willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations
6. Participants willing to provide informed consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Participant with type 1 diabetes, special types of diabetes (such as diabetes caused by pancreatic injury, Cushing syndrome or diabetes caused by acromegaly, etc.) or current use of insulin
2. Participant with a known hypersensitivity to Metformin or a Glimepiride or a Pioglitazone or any of the excipients of the product or contraindications as per prescribing information.
3. Participant who will likely require or initiate therapy with drugs that may interfere with glucose metabolism during the course of the study (e.g., glucocorticoids)
4. Any other clinically significant conditions as per the opinion of investigator
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess improvement in Insulin resistance from baseline to 6 months by addition of Pioglitazone 15 mg to optimal dose of Glimepiride 1 or 2 mg plus Metformin 500 mg in participants with uncontrolled Type 2 Diabetes Mellitus (T2DM) |
Visit 1: Screening Visit (Within 14 days)
Visit 2: Baseline Visit (Day 1)
Visit 3: Day 43 (±3) (Week 6)
Visit 4: Day 85 (±3) (Week 12)
Visit 5: Day 127 (±3) (Week 18)
Visit 6: Day 169 (±3) (Week 24) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess improvement in Insulin resistance from baseline to 3 months by addition of Pioglitazone 15 mg to optimal dose of Glimepiride 1 or 2 mg plus Metformin 500 mg in participants with uncontrolled T2DM
2. To assess improvement in Glycemic parameters from baseline to 3 & 6 months by addition of Pioglitazone 15 mg to optimal dose of Glimepiride 1 or 2 mg plus Metformin 500 mg in participants with uncontrolled T2DM
3. To assess the safety of the FDC of Pioglitazone 15mg, glimepiride 1or 2mg plus metformin 500mg during the study period
|
Visit 1: Screening Visit (Within 14 days)
Visit 2: Baseline Visit (Day 1)
Visit 3: Day 43 (±3) (Week 6)
Visit 4: Day 85 (±3) (Week 12)
Visit 5: Day 127 (±3) (Week 18)
Visit 6: Day 169 (±3) (Week 24) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="1"
Months="0"
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
|
This is a prospective, open-label, single-arm clinical study aimed at
evaluating the effectiveness and safety of Pioglitazone 15 mg as an add-on
therapy in Indian participants with Type 2 Diabetes Mellitus (T2DM) who are
inadequately controlled on optimal doses of Glimepiride (1 or 2 mg) plus
Metformin (500 mg). A total of 60 participants will be enrolled in the study.
The primary objective is to assess the improvement in insulin resistance
by measuring the change in Homeostatic Model Assessment for Insulin Resistance
(HOMA-IR) from baseline to 3 and 6 months following the addition of
Pioglitazone.
The secondary objectives
include evaluating the improvement in glycemic parameters—namely Glycated
Hemoglobin (HbA1c), Fasting Plasma Glucose (FPG), Postprandial Plasma Glucose
(PPG), and fasting insulin—at 3 and 6 months. The safety profile of the
fixed-dose combination (FDC) of Pioglitazone 15 mg, Glimepiride 1 or 2 mg, and
Metformin 500 mg will also be assessed through the mean change in the number
and percentage of participants experiencing adverse events (AEs) or serious
adverse events (SAEs) during the study period. Overall, the study aims to
provide evidence on the efficacy and safety of triple oral therapy in improving
insulin resistance and glycemic control in T2DM patients who are sub optimally
managed on dual therapy. |