Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: 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
Sponsors
Abbott Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)Timepoint: 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
| Measure | Time frame |
|---|---|
| 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 Timepoint: 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) | — |
Countries
India
Contacts
Public ContactDr Mangesh Shende
Shilpa Medical Research Centre
Outcome results
None listed