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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 72.00 Year(s)（—）
- 性别
- All
入选标准
- •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
- •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
- •At least 3 months of treatment with optimal doses of Glimepiride plus Metformin
- •Participants with high HOMA IR greater than 2.9 at the time of enrollment
- •Participants willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations
- •Participants willing to provide informed consent to participate in the study.
排除标准
- •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
- •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.
- •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)
- •Any other clinically significant conditions as per the opinion of investigator.
结局指标
主要结局
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)
时间窗: 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)
次要结局
- 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)
研究者
Dr Mangesh Tiwaskar
Shilpa Medical Research Centre