A pilot study to investigate remission of Type 2 Diabetes using combination of Tirzepatide and Dapagliflozin as an adjunct to Metformin
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To determine the remission rates in individuals with Diabetes mellitus Type 2 receiving a combination of oral Tirzepatide and Dapagliflozin in addition to Metformin monotherapy, and to compare these rates with standard diabetes management practices.
研究概览
简要总结
Type 2 diabetes mellitus (T2DM) represents a significant and escalating global health challenge, characterized by chronic hyperglycaemia resulting from insulin resistance, impaired insulin secretion, or both. The long-term complications associated with T2DM, including cardiovascular disease, nephropathy, retinopathy, and neuropathy, impose a substantial burden on individuals and healthcare systems worldwide. While current management strategies primarily focus on achieving and maintaining glycaemic control to prevent these complications, the concept of achieving disease remission has gained increasing attention as a more ambitious and potentially impactful therapeutic goal. Remission, defined as the sustained achievement of non-diabetic glycaemic levels without the need for glucose-lowering medications, holds the promise of reducing the risk of long-term complications, improving patients’ quality of life, and potentially decreasing healthcare expenditures.
This pilot study aims to investigate the efficacy and safety of a novel triple combination therapy involving Tirzepatide, Dapagliflozin, and Metformin for inducing remission in patients with type 2 diabetes. Tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, represents a new class of incretin-based therapies demonstrating remarkable efficacy in glycaemic control and weight loss 1. Dapagliflozin, a selective sodium-glucose cotransporter-2 (SGLT2) inhibitor, lowers blood glucose by increasing urinary glucose excretion and has shown significant cardiovascular and renal benefits 2. Metformin, a biguanide, remains the cornerstone of initial pharmacological treatment for T2DM due to its effectiveness in reducing hepatic glucose production and improving insulin sensitivity, coupled with a favourable safety profile and long-term cardiovascular benefits 4. By combining these three agents, each with distinct yet complementary mechanisms of action, this study seeks to explore the potential for a synergistic effect that could lead to a higher rate of diabetes remission compared to existing treatment paradigms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diabetes Mellitus type 2 diagnosed within 2 years.
排除标准
- •BMI less than 23kg per m2 Current Insulin or GLP1 analogue or SGLT2 inhibitor therapy.
- •Acute or Chronic Pancreatitis History of Ketoacidosis Objective evidence of Diabetic Neuropathy.
- •Renal Failure defined as eGFR less than 60 ml per min per 1.73m
- •24hr Urinary protein more than 500 mg or Albumin to Creatinine ratio more than 300mg per g.
- •Moderate to Severe NPDR or PDR or diabetic maculopathy.
- •Liver disease defined as ALT more than 3 times ULN, Bilirubin more than 2 mg per dl, USG evidence of Cirrhosis.
- •Any major chronic illness.
- •Symptomatic Coronary artery disease or Peripheral arterial disease or cardiac Failure or Acute coronary syndrome less than 3 months duration Diabetic Foot On steroid treatment.
- •Positive GAD Fasting C -peptide less than 1.2 ng per ml Post COVID-Diabetes (onset of diabetes within 3 months of COVID).
结局指标
主要结局
To determine the remission rates in individuals with Diabetes mellitus Type 2 receiving a combination of oral Tirzepatide and Dapagliflozin in addition to Metformin monotherapy, and to compare these rates with standard diabetes management practices.
时间窗: At Baseline, after 9 months
次要结局
- To measure changes in beta- cell function following treatment, as assessed by mixed meal tolerance test.(At Baseline, after 9 months)
研究者
Sunil Mishra
Post Graduate Institute of Medical Education and Research