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临床试验/CTRI/2021/11/037753
CTRI/2021/11/037753招募中4 期

A 24 week randomized controlled trial assessing the effect of Glimepiride/ Metformin/ Vildagliptin/ Dapagliflozin on glycemic control in novel subtypes - Trial phase IV.

USV Private Limited1 个研究点 分布在 1 个国家目标入组 576 人开始时间: 2021年3月11日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
576
试验地点
1
主要终点
Change in HbA1c between assigned treatment and control groups

研究概览

简要总结

Type 2 diabetes (T2D) exhibits considerable heterogeneity in its pathophysiology and clinical presentation. Identifying distinct T2D subgroups, characterized by clustering of phenotypic traits, has the potential to identify subsets of patients at differential risk of complications, and who are likely to respond differentially to various anti-diabetic medications. In a recent study of the Scandinavian population,five distinct ‘clusters’ of individuals with diabetes with significantly diverse characteristics were identified,  Anjana et al, (2020) identified four replicable clusters among the Asian population. The four identifies clusters are Severe Insulin Deficient Diabetes (SIDD), Insulin Resistant Obese Diabetes (IROD), Combined Insulin Resistance and Deficient Diabetes (CIRDD), and Mild Age-Related Diabetes (MARD). Classifying T2D patients into phenotypic clusters provides insights into the pathophysiological processes driving diabetes, and aid in appropriate treatment selection, risk prediction, and focusing attention on individuals with the highest risk of morbidity and mortality . Though metformin is the first line of drug for T2D, not all patients respond equally well to it, necessitating the addition of other classes of antidiabetic agents to achieve glycemic targets. The selection of appropriate medication as initial therapy has the potential to minimize this delay and hasten the achievement of treatment goals. We, therefore, aim to assess the glycemic response of individuals with new-onset diabetes to different classes of anti-diabetic medications.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • New onset of Type 2 diabetes (within 2 years of diagnosis)
  • Drug naive
  • Body Mass Index (BMI) ≤ 40.0 kg/m2
  • HbA1c (Glycated Hemoglobin) ≥ 7.0%.

排除标准

  • Type 1 Diabetes
  • Use of any oral hypoglycemic agents or Insulin in past
  • Patients with a serum creatinine concentration greater than 132.6 mmol/L or liver function impairment
  • Significant alcohol, drug, or medication abuse
  • Currently under psychiatric care or using antipsychotic or mood stabilizer medication or diagnosed to have dementia or bipolar disorder or schizophrenia
  • History of anemia or hemoglobinopathy and/ or hemoglobin < 10 g/dL for men , <9 g/dL for women
  • Pregnant or lactating women
  • Documented CVD event in past 12 months.

结局指标

主要结局

Change in HbA1c between assigned treatment and control groups

时间窗: From baseline to week 12 and 24

次要结局

  • Change in CGM profile(From baseline to week 24)
  • Change in BMI(From baseline to 12 and 24 weeks)
  • Change in FPG and 2-hour PPG levels(From baseline to 12 and 24 weeks)
  • Change in HOMA - B(From baseline to week 24)
  • Change in HOMA - IR(From baseline to week 24)
  • Change in Lipid profile(From baseline to week 24)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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