CTRI/2024/10/074542尚未招募4 期
A comparative evaluation of safety and efficacy of Vildagliptin with Metformin versus Vildagliptin with Metformin along with Zinc as an adjuvant in newly diagnosed Type 2 Diabetes Mellitus patients in a tertiary care Hospital, Kanpur (U.P)
ANJALY MARY VARGHESE1 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2024年10月3日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Target FBS, PPBS and HbA1c
研究概览
简要总结
This study is a randomized, open labeled, parallel group, single- centre trial comparing the efficacy and safety of metformin 1000 mg / Vildagliptin 100 mg daily and metformin 1000 mg / Vildagliptin 100 mg/ Zinc 25 mg daily for 36 weeks in 410 patients with newly diagnosed type 2 diabetes that will be conducted in a tertiary care hospital, Kanpur, India. The primary outcome measures will be achieving target blood sugar and glycosylated hemoglobin A1C (<7) during 12, 24, 36 weeks of study period. The secondary outcomes will be evaluation of safety of the treatment at 12, 24, 36 weeks and patient compliance.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are newly diagnosed as suffering from Type 2 Diabetes mellitus not on any oral hypoglycemic agent.
- •Patients with HbA1c between (7.0-9.5%), fasting glucose levels of above 126mg per dl or random blood glucose above or equal to 200mg/dl.
- •Patients willing to participate in the trial, ready to abide by trial procedures and willing to give written informed consent.
排除标准
- •Patients with active liver (more than 3 fold rise in ALT/AST) or kidney diseases, malignancies, neurological diseases, endocrine disorders, autoimmune diseases, and cardiovascular diseases.
- •Uncontrolled hypertension (with systolic blood pressure: ≥180 mm Hg/diastolic blood pressure: ≥100 mm Hg).
- •Smokers/ Alcoholics.
- •Pregnant / lactating women.
- •Acute pancreatitis, cystic fibrosis, hemochromatosis.
- •Patient having known hypersensitivity to the study drugs.
结局指标
主要结局
Target FBS, PPBS and HbA1c
时间窗: 12, 24, 36 weeks
次要结局
- Adverse drug events(Patient compliance)
研究者
ANJALY MARY VARGHESE
Rama Medical College Hospital and Research Centre
研究点 (1)
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