Effect of Vildagliptin & Metformin Combination on Glycemic Control and Hypoglycemic Episodes. An Observational Real Life Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change from baseline in Random blood sugar (RBS) and fasting blood sugar (FBS) levels at week 12 in participants receiving Vildagliptin combination with Metformin
研究概览
简要总结
To evaluate the changes from baseline in random blood sugar (RBS) and fasting blood sugar (FBS) levels at week 12 in participants receiving Vildagliptin combination with Metformin.
详细描述
Galvecta Plus is a combination of Vildagliptin and Metformin hydrochloride. Combination drug with complementary mechanisms of action, provides efficacy and allows to reach glycemic targets compared to continuing metformin monotherapy and is used as an oral hypoglycemic in Type II diabetes mellitus that shows potential to achieve better blood glucose without increasing the risk of hypoglycemia, exposing to weight gain and altering common cardiovascular risk factors (hypertension and lipid profile). The fact that Vildagliptin with metformin substantially enhances the incretin effect. Vildagliptin belongs to dipeptidyl peptidase-4 (DPP-4) inhibitor. Inhibition of dipeptidyl peptidase-4 (DPP-4) by Vildagliptin prevents degradation of glucagon-like peptide-1 (GLP-1) and reduces glycaemia in patients with type 2 diabetes mellitus, with low risk for hypoglycemia and no weight gain and metformin is a Biguanides with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycemia.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with type 2 diabetes mellitus (DM).
- •Patient with HbA1c levels greater than 7.0% who were naïve or were receiving monotherapy with oral hypoglycemic agent were eligible to participate in the study.
排除标准
- •Patient with a history diabetic ketoacidosis, clinically significant liver or renal disease, congestive heart failure requiring pharmacological treatment, coronary artery percutaneous intervention or unstable angina within the past 6 month excluded from study
- •Participants who are pregnant or with gestational DM
- •Age over 80 years
- •Hypersensitivity to any active ingredient.
结局指标
主要结局
Change from baseline in Random blood sugar (RBS) and fasting blood sugar (FBS) levels at week 12 in participants receiving Vildagliptin combination with Metformin
时间窗: Week 12
To determine the efficacy of vildagliptin/metformin changes from baseline in random blood sugar (RBS) and fasting blood sugar (FBS) levels after 12 weeks of therapy. \[Designated as safety issue: No \]
次要结局
- Changes from baseline in HbA1c Levels at Week 12 in participants receiving Vildagliptin combination with Metformin(Week 12)
- Number of participants who experienced an Adverse Event(12 weeks)
- Number of participants experiencing hypoglycemic episodes in the 12 weeks receiving Vildagliptin combination with Metformin.(Week 12)