Prospective Observational Study to Assess Correlation Between Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes Treated With Sulfonylurea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,069
- 主要终点
- Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores
研究概览
简要总结
This study will assess the correlation between glycemic control and the hypoglycemia symptom score in patients with Type 2 diabetes, 12 weeks after addition of a sulfonylurea to an ongoing regime of oral hypoglycemic agents.
详细描述
Patients will be evaluated for participation in the study during their usual visit to participating diabetes care clinics. Addition of sulfonylurea will be an unbiased decision of the participating physicians based on the clinical needs of the participating patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 2 Diabetes, of either gender and aged between 18-75 years
- •Patients being considered for addition of Sulfonylurea on background of at least one other oral hypoglycemic agent, on a usual visit (screening cum enrolment visit), as per the clinical situation judged by participating physician
- •Willing to comply with study requirements
排除标准
- •Patients with type 1 Diabetes or gestational Diabetes
- •Patients currently on insulin therapy or have received Insulin in last 6 months
- •Patients currently on Sulfonylurea therapy or have received Sulfonylureas in last 6 months
- •Patients currently on Meglitinides therapy or have received Meglitinides in last 6 months
- •Patients initiated on Sulfonylurea monotherapy
- •Patient on DPP-4 inhibitors, either as monotherapy or as combination therapy
- •Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
- •Patients for whom it would be impossible to complete the questionnaire for whatever reason, in any feasible form
- •Patients who are already participating in a clinical trial or other clinical study
研究组 & 干预措施
All participants
Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral hypoglycemic agent(s).
干预措施: Sulfonylurea (Drug)
结局指标
主要结局
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores
时间窗: Week 12
Coefficient of correlation was measured using a linear regression analysis for the association between two variables, HbA1c values at Week 12 and hypoglycemia scores. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.
次要结局
- Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)(Week 12)
- Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)(Week 12)
- Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12(Baseline and Week 12)