Association of Fasting GLP-1 Level With the Effect of Linagliptin After an Oral Glucose Tolerance Test in Prediabetes and Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change from baseline in HbA1c after 12-week treatment
研究概览
简要总结
There are studies that suggest glycemic response to incretin-based therapies differs between Asians and Caucasians, whereby Asians have better response compared to Caucasians. Hence, the therapeutic response could also be augmented by difference in incretin system among various ethnicities. This study is carried out to study the effect of dipeptidyl-peptidase IV (DPPIV) inhibitors in prediabetes and T2DM patients who have different levels of GLP-1 and to determine the effect on glycemic profiles, insulin resistance/sensitivity, beta-cell functon.
详细描述
A 12-week, open-label, single treatment study using linagliptin is conducted in 28 prediabetes and 22 T2DM subjects who are divided into low and high fasting GLP-1 groups. Prediabetes are recruited from OGTT screening. Type 2 diabetes patients are recruited from specialised diabetes clinic and routine follow-up. A 75-g oral glucose tolerance test (OGTT) is performed at week 0 and 12. Venous blood samples were drawn at times 0 (before initiation of OGTT), 30, 60, 90, 120 min from the indwelling catheter for measurement of glucose and insulin.All prediabetes and T2DM subjects receive Linagliptin 5mg once daily for a duration of 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prediabetes diagnosed from OGTT and T2DM subjects
- •HbA1c > 6.5% and <10%
- •Subjects not receiving any glucose-lowering medication or just receiving metformin and/or sulphonylureas and/or alpha-glucosidase inhibitors on stable dose for at least 3 months.
- •Subjects who are willing to participate and sign the informed consent form
排除标准
- •Subjects with ketoacidosis or lactic acidosis, overt diabetes, another disease causing secondary glucose intolerance, congestive heart failure (New York Heart Association Class III or IV), myocardial infarction, stroke or ischemic attacks in past 6 months, uncontrolled severe hypertension, active liver conditions such as cirrhosis or hepatitis [elevation in liver enzymes to higher activities than double the respective normal value], moderate to severe renal insufficiency, pregnancy, breast-feeding
- •Patients receiving insulin, GLP-1 receptor agonists, dipeptidyl peptidase IV inhibitors or glucose-lowering medications other than metformin /sulphonylureas /alpha-glucosidase inhibitors as treatment.
- •Subjects with uncontrolled blood glucose HbA1c>10%
- •Subjects who plan to move out of state / country
研究组 & 干预措施
Prediabetes Low GLP-1
prediabetes patients were divided into high GLP-1 and low GLP-1 groups based on the median of fasting GLP-1 level. linagliptin 5mg once daily was administered.
干预措施: Dipeptidyl-Peptidase IV Inhibitors (Drug)
Prediabetes High GLP-1
prediabetes patients were divided into high GLP-1 and low GLP-1 groups based on the median of fasting GLP-1 level. linagliptin 5mg once daily was administered.
干预措施: Dipeptidyl-Peptidase IV Inhibitors (Drug)
Diabetes Low GLP-1
type 2 diabetes mellitus patients were divided into high GLP-1 and low GLP-1 groups based on the median of fasting GLP-1 level. linagliptin 5mg once daily was administered.
干预措施: Dipeptidyl-Peptidase IV Inhibitors (Drug)
Diabetes High GLP-1
type 2 diabetes mellitus patients were divided into high GLP-1 and low GLP-1 groups based on the median of fasting GLP-1 level. linagliptin 5mg once daily was administered.
干预措施: Dipeptidyl-Peptidase IV Inhibitors (Drug)
结局指标
主要结局
change from baseline in HbA1c after 12-week treatment
时间窗: baseline to 12 weeks
plasma level of fasting HbA1c is taken at week 0 and 12 of study before OGTT
change from baseline in glucose after 12-week treatment
时间窗: baseline to 12 weeks
OGTT is performed at week 0 (baseline) and 12 (complete treatment). plasma glucose levels are taken at time 0,30,60,90,120 minutes during OGTT.
change from baseline in insulin sensitivity/resistance index after 12-week treatment
时间窗: baseline to 12 weeks
OGTT is performed at week 0 (baseline) and 12. Plasma levels of glucose and insulin are taken at time 0,30,60,90,120 min during the OGTT. HOMA-IR, HOMA-IS are used to measure insulin resistance and insulin sensitivity at week 0 and week 12
次要结局
- change from baseline in beta-cell function after 12-week treatment(baseline to 12 weeks)
研究者
Chong Shiau Chin
Mrs, principal investigator
National University of Malaysia