Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity on Endogenous Glucose Production in Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Contribution of gluconeogenesis (GNG) to endogenous glucose production (EGP)
研究概览
简要总结
It has been shown that individuals with type 2 diabetes have higher blood sugar throughout the night than individuals without type 2 diabetes. However, it is still unknown if this rise in blood sugar can be controlled using medications.
This study will examine the effects of three different diabetes treatments to determine if they improve night time blood sugars. Participants will be randomly assigned for 8 weeks to one of the following three groups:
GROUP 1: Insulin. Participants will be instructed on self-injecting insulin glargine once-daily in the morning. The dose will be increased by the study team to avoid episodes of low blood sugar and to maintain fasting blood sugar concentrations between 70 to 180 mg/dl.
GROUP 2: Metformin. Participants will start the drug (500 mg twice daily) with meals. After 72 hours and in the absence of side effects, they will increase the dose to 500 mg with breakfast and 1,000 mg with supper. After a further 72 hours and in the absence of side effects, they will increase the dose to 1,000 mg twice daily with meals and continue until the end of the trial. The dose will be adjusted by the study team to maintain fasting blood sugar concentrations between 70 to 180 mg/dl.
GROUP 3: Dorzagliatin. This medication dose will be 75 mg twice daily. The investigators anticipate fasting glucose concentrations will be between 70 to 180 mg/dl since the dose of this medication cannot be titrated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI:25-40 kg/m
- •HbA1C ≤ 9% on lifestyle therapy with or without monotherapy with metformin or sulphonylureas (SU); or combination therapies (metformin and SU, DPPIV inhibitors, only short acting GLP-1 analogues exenatide (Byeta) and liraglutide (Victoza).
排除标准
- •Insulin therapy
- •SGLT2 inhibitors
- •Long acting GLP-1 analogues
- •Medications affecting GI motility (e.g., erythromycin, pramlintide).
- •Medications that may affect glucose metabolism such as corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, and anticoagulants.
- •Unstable diabetic retinopathy, microalbuminuria, macrovascular disease.
- •Upper GI disorder/surgery, debilitating chronic disease, anemia, and symptoms of undiagnosed illnesses.
- •History of alcoholism or substance abuse.
- •Pregnancy or breast feeding, or other comorbidities precluding participation.
研究组 & 干预措施
Metformin
干预措施: Metformin (Drug)
Insulin Glargine
干预措施: Insulin Glargine (Drug)
Dorzagliatin
干预措施: Dorzagliatin (Drug)
结局指标
主要结局
Contribution of gluconeogenesis (GNG) to endogenous glucose production (EGP)
时间窗: 8 weeks
Ratio of GNG to total EGP
次要结局
- Contribution of glycogenolysis (GLY) to EGP(8 weeks)
- Glucokinase activity(8 weeks)
研究者
Rita Basu
Professor of Medicine
University of Alabama at Birmingham