Evaluation of Insulin Glargine and Exenatide: A Randomized Clinical Trial With Continuous Glucose Monitoring and Ambulatory Glucose Profile Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- HbA1c Change
研究概览
简要总结
The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.
详细描述
The primary objective of this study was to characterize the diurnal glucose patterns produced by insulin glargine alone, exenatide (GLP-1 agonist) alone and the combination of insulin glargine and exenatide in subjects taking stable dose of metformin and to evaluate their efficacy in terms of improvement in glucose exposure, variability, stability, incidence of hypoglycemia and weight management.
An ancillary study was approved as part of this study. The purpose of the ancillary study was to use CGM to characterize the glycemic response to a fixed breakfast meal consumed by study participants receiving different medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Subjects were randomized and then told the medications they were randomized to. Since the medications were already on the market, there was no need for masking for any involved individuals.
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
- •Male or female subjects ≥18 and ≤75 years of age
- •Clinical diagnosis of type 2 diabetes
- •Diabetes duration ≥ 1 year
- •HbA1c ≥7.0%
- •Currently treated with metformin (HbA1c ≤9%) or metformin/sulfonylurea (SU) (HbA1c ≤8%)or SU alone (HbA1c ≤8%)
排除标准
- •Previously treated with insulin or incretin-based therapy
- •Treated with a thiazolidinedione within past 6 weeks
- •Taken oral or injected prednisone or cortisone medications in the previous 30 days
- •Any pancreatic disease or at high risk of pancreatitis (history of alcohol abuse, active gallbladder disease)
- •Serum creatinine >1.4mg/dL (women) or >1.5 mg/dL (men)
- •eGFR (Estimated Glomerular Filtration Rate) <30 ml/min (using MDRD/ Modification of Diet in Renal Disease equation)
- •ALT(Alanine Transaminase) > 2x Upper Limit of Normal (ULN)
- •Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise he subject's safety or successful participation in the study
- •Currently pregnant or planning pregnancy during the study period
- •Unable to follow the study protocol
- •Unable to speak, read and write in English
- •Uncontrolled hyperglycemia with HbA1c > 9% on metformin or >8% on SU or metformin/SU combination or ketonuria requiring immediate insulin therapy
- •At the investigator's discretion for other medical or psychological reasons
研究组 & 干预措施
Exenatide
5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
干预措施: Exenatide (Drug)
Insulin Glargine
.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
干预措施: Insulin Glargine (Drug)
Exenatide + Insulin Glargine
Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
- Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
干预措施: Exenatide (Drug)
Exenatide + Insulin Glargine
Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
- Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
HbA1c Change
时间窗: baseline to final visit (32 weeks)
Measure the changes in HbA1C attributable to exenatide, insulin glargine and their combination. Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin.
次要结局
- Change From Baseline in Incidence of Hypoglycemia (Frequency)(baseline to final visit (32 weeks))
- Change From Baseline in Incidence of Hypoglycemia (Degree)(baseline to final visit (32 weeks))
- Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve)(baseline to final visit (32 weeks))
- Change From Baseline in CGM Glucose Variability(baseline to final visit (32 weeks))
- Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC)(baseline - final visit (32 weeks))
- Change From Baseline in Weight Changes(baseline - final visit (32 weeks))