Symlin® Dose Escalation Efficacy vs. Conventional Therapy in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Glucose control
研究概览
简要总结
The hypothesis of the study is that those obese patients with type 2 diabetes mellitus who do not respond to the FDA approved dose of 120 mcg of pramlintide (Symlin®) 3 times daily with expected glucose control require higher than FDA approved dosage.
The primary objective of the study is to determine whether higher doses of pramlintide (Symlin®) in patients with type 2 diabetes mellitus control glucose better than the FDA approved dose of 120 mcg three times daily.
The secondary objectives include proving whether higher dose pramlintide (Symlin®) is more efficacious in causing weight loss and reduction in waist circumference than standard dose pramlintide (Symlin®),to determine whether blood levels of certain hormones correlate with need for higher dose therapy,and to determine whether or not the rate of common adverse effects exceeds the maximum FDA approved pramlintide (Symlin®) dose of 120 mcg three times daily.
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
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
- •Age 18-80 years.
- •Type 2 diabetes mellitus.
- •Obese (BMI > 30 kg/m2), waist circ. >35" women, >40" men.
- •Basal insulin plus at least 2 injections of mealtime insulin daily or pre-mixed insulin.
- •On stable insulin dose for at least 3 mos (baseline + 20%, no minimum).
- •If pramlintide treated, on stable full dose for at least 3 months.
- •A1c > 7.0% and < 9.0%.
- •Women of childbearing age if using a reliable form of birth control.
- •Women of childbearing age if post tubal ligation or surgical menopause.
- •Able to consent.
- •Willing to perform self-monitoring of glucose.
- •Willing to attend study visits.
- •Written informed consent to participate in the study.
- •Agreement to maintain prior diet and exercise throughout the full course of the study.
排除标准
- •Age <18 or >80 years.
- •Confirmed gastroparesis or taking medications affecting gastric motility.
- •A1c <7.0% or >9.0%.
- •Recurrent severe hypoglycemia or hypoglycemic unawareness.
- •Creatinine clearance <30 ml/min.
- •History of MI <6 mos prior to enrollment.
- •History of ventricular arrhythmia.
- •History of cancer or chemotherapy <6 mos prior to enrollment.
- •Laboratory abnormalities as follows:
- •Liver enzymes >3X ULN.
- •Hematocrit less than
- •Serum creatinine >2.5 mg/dl.
- •Fasting triglycerides >500 mg/dl.
- •Pregnancy or nursing.
- •Inability to provide consent.
- •Unwilling to attend study visits.
- •Unwilling to perform self-monitoring of glucose.
- •Chronic oral or parenteral glucocorticoid therapy (over one week of treatment) within 3 months prior to screening.
- •Investigational drug treatment within 3 months prior to screening.
- •Donation of blood, significant blood loss or transfusion within 3 months of screening.
- •History of acromegaly or Cushing's syndrome.
- •Use of prohibited concomitant medications.
- •Type 1 diabetes mellitus.
- •Acute metabolic complication (hyperosmolar state) <6 months prior to screening.
研究组 & 干预措施
Symlin Naive, Usual Dose
Symlin 120 mcg three times daily in patients not previously treated with pramlintide before the study.
干预措施: Pramlintide (Drug)
Symlin Naive, Dose Escalation
Escalation of pramlintide dose to 360 mcg three times daily in patients not taking pramlintide prior to study.
干预措施: Pramlintide (Drug)
Symlin treated, Usual Dose
pramlintide 120 mcg three times daily in patients who have been treated with pramlintide 120 mcg prior to the trial.
干预措施: Pramlintide (Drug)
Symlin Treated, Dose Escalation
pramlintide 360 mcg three times daily in patients previously treated with 120 mcg prior to the study.
干预措施: Pramlintide (Drug)
结局指标
主要结局
Glucose control
时间窗: 6 months
A1c Fasting plasma glucose Post-prandial glucose Glycomark
次要结局
- Weight loss(6 months)
- amylin level(initial)
- glucagon level(6 months)
- adverse effects(6 months)
研究者
Cheryl Rosenfeld, DO
Principal Investigator
North Jersey Endocrine Consultants, LLC