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临床试验/NCT02846233
NCT02846233已完成不适用

Is the Stepping-down Approach a Better Option Than Multiple Daily Injections in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Change in A1c at the End of Study Period

研究概览

简要总结

In traditional step-up approach, the patients with poorly-controlled type 2 diabetes are instructed to take up to 4 insulin injections daily or multiple daily injections (MDI) as the most advanced therapy. However, a significant number of these patients continue to have poor diabetes control. The most common reason is the noncompliance with multiple injections and the patient's reluctance to accept insulin-induced weight gain. More recently, the algorithm in diabetes management has significantly changed to accommodate the newer generation of medications. Addition of the diabetes medications, that can induce weight loss such as oral Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors and once-weekly glucagon-like peptide (GLP)-1 receptor agonists (GLP1 RA) injection, to a basal insulin is now recommended before the patient is advanced to MDI. This approach works very well in most patients since weight loss gives the patients an extra motivation to take medication regularly. Similarly, the patient does not require to take an insulin injection before each meal throughout the day in this approach.

Unfortunately, there are still a large number of patients with poor glycemic control who are still on MDI. Some of them were initiated on MDI before the availability of newer generations of medications. Some were started simply because the physician was not aware of or not the familiar with the new recommendations. Regardless of the reason, these patients are likely to remain on MDI despite chronic poor glycemic control since the physicians are understandably reluctant to step down the most advanced insulin therapy. In addition, there has been no data on the benefits and safety of the stepping-down approach from the most advanced insulin therapy to the more patient-friendly approach that is the combined use of oral SGLT2i and once-weekly GLP1 RA injection.

详细描述

A prospective, randomized, open-label, controlled, parallel-group trial is planned. This study is an interdepartmental collaborative study among the Department of Internal Medicine, Department of Family & Community Medicine (UCSF Fresno), Sierra Vista Family Medicine Residency Program and Division of Endocrinology.

The study will be conducted at the following multiple locations in order to maximize the patient recruitment:

  1. Internal medicine clinic at Derian Koligian ambulatory care center (ACC)
  2. Family practice medicine clinic at ACC
  3. Diabetes clinic at ACC
  4. Internal medicine clinic at University Medicine Associates in East medical Plaza
  5. Endocrine clinic at University Medicine Associates in East medical Plaza
  6. Sierra Vista clinics

The patients will be recruited during the first 12 months of the study or until the predetermined sample size is reached, whichever comes first.

The patient's primary care provider will be informed of the enrollment in the study if the participant gives the permission to do so.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The following patients with diabetes mellitus type 2 who can give written consent will be eligible for enrollment. They must meet all criteria.
  • > 21 years of age
  • Body mass index (BMI) ≥30 kg/m2
  • On insulin at least 2 times daily comprising both a basal and a prandial insulin or a pre-mix insulin with or without other non-insulin medications for a least past 3 months

排除标准

  • The patients with any of the following criteria will be excluded.
  • Any patient who does not meet the above inclusion criteria.
  • Patients who are on a SGLT2i and a GLP1 RA injection at the time of enrollment.
  • diabetes mellitus type 1
  • C-peptide below normal range if measured in the past.
  • patients with a history of diabetes ketoacidosis
  • A history of recent and frequent (≥ 2 times within past 3 months) urinary tract infection or genito-urinary candidiasis requiring antibiotic and/or anti-fungal therapies.
  • a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • patients with a history of acute pancreatitis

研究组 & 干预措施

Treatment group

Active Comparator

Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.

干预措施: GLP1 receptor agonist (Drug)

Treatment group

Active Comparator

Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.

干预措施: basal insulin (Drug)

Treatment group

Active Comparator

Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.

干预措施: SGLT2 inhibitor (Drug)

Treatment group

Active Comparator

Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.

干预措施: Metformin (Drug)

结局指标

主要结局

Change in A1c at the End of Study Period

时间窗: 16 weeks (from baseline to end of study at 16 weeks)

change in A1c (%) from baseline to end of study at 16 weeks

次要结局

  • Changes in Blood Pressure(16 weeks (from baseline to end of study at 16 weeks))
  • Changes in Weight(16 weeks (from baseline to end of study at 16 weeks))
  • Changes in Total Cholesterol(16 weeks (from baseline to end of study at 16 weeks))
  • Changes in Serum Creatinine(16 weeks (from baseline to end of study at 16 weeks))
  • Changes in LDL(16 weeks (from baseline to end of study at 16 weeks))
  • Changes in Heart Rate(16 weeks)
  • Changes in Treatment Satisfaction Scores (DM-SAT Total Score)(16 weeks (from baseline to end of study at 16 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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