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Dose-ranging Study in Patients With Type 1 Diabetes Mellitus (inTandem4)

2020年2月10日 更新者：Lexicon Pharmaceuticals

A Phase 2b, Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study in Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

141

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Concord、California、美国、94520
        • Lexicon Investigational Site
      • Ventura、California、美国、93003
        • Lexicon Investigational Site
    • Colorado
      • Denver、Colorado、美国、80209
        • Lexicon Investigational Site
    • Florida
      • Jacksonville、Florida、美国、32225
        • Lexicon Investigational Site
      • Miami、Florida、美国、33175
        • Lexicon Investigational Site
    • Illinois
      • Springfield、Illinois、美国、62711
        • Lexicon Investigational Site
    • Louisiana
      • Metairie、Louisiana、美国、70006
        • Lexicon Investigational Site
    • Maine
      • Auburn、Maine、美国、04210
        • Lexicon Investigational Site
    • Maryland
      • Rockville、Maryland、美国、20852
        • Lexicon Investigational Site
    • Montana
      • Great Falls、Montana、美国、59405
        • Lexicon Investigational Site
    • Nebraska
      • Omaha、Nebraska、美国、68114
        • Lexicon Investigational Site
    • North Carolina
      • High Point、North Carolina、美国、27265
        • Lexicon Investigational Site
    • Ohio
      • Columbus、Ohio、美国、43213
        • Lexicon Investigational Site
    • Texas
      • San Antonio、Texas、美国、78229
        • Lexicon Investigational Site
    • Utah
      • Salt Lake City、Utah、美国、84107
        • Lexicon Investigational Site
    • Virginia
      • Chesapeake、Virginia、美国、23321
        • Lexicon Investigational Site
      • Manassas、Virginia、美国、20110
        • Lexicon Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Participant had given written informed consent to participate in the study in accordance with local regulations.
  • Adult participants 18 years and older with a diagnosis of type 1 diabetes mellitus (T1D) made at least 1 year prior to informed consent.
  • Participants were being treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injection (MDI).
  • At the Screening Visit, A1C had to be between 7.0% and 10.0%.
  • Females of childbearing potential had to use an adequate method of contraception and have a negative pregnancy test.

Exclusion Criteria:

  • Use of antidiabetic agent other than insulin or insulin analog at the time of screening.
  • Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening.
  • Chronic systemic corticosteroid use.
  • Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Placebo
Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
药品：安慰剂
安慰剂，每天一次，在一天的第一顿饭前
实验性的：Sotagliflozin 75 mg
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally for 12 weeks.
药品：安慰剂
安慰剂，每天一次，在一天的第一顿饭前
药品：Sotagliflozin
Sotagliflozin,once daily, before the first meal of the day
实验性的：Sotagliflozin 200 mg
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally for 12 weeks.
药品：安慰剂
安慰剂，每天一次，在一天的第一顿饭前
药品：Sotagliflozin
Sotagliflozin,once daily, before the first meal of the day
实验性的：Sotagliflozin 400 mg
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally for 12 weeks.
药品：Sotagliflozin
Sotagliflozin,once daily, before the first meal of the day

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline in Hemoglobin A1C (A1C) at Week 12
大体时间：Baseline to Week 12
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-baseline Least Square (LS) mean values were obtained from mixed-effects model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery method (continuous subcutaneous insulin infusion [CSII] or multiple daily injection [MDI]), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.
Baseline to Week 12

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal
大体时间：Baseline, Week 12
A 2-hour PPG sample (plasma) was obtained 2-hours after a standardized Mixed Meal at Baseline (Day 1) and at the visit at Week 12. Post-Baseline LS mean was obtained from analysis of covariance (ANCOVA) model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and baseline postprandial glucose as a covariate.
Baseline, Week 12
Absolute Change From Baseline in Body Weight to Week 12
大体时间：Baseline to Week 12
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate.
Baseline to Week 12
Percent Change From Baseline in Body Weight to Week 12
大体时间：Baseline to Week 12
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate.
Baseline to Week 12
Change From Baseline to Week 12 in 24-Hour Urinary Glucose Excretion
大体时间：Baseline, Week 12
Urine was collected over 24 hours to measure Urinary Glucose Excretion at baseline, and at the end of the 12-week treatment. Post-Baseline LS mean was obtained from ANCOVA model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and Baseline urinary glucose excretion as a covariate.
Baseline, Week 12
Change From Baseline to Week 12 in Fasting Plasma Glucose
大体时间：Baseline to Week 12
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline fasting plasma glucose-by-time interaction as a covariate.
Baseline to Week 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Lexicon Pharmaceuticals

合作者

Sanofi

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年7月1日

初级完成 (实际的)

2016年8月1日

研究完成 (实际的)

2016年8月1日

研究注册日期

首次提交

2015年5月29日

首先提交符合 QC 标准的

2015年6月1日

首次发布 (估计)

2015年6月2日

研究记录更新

最后更新发布 (实际的)

2020年2月12日

上次提交的符合 QC 标准的更新

2020年2月10日

最后验证

2020年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • LX4211.1-206-T1DM
  • LX4211.206 (其他标识符：Lexicon Pharmaceuticals, Inc.)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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