Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea

Phase 3

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: sotagliflozin (SAR439954); Drug: placebo; Drug: metformin; Drug: sulfonylurea

• Registration Number: NCT03761134
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c (HbA1c) reduction in Chinese patients with type 2 diabetes (T2D) who have inadequate glycemic control on metformin alone or metformin in combination with sulfonylurea.

Secondary Objectives:

To compare sotagliflozin dose 1 versus placebo for change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT), change in fasting plasma glucose (FPG), and change in body weight.

* To compare sotagliflozin dose 2 versus placebo for change in HbA1c, change in 2-hour PPG following a MMTT, change in FPG, and change in body weight.

* To compare sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo for change in systolic blood pressure (SBP) for all patients, and change in SBP for patients with baseline SBP ≥130 mmHg.

* To evaluate the safety of sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo.

Detailed Description

Total study duration is up to 30 weeks, including a screening period consisting of a screening phase of up to 2 weeks and a 2-week single-blind placebo run-in phase, a 24-week double-blind treatment period, and a 2-week post-treatment follow-up visit period to collect safety information.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-11-29
• Study Start: 2018-11-30
• Study First Posted: 2018-12-03
• Primary Completion: 2020-04-29
• Study Completion: 2020-04-29
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 377

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sotagliflozin dose 1	sotagliflozin (SAR439954)	Sotagliflozin dose 1, given as two (2) dose 2 tablets, once daily, before the first meal of the day
Sotagliflozin dose 2	metformin	Sotagliflozin dose 2, given as 1 sotagliflozin dose 2 tablet and 1 sotagliflozin-matching placebo tablet (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day
Placebo	sulfonylurea	Two sotagliflozin-matching placebo tablets (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day
Sotagliflozin dose 1	metformin	Sotagliflozin dose 1, given as two (2) dose 2 tablets, once daily, before the first meal of the day
Sotagliflozin dose 2	sotagliflozin (SAR439954)	Sotagliflozin dose 2, given as 1 sotagliflozin dose 2 tablet and 1 sotagliflozin-matching placebo tablet (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day
Sotagliflozin dose 1	sulfonylurea	Sotagliflozin dose 1, given as two (2) dose 2 tablets, once daily, before the first meal of the day
Sotagliflozin dose 2	placebo	Sotagliflozin dose 2, given as 1 sotagliflozin dose 2 tablet and 1 sotagliflozin-matching placebo tablet (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day
Sotagliflozin dose 2	sulfonylurea	Sotagliflozin dose 2, given as 1 sotagliflozin dose 2 tablet and 1 sotagliflozin-matching placebo tablet (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day
Placebo	placebo	Two sotagliflozin-matching placebo tablets (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day
Placebo	metformin	Two sotagliflozin-matching placebo tablets (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin A1c (HbA1c)	Baseline to Week 24	Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose 1)

Secondary Outcome Measures

Name	Time	Method
Change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT)	Baseline to Week 24	Absolute change from baseline to week 24 in 2-hour PPG following a MMTT (for sotagliflozin dose1 and 2)
Change in HbA1c	Baseline to Week 24	Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose 2)
Change in body weight	Baseline to Week 24	Absolute change from baseline to week 24 in body weight (for sotagliflozin dose1 and 2)
Adverse events	Up to Week 24	Number of patients with adverse events
Change in fasting plasma glucose (FPG)	Baseline to Week 24	Absolute change from baseline to week 24 in FPG (for sotagliflozin dose 1 and 2)
Change in SBP for patients with baseline SBP ≥130 mmHg	Baseline to Week 12	Absolute change from baseline to week 12 in SBP for patients with baseline SBP ≥130 mmHg (for sotagliflozin dose 1 and 2)
Change in systolic blood pressure (SBP) for all patients	Baseline to Week 12	Absolute change from baseline to week 12 in SBP for all patients (for sotagliflozin dose 1 and 2)

Trial Locations

Locations (40)

Investigational Site Number 1560039; 🇨🇳 Baotou, China

Investigational Site Number 1560028; 🇨🇳 Dalian, China

Investigational Site Number 1560040; 🇨🇳 Baotou, China

Investigational Site Number 1560001; 🇨🇳 Beijing, China

Investigational Site Number 1560035; 🇨🇳 Cangzhou, China

Investigational Site Number 1560011; 🇨🇳 Changsha, China

Investigational Site Number 1560021; 🇨🇳 Changzhou, China

Investigational Site Number 1560032; 🇨🇳 Guangzhou, China

Investigational Site Number 1560027; 🇨🇳 Guangzhou, China

Investigational Site Number 1560038; 🇨🇳 Beijing, China

Investigational Site Number 1560020; 🇨🇳 Changchun, China

Investigational Site Number 1560012; 🇨🇳 Changchun, China

Investigational Site Number 1560024; 🇨🇳 Chongqing, China

Investigational Site Number 1560010; 🇨🇳 Dalian, China

Investigational Site Number 1560036; 🇨🇳 Dalian, China

Investigational Site Number 1560030; 🇨🇳 Fuzhou, China

Investigational Site Number 1560006; 🇨🇳 Jinan, China

Investigational Site Number 1560018; 🇨🇳 Pingxiang, China

Investigational Site Number 1560034; 🇨🇳 Luoyang, China

Investigational Site Number 1560046; 🇨🇳 Harbin, China

Investigational Site Number 1560041; 🇨🇳 Hangzhou, China

Investigational Site Number 1560009; 🇨🇳 Hefei, China

Investigational Site Number 1560025; 🇨🇳 Hohhot, China

Investigational Site Number 1560026; 🇨🇳 Huai'An, China

Investigational Site Number 1560033; 🇨🇳 Kunming, China

Investigational Site Number 1560003; 🇨🇳 Shanghai, China

Investigational Site Number 1560004; 🇨🇳 Shanghai, China

Investigational Site Number 1560013; 🇨🇳 Shanghai, China

Investigational Site Number 1560005; 🇨🇳 Shenyang, China

Investigational Site Number 1560019; 🇨🇳 Shijiazhuang, China

Investigational Site Number 1560017; 🇨🇳 Suzhou, China

Investigational Site Number 1560022; 🇨🇳 Wuhan, China

Investigational Site Number 1560023; 🇨🇳 Wuxi, China

Investigational Site Number 1560015; 🇨🇳 Xiangtan, China

Investigational Site Number 1560007; 🇨🇳 Zhenjiang, China

Investigational Site Number 1560037; 🇨🇳 Zhongshan, China

Investigational Site Number 1560043; 🇨🇳 Yuncheng, China

Investigational Site Number 1560016; 🇨🇳 Zhuzhou, China

Investigational Site Number 1560042; 🇨🇳 Zhengzhou, China

Investigational Site Number 1560014; 🇨🇳 Nanjing, China