Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: INSULIN GLARGINE

• Registration Number: NCT02545842
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To identify a best fasting plasma glucose (FPG) target for Chinese type 2 diabetes patients using insulin glargine which can provide the highest control rate of glycated hemoglobin (HbA1c) \< 7%.

Secondary Objectives:

The control rate of HbA1c ≤6.5% achievement. The control rate of HbA1c \<7.0% in patients achieving their FPG target. The percentage of HbA1c \<7% without hypoglycemia. The percentage of patients achieving the FPG target without hypoglycemia. The percentage of patients achieving the FPG target and post prandial glucose (PPG) target (2-hour post breakfast \<10 mmol/L).

Detailed Description

The study duration for each patient will be 27 weeks.

Study Timeline

• Study Start: 2015-09-07
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-10
• Primary Completion: 2018-04-20
• Study Completion: 2018-04-20
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 947

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
Group 1	INSULIN GLARGINE	Insulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of \<=5.6 mmol/L
Group 2	INSULIN GLARGINE	Insulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of \<=6.1 mmol/L
Group 3	INSULIN GLARGINE	Insulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of \<=7.0 mmol/L

Primary Outcome Measures

Name	Time	Method
Percentage of patients with HbA1c <7% achievement	24 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of patients achieving HbA1c <=6.5%	24 weeks
Change from baseline in HbA1c	Baseline to 24 weeks
Percentage of patients achieving FPG target with HbA1c <7%	24 weeks
Percentage of patients achieving PPG target (2-hour post-breakfast <10 mmol/L)	24 weeks
Percentage of patients experienced hypoglycemic events	24 weeks
Percentage of patients achieving HbA1c <7% without hypoglycemia	24 weeks
Percentage of patients achieving the FPG target without hypoglycemia	24 weeks
Percentage of patients achieving FPG target	24 weeks
Change in FPG	8 weeks to 24 weeks
Change in insulin doses in each arm	1 week to 24 weeks
Change in body weight in each treatment arm	Baseline to 24 weeks
Change in PPG	Baseline to 24 weeks

Trial Locations

Locations (44)

Investigational Site Number 156020; 🇨🇳 Nanchang, China

Investigational Site Number 156053; 🇨🇳 Anshan, China

Investigational Site Number 156001; 🇨🇳 Beijing, China

Investigational Site Number 156002; 🇨🇳 Beijing, China

Investigational Site Number 156022; 🇨🇳 Changde, China

Investigational Site Number 156013; 🇨🇳 Changchun, China

Investigational Site Number 156014; 🇨🇳 Changchun, China

Investigational Site Number 156017; 🇨🇳 Changsha, China

Investigational Site Number 156023; 🇨🇳 Chenzhou, China

Investigational Site Number 156026; 🇨🇳 Guangzhou, China

Investigational Site Number 156029; 🇨🇳 Haikou, China

Investigational Site Number 156028; 🇨🇳 Haikou, China

Investigational Site Number 156040; 🇨🇳 Haikou, China

Investigational Site Number 156039; 🇨🇳 Hangzhou, China

Investigational Site Number 156038; 🇨🇳 Hangzhou, China

Investigational Site Number 156042; 🇨🇳 Hangzhou, China

Investigational Site Number 156044; 🇨🇳 Hangzhou, China

Investigational Site Number 156048; 🇨🇳 Hefei, China

Investigational Site Number 156050; 🇨🇳 Hefei, China

Investigational Site Number 156011; 🇨🇳 Kunming, China

Investigational Site Number 156052; 🇨🇳 Kunming, China

Investigational Site Number 156016; 🇨🇳 Lanzhou, China

Investigational Site Number 156041; 🇨🇳 Lishui, China

Investigational Site Number 156018; 🇨🇳 Nanchang, China

Investigational Site Number 156019; 🇨🇳 Nanchang, China

Investigational Site Number 156031; 🇨🇳 Nanjing, China

Investigational Site Number 156036; 🇨🇳 Shanghai, China

Investigational Site Number 156047; 🇨🇳 Shanghai, China

Investigational Site Number 156027; 🇨🇳 Shantou, China

Investigational Site Number 156015; 🇨🇳 Shenyang, China

Investigational Site Number 156054; 🇨🇳 Shijiazhuang, China

Investigational Site Number 156007; 🇨🇳 Tangshan, China

Investigational Site Number 156010; 🇨🇳 Tianjin, China

Investigational Site Number 156055; 🇨🇳 Wuhan, China

Investigational Site Number 156037; 🇨🇳 Xuzhou, China

Investigational Site Number 156033; 🇨🇳 Yangzhou, China

Investigational Site Number 156030; 🇨🇳 Yueyang, China

Investigational Site Number 156032; 🇨🇳 Zhenjiang, China

Investigational Site Number 156025; 🇨🇳 Zhuzhou, China

Investigational Site Number 156006; 🇨🇳 Beijing, China

Investigational Site Number 156034; 🇨🇳 Changzhou, China

Investigational Site Number 156035; 🇨🇳 Shanghai, China

Investigational Site Number 156043; 🇨🇳 Nanjing, China

Investigational Site Number 156049; 🇨🇳 Nanjing, China