NCT02545842

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

Titration Target for Chinese Type 2 Diabetes Mellitus Patients Using Insulin Glargine to Achieve Glycaemic Goals: An Assessment of Three Different Fasting Plasma Glucose Targets - BEYOND III/FPG GOAL Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 947 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	INSULIN GLARGINE	Pharmaceutical form: solution Route of administration: subcutaneous

Timeline

• Start date: 2015-09-07
• Primary completion: 2018-04-20
• Completion: 2018-04-20
• First posted: 2015-09-10
• Last updated: 2022-04-25

Locations

44 sites across 1 country: China