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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545842
• Other study ID #: LANTUL07190
• Secondary ID: U1111-1172-1058
• Status: Completed
• Phase: Phase 4
• Start date: September 7, 2015
• Est. completion date: April 20, 2018

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The study duration for each patient will be 27 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 947
• Est. completion date: April 20, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria :

• 18 to 65 years old.
• Type 2 diabetes patients insufficient controlled by 1-3 oral anti-hyperglycemic drugs

(OADs) with stable dose at least 3 months:

• If on 1 OAD, provided with the following doses (including but not limited to):
• a-glucosidase inhibitor: 100mg, three times a day (tid);
• metformin: 1.5-2.0 g/day;
• sulphonylureas: sub-maximum (half dose above) to maximum tolerated dose;
• thiazolidinediones: eg. pioglitazone, 30-40 mg/day.
• Besides the medications listed above, if on 1 OAD, others should be maximum tolerated dose allowed in package insert.
• If on 2-3 OADs, any range of dose is acceptable.
• HbA1c >7%, and =10.5%.
• FPG >7 mmol/L.
• Body mass index (BMI) =20 kg/m^2, and =40 kg/m^2.
• Diabetes duration =1 year.
• Physician decides to and the patient is willing to start basal insulin (BI) treatment.
• Willing to join the study and sign the informed consent.

Exclusion criteria:

• Type 1 diabetes patients.
• Patients with acute diabetic complications (including unexplained severe hypoglycemia in the last 6 months).
• Previous treatment with insulin for more than 1 month cumulatively in last 1 year, or treatment with insulin in the last 3 months before the screening.
• Known hypoglycemia unawareness or recurrent hypoglycemia.
• Hypersensitivity to study drug or its excipients.
• Any clinically significant acute major organ or systemic disease, or any other situation judged by the Investigator, that is difficult for the 24 weeks follow-up.
• Pregnancy or breastfeeding women.
• Have any mental disorders, lack self-control or not able to express accurately.
• Involved in another clinical trial simultaneously or within a 1 month before start of trial. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• INSULIN GLARGINE
Pharmaceutical form: solution Route of administration: subcutaneous

Locations

Country	Name	City	State
China	Investigational Site Number 156053	Anshan
China	Investigational Site Number 156001	Beijing
China	Investigational Site Number 156002	Beijing
China	Investigational Site Number 156006	Beijing
China	Investigational Site Number 156013	Changchun
China	Investigational Site Number 156014	Changchun
China	Investigational Site Number 156022	Changde
China	Investigational Site Number 156017	Changsha
China	Investigational Site Number 156034	Changzhou
China	Investigational Site Number 156023	Chenzhou
China	Investigational Site Number 156026	Guangzhou
China	Investigational Site Number 156028	Haikou
China	Investigational Site Number 156029	Haikou
China	Investigational Site Number 156040	Haikou
China	Investigational Site Number 156038	Hangzhou
China	Investigational Site Number 156039	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 156020	Nanchang
China	Investigational Site Number 156031	Nanjing
China	Investigational Site Number 156043	Nanjing
China	Investigational Site Number 156049	Nanjing
China	Investigational Site Number 156035	Shanghai
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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

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