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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: INSULIN GLARGINE

Study type: Interventional

Funder types: Industry

Identifiers

NCT02545842

LANTUL07190

U1111-1172-1058 (Other Identifier)

Details and patient eligibility

About

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).

Full description

The study duration for each patient will be 27 weeks.

Enrollment: 947 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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):

  • α-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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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947 participants in 3 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: INSULIN GLARGINE

Group 2

Experimental group

Description:

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

Treatment:

Drug: INSULIN GLARGINE

Group 3

Experimental group

Description:

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

Treatment:

Drug: INSULIN GLARGINE