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

• Status: Completed
• Trial end date: 2018-04-20
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

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.