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

NCT02545842

CompletedPhase 4

Sponsor: Sanofi

Conditions: Type 2 Diabetes Mellitus

Interventions: INSULIN GLARGINE

Countries: China

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (44)
  • Anshan, China
  • Beijing, China
  • Beijing, China
  • Beijing, China
  • Changchun, China
  • Changchun, China
  • Changde, China
  • Changsha, China
  • Changzhou, China
  • Chenzhou, China
  • Guangzhou, China
  • Haikou, China
  • Haikou, China
  • Haikou, China
  • Hangzhou, China
  • Hangzhou, China
  • Hangzhou, China
  • Hangzhou, China
  • Hefei, China
  • Hefei, China
  • Kunming, China
  • Kunming, China
  • Lanzhou, China
  • Lishui, China
  • Nanchang, China
  • Nanchang, China
  • Nanchang, China
  • Nanjing, China
  • Nanjing, China
  • Nanjing, China
  • + 14 more on CT.gov