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Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy

CompletedPhase 4

Sponsor: Sanofi

Conditions: Type 2 Diabetes Mellitus

Interventions: INSULIN GLARGINE (HOE901), Insulin Glulisine, Biphasic insulin aspart 30, Repaglinide, Acarbose

Countries: China

Primary Objective: To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction from baseline to end of study. The test for superiority can be done if noninferiority is achieved. Secondary Objectives: * To assess efficacy in terms of percentage of patients achieving HbA1c \<7% and HbA1c \<7% without hypoglycemia. * To assess efficacy in terms of percentage of patients achieving fasting plasma glucose (FPG) \<7 mmol/L and FPG \<7 mmol/L without hypoglycemia. * To assess safety in term of occurrence of moderate/severe hypoglycemia. * To assess daily blood glucose (BG) variation. * To assess patient satisfaction.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria :

* Patients with age between 18 and 70 years.
* Hemoglobin A1c\>7.5%, and ≤11%.
* Fasting plasma glucose \>7 mmol/L.
* Fasting C peptide \>1 ng/mL.
* Type 2 diabetes (T2DM) patients with diabetes diagnosis between 2 and 10 years (World Health Organization 1999 T2DM diagnose criteria).
* Continuous treatment with stable doses of metformin (≥1 g/day) and 1 oral antihyperglycemic drug (at least half maximum dose) for more than 3 months prior to screening.
* Body mass index ≥21 kg/m2, and \<40 kg/m2.

Exclusion criteria:

* More than 7 consecutive days of insulin treatment within the 12 months except for acute disease or surgery.
* Diabetes other than T2DM (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake).
* History of hypoglycemia unawareness or recurrent hypoglycemia or severe hypoglycemia within the past 12 months.
* History of sensitivity to the study drugs or to drugs with a similar chemical structure.
* Pregnancy or planned pregnancy or current lactation (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method).
* Acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma) within the past 12 months.
* Significant diabetic complications and serious disease, e.g., symptomatic autonomic neuropathy, gastroparesis, unstable angina or active proliferative retinopathy.
* Acute infections which may affect BG control within the past 4 weeks.
* Active liver disease, alanine transaminase (ALT) and/or aspartate aminotransferase (AST) greater than two times the upper limit of the reference range at screening.
* Impaired renal function, defined as but not limited to, serum creatinine levels ≥1.5 mg/dL (132 μmol/L) for males and ≥1.4 mg/dL (123 μmol/L) for females or presence of macroproteinuria (\>2 g/day).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (1)

China, China