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

• Status: Completed
• Trial end date: 2020-06-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Sanofi
• Treatments: Acarbose; Biphasic Insulins; Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc; Insulin, Isophane; Metformin; Repaglinide

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.