Status:
COMPLETED
Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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) redu...
Detailed Description
The duration of study is approximately 21 months. Each patient will be followed for approximately 27 weeks from screening visit to end-of-study
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2020
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT03359837
Start Date
January 20 2018
End Date
June 29 2020
Last Update
April 25 2022
Active Locations (1)
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1
CHINA
China, China