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

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Sanofi

Status and phase

Completed
Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Acarbose
Drug: Metformin
Drug: Repaglinide
Drug: Biphasic insulin aspart 30
Drug: INSULIN GLARGINE (HOE901)
Drug: Insulin Glulisine

Study type

Interventional

Funder types

Industry

Identifiers

NCT03359837
U1111-1186-3400 (Other Identifier)
LANTUL07194

Details and patient eligibility

About

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.

Full 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

Enrollment

384 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

384 participants in 2 patient groups

Glargine based therapy
Experimental group
Description:
Once daily glargine plus prandial oral anti-hyperglycemic drugs
Treatment:
Drug: Insulin Glulisine
Drug: INSULIN GLARGINE (HOE901)
Drug: Repaglinide
Drug: Acarbose
Premixed insulin
Active Comparator group
Description:
Twice daily premixed insulin
Treatment:
Drug: Biphasic insulin aspart 30
Drug: Metformin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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