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Completed

NCT Number: NCT03359837

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHINA

China

About this study

The duration of study is approximately 21 months. Each patient will be followed for approximately 27 weeks from screening visit to end-of-study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin glargine (HOE901)

Drug

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Other names: Lantus

insulin glulisine

Drug

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Other names: Apidra

biphasic insulin aspart 30

Drug

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Other names: Novolog Mix70/30

repaglinide

Drug

Pharmaceutical form: tablet

Route of administration: oral administration

Other names: NovoNorm

Acarbose

Drug

Pharmaceutical form: tablet

Route of administration: oral administration

Other names: Glucobay

metformin

Drug

Pharmaceutical form: tablet or capsule

Route of administration: oral administration

Primary outcomes

  1. Change in hemoglobin A1c (HbA1c)

    Time frame: Baseline to Week 24

    Change in HbA1c from baseline to week 24

Secondary outcomes

  1. Patients with fasting plasma glucose (FPG) <6.1 mmol/L

    Time frame: At Week 12 and Week 24

    Percentage of patients with FPG <6.1 mmol/L at week 12 and week 24

  2. Patients with FPG <6.1 mmol/L without hypoglycemia

    Time frame: At Week 12 and Week 24

    Percentage of patients with FPG <6.1 mmol/L without hypoglycemia at week 12 and week 24

  3. Patients with FPG <7 mmol/L

    Time frame: At Week 12 and Week 24

    Percentage of patients with FPG <7 mmol/L at week 12 and week 2

  4. Patients with FPG <7 mmol/L without hypoglycemia

    Time frame: At Week 12 and Week 24

    Percentage of patients with FPG <7 mmol/L without hypoglycemia at week 12 and week 24

  5. Patients with HbA1c <7%

    Time frame: At Week 12 and Week 24

    Percentage of patients with HbA1c <7% at week 12 and week 24

  6. Patients with HbA1c <7% without hypoglycemia

    Time frame: At Week 12 and Week 24

    Percentage of patients with HbA1c <7% without hypoglycemia at week 12 and week 24

  7. Hypoglycemic events

    Time frame: Baseline to Week 24

    Incidence of hypoglycemia during treatment period

  8. Change in FPG

    Time frame: Baseline to Week 24

    Change in FPG from baseline to week 24

  9. Change in body weight

    Time frame: Baseline to Week 24

    Change in body weight from baseline to week 24

  10. Insulin dose

    Time frame: At Week 24

    Total daily insulin dose at week 24

  11. Daily BG variation at week 24

    Time frame: At Week 24

    Daily blood glucose (BG) variation at week 24

  12. European quality of life - 5 dimensions (EQ-5D)

    Time frame: Baseline to Week 24

    Change in quality of life scores from baseline to week 24 on 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is measured at 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problem.

  13. Subgroup analysis

    Time frame: At week 24

    Subgroup analysis of control rate of HbA1c <7% according to duration of diabetes, oral anti-hyperglycemic drug(OAD) treatment and HbA1c at screening, FPG, post prandial glucose(PPG) excursion and C peptide at the beginning of run-in period, insulin dose at end of run-in period

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A 26-Week, Multi-Center, Open-label, Randomized, Parallel-group Study to Evaluate the Efficacy and Safety of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-Term Intensive Insulin Therapy: Basal Insulin Based Treatment (With Prandial OADs Combination) Versus Twice-daily Premixed Insulin

Acronym: SWITCH

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 2, 2017
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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