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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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ClinicalTrials.gov Identifier: NCT03359837
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

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) 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: INSULIN GLARGINE (HOE901) Drug: Insulin Glulisine Drug: Biphasic insulin aspart 30 Drug: Repaglinide Drug: Acarbose Drug: Metformin Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 20, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glargine based therapy
Once daily glargine plus prandial oral anti-hyperglycemic drugs
Drug: INSULIN GLARGINE (HOE901)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Other Name: Lantus

Drug: Insulin Glulisine

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Other Name: Apidra

Drug: Repaglinide

Pharmaceutical form: tablet

Route of administration: oral administration

Other Name: NovoNorm

Drug: Acarbose

Pharmaceutical form: tablet

Route of administration: oral administration

Other Name: Glucobay

Active Comparator: Premixed insulin
Twice daily premixed insulin
Drug: Biphasic insulin aspart 30

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Other Name: Novolog Mix70/30

Drug: Metformin

Pharmaceutical form: tablet or capsule

Route of administration: oral administration





Primary Outcome Measures :
  1. Change in hemoglobin A1c (HbA1c) [ Time Frame: Baseline to Week 24 ]
    Change in HbA1c from baseline to week 24


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359837


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com

Locations
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China
CHINA Recruiting
China, China
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03359837     History of Changes
Other Study ID Numbers: LANTUL07194
U1111-1186-3400 ( Other Identifier: UTN )
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin Aspart
Acarbose
Biphasic Insulins
Insulin glulisine
Repaglinide
Insulin aspart, insulin aspart protamine drug combination 30:70
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action