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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

INSULIN GLARGINE (HOE901)

Insulin Glulisine

Biphasic insulin aspart 30

Repaglinide

Acarbose

Metformin

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHINA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glargine based therapy

Premixed insulin

Arm Description

Once daily glargine plus prandial oral anti-hyperglycemic drugs

Twice daily premixed insulin

Outcomes

Primary Outcome Measures

Change in hemoglobin A1c (HbA1c)

Change in HbA1c from baseline to week 24

Secondary Outcome Measures

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

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

Patients with FPG <6.1 mmol/L without hypoglycemia

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

Patients with FPG <7 mmol/L

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

Patients with FPG <7 mmol/L without hypoglycemia

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

Patients with HbA1c <7%

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

Patients with HbA1c <7% without hypoglycemia

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

Hypoglycemic events

Incidence of hypoglycemia during treatment period

Change in FPG

Change in FPG from baseline to week 24

Change in body weight

Change in body weight from baseline to week 24

Insulin dose

Total daily insulin dose at week 24

Daily BG variation at week 24

Daily blood glucose (BG) variation at week 24

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

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.

Subgroup analysis

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

Full Information

NCT ID

NCT03359837

First Posted

November 21, 2017

Last Updated

April 21, 2022

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03359837

Brief Title

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

Acronym

SWITCH

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

January 20, 2018 (Actual)

Primary Completion Date

June 29, 2020 (Actual)

Study Completion Date

June 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

384 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Glargine based therapy

Arm Type

Experimental

Arm Description

Once daily glargine plus prandial oral anti-hyperglycemic drugs

Arm Title

Premixed insulin

Arm Type

Active Comparator

Arm Description

Twice daily premixed insulin

Intervention Type

Drug

Intervention Name(s)

INSULIN GLARGINE (HOE901)

Other Intervention Name(s)

Lantus

Intervention Description

Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Insulin Glulisine

Other Intervention Name(s)

Apidra

Intervention Description

Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Biphasic insulin aspart 30

Other Intervention Name(s)

Novolog Mix70/30

Intervention Description

Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Repaglinide

Other Intervention Name(s)

NovoNorm

Intervention Description

Pharmaceutical form: tablet Route of administration: oral administration

Intervention Type

Drug

Intervention Name(s)

Acarbose

Other Intervention Name(s)

Glucobay

Intervention Description

Pharmaceutical form: tablet Route of administration: oral administration

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Pharmaceutical form: tablet or capsule Route of administration: oral administration

Primary Outcome Measure Information:

Title

Change in hemoglobin A1c (HbA1c)

Description

Change in HbA1c from baseline to week 24

Time Frame

Baseline to Week 24

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

At Week 12 and Week 24

Title

Patients with FPG <6.1 mmol/L without hypoglycemia

Description

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

Time Frame

At Week 12 and Week 24

Title

Patients with FPG <7 mmol/L

Description

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

Time Frame

At Week 12 and Week 24

Title

Patients with FPG <7 mmol/L without hypoglycemia

Description

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

Time Frame

At Week 12 and Week 24

Title

Patients with HbA1c <7%

Description

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

Time Frame

At Week 12 and Week 24

Title

Patients with HbA1c <7% without hypoglycemia

Description

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

Time Frame

At Week 12 and Week 24

Title

Hypoglycemic events

Description

Incidence of hypoglycemia during treatment period

Time Frame

Baseline to Week 24

Title

Change in FPG

Description

Change in FPG from baseline to week 24

Time Frame

Baseline to Week 24

Title

Change in body weight

Description

Change in body weight from baseline to week 24

Time Frame

Baseline to Week 24

Title

Insulin dose

Description

Total daily insulin dose at week 24

Time Frame

At Week 24

Title

Daily BG variation at week 24

Description

Daily blood glucose (BG) variation at week 24

Time Frame

At Week 24

Title

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

Description

Time Frame

Baseline to Week 24

Title

Subgroup analysis

Description

Time Frame

At week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

CHINA

City

China

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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://vivli.org

Citations:

PubMed Identifier

32130661

Citation

Liu J, Jiang X, Xu B, Wang G, Cui N, Zhang X, Liu J, Mu Y, Guo L. Efficacy and Safety of Basal Insulin-Based Treatment Versus Twice-Daily Premixed Insulin After Short-Term Intensive Insulin Therapy in Patients with Type 2 Diabetes Mellitus in China: Study Protocol for a Randomized Controlled Trial (BEYOND V). Adv Ther. 2020 Apr;37(4):1675-1687. doi: 10.1007/s12325-020-01265-6. Epub 2020 Mar 4.

Results Reference

derived

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

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