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

Type 2 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359837
• Other study ID #: LANTUL07194
• Secondary ID: U1111-1186-3400
• Status: Completed
• Phase: Phase 4
• Start date: January 20, 2018
• Est. completion date: June 29, 2020

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: June 29, 2020
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• INSULIN GLARGINE (HOE901)
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
• Insulin Glulisine
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
• Biphasic insulin aspart 30
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
• Repaglinide
Pharmaceutical form: tablet Route of administration: oral administration
• Acarbose
Pharmaceutical form: tablet Route of administration: oral administration
• Metformin
Pharmaceutical form: tablet or capsule Route of administration: oral administration

Locations

Country	Name	City	State
China	CHINA	China

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin A1c (HbA1c)	Change in HbA1c from baseline to week 24	Baseline to Week 24
Secondary	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	At Week 12 and Week 24
Secondary	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	At Week 12 and Week 24
Secondary	Patients with FPG <7 mmol/L	Percentage of patients with FPG <7 mmol/L at week 12 and week 2	At Week 12 and Week 24
Secondary	Patients with FPG <7 mmol/L without hypoglycemia	Percentage of patients with FPG <7 mmol/L without hypoglycemia at week 12 and week 24	At Week 12 and Week 24
Secondary	Patients with HbA1c <7%	Percentage of patients with HbA1c <7% at week 12 and week 24	At Week 12 and Week 24
Secondary	Patients with HbA1c <7% without hypoglycemia	Percentage of patients with HbA1c <7% without hypoglycemia at week 12 and week 24	At Week 12 and Week 24
Secondary	Hypoglycemic events	Incidence of hypoglycemia during treatment period	Baseline to Week 24
Secondary	Change in FPG	Change in FPG from baseline to week 24	Baseline to Week 24
Secondary	Change in body weight	Change in body weight from baseline to week 24	Baseline to Week 24
Secondary	Insulin dose	Total daily insulin dose at week 24	At Week 24
Secondary	Daily BG variation at week 24	Daily blood glucose (BG) variation at week 24	At Week 24
Secondary	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.	Baseline to Week 24
Secondary	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	At week 24