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Type 2 Diabetes MellitusPhase 4SWITCHNCT03359837

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

A Phase 4 study testing INSULIN GLARGINE (HOE901), Insulin Glulisine and Biphasic insulin aspart 30 in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
INSULIN GLARGINE (HOE901), Insulin Glulisine and Biphasic insulin aspart 30
Could I receive a placebo?
No, everyone receives an active treatment
How many people
384 participants
Where
1 siteChina
Study dates
20 Jan 2018to 29 Jun 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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 locations and contacts

1 site in 1 country.

China1 site

  • CHINA

    China

Other trials in China

About this study

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

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.

Read more

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.
Read the 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

Being tested
INSULIN GLARGINE (HOE901), Insulin Glulisine, Biphasic insulin aspart 30, Repaglinide, Acarbose
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INSULIN GLARGINE (HOE901)Drug

    Also called Lantus

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous injection

  • Insulin GlulisineDrug

    Also called Apidra

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous injection

  • Biphasic insulin aspart 30Drug

    Also called Novolog Mix70/30

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous injection

  • RepaglinideDrug

    Also called NovoNorm

    Pharmaceutical form: tablet

    Route of administration: oral administration

  • AcarboseDrug

    Also called Glucobay

    Pharmaceutical form: tablet

    Route of administration: oral administration

  • MetforminDrug

    Pharmaceutical form: tablet or capsule

    Route of administration: oral administration

Study groups in NCT03359837
Study groupRoleWhat they receive
Glargine based therapyExperimentalOnce daily glargine plus prandial oral anti-hyperglycemic drugs
Receives: Drug: INSULIN GLARGINE (HOE901); Drug: Insulin Glulisine; Drug: Repaglinide; Drug: Acarbose
Premixed insulinActive comparatorTwice daily premixed insulin
Receives: Drug: Biphasic insulin aspart 30; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in hemoglobin A1c (HbA1c)

    Change in HbA1c from baseline to week 24

    Measured: Baseline to Week 24

Secondary outcomes (13)

  1. 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

    Measured: At Week 12 and Week 24

  2. 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

    Measured: At Week 12 and Week 24

  3. Patients with FPG <7 mmol/L

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

    Measured: At Week 12 and Week 24

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

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

    Measured: At Week 12 and Week 24

  5. Patients with HbA1c <7%

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

    Measured: At Week 12 and Week 24

  6. Patients with HbA1c <7% without hypoglycemia

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

    Measured: At Week 12 and Week 24

  7. Hypoglycemic events

    Incidence of hypoglycemia during treatment period

    Measured: Baseline to Week 24

  8. Change in FPG

    Change in FPG from baseline to week 24

    Measured: Baseline to Week 24

  9. Change in body weight

    Change in body weight from baseline to week 24

    Measured: Baseline to Week 24

  10. Insulin dose

    Total daily insulin dose at week 24

    Measured: At Week 24

  11. Daily BG variation at week 24

    Daily blood glucose (BG) variation at week 24

    Measured: At Week 24

  12. 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.

    Measured: Baseline to Week 24

  13. 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

    Measured: At week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2017
  2. Study start20 Jan 2018
  3. Primary completion29 Jun 2020
  4. Study completion29 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
384 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03359837
Sponsor's protocol ID
LANTUL07194
Other IDs
U1111-1186-3400
Acronym
SWITCH
Status last verified
Apr 2022
First submitted
21 Nov 2017
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 32130661

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing INSULIN GLARGINE (HOE901), Insulin Glulisine and Biphasic insulin aspart 30 in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in hemoglobin A1c (HbA1c) (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03359837, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.

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