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Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist (BRIGHT)

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ClinicalTrials.gov Identifier: NCT02738151
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change.

Secondary Objectives:

  • To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® on:
  • Change in Fasting plasma glucose (FPG);
  • Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG profile;
  • Percentage of patients reaching HbA1c targets <7% or ≤6.5%;
  • Percentage of patients reaching HbA1c targets <7% or ≤6.5% without severe and/or confirmed hypoglycemia
  • Percentage of patients requiring rescue therapy.
  • To assess the frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes Association (ADA) category of hypoglycemia.
  • To assess the safety in each treatment group.
  • To assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: INSULIN GLARGINE (U300) Drug: Insulin degludec Drug: GLP-1 receptor agonist Drug: Glimepiride Drug: Metformin Phase 4

Detailed Description:
The maximum study duration per patient will be approximately 27 weeks: an up to 2-week screening period, a 24-week randomized treatment period, and a 7-day posttreatment safety follow-up period.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 929 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 24-week, Multicenter, Randomized, Open-label, Parallel-group StudyComparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-NaivePatients With Type 2 Diabetes Mellitus Not Adequately Controlled With OralAntihyperglycemic Drug(s) GLP-1 Receptor Agonist
Study Start Date : May 19, 2016
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : August 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin glargine (U300)

Insulin glargine (U300) is self-administered once daily (OD). Treatment will be initiated and individually adjusted at least weekly according to fasting SMPG target.

Subjects should continue their background noninsulin antidiabetic treatment (oral antihyperglycemic drugs[OADs] and glucagon like peptide-1[GLP-1] receptor agonist) during the study period.

Drug: INSULIN GLARGINE (U300)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: HOE901, Toujeo

Drug: GLP-1 receptor agonist

Pharmaceutical form: solution

Route of administration: subcutaneous


Drug: Glimepiride

Pharmaceutical form: tablet

Route of administration: oral


Drug: Metformin

Pharmaceutical form: tablet

Route of administration: oral


Active Comparator: Insulin degludec

Insulin degludec is self-administered OD. Treatment will be initiated and individually adjusted at least weekly according to fasting SMPG target.

Subjects should continue their background noninsulin antidiabetic treatment (OADs and GLP-1 receptor agonist) during the study period.

Drug: Insulin degludec

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: Tresiba

Drug: GLP-1 receptor agonist

Pharmaceutical form: solution

Route of administration: subcutaneous


Drug: Glimepiride

Pharmaceutical form: tablet

Route of administration: oral


Drug: Metformin

Pharmaceutical form: tablet

Route of administration: oral





Primary Outcome Measures :
  1. Change from baseline in HbA1c [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Change from baseline in HbA1c [ Time Frame: Baseline to Week 12 ]
  2. Change in FPG from baseline [ Time Frame: Baseline to Week 12 and Week 24 ]
  3. Change in fasting self-monitoring plasma glucose (SMPG) from baseline [ Time Frame: Baseline to Week 12 and Week 24 ]
  4. Change in 4-point and 8-point SMPG profiles per time-point from baseline [ Time Frame: Baseline to Week 12 and Week 24 ]
  5. Change of mean 24-hour plasma glucose from baseline [ Time Frame: Baseline to Week 12 and Week 24 ]
  6. Change in variability of fasting SMPG from baseline [ Time Frame: Baseline to Week 12 and Week 24 ]
  7. Change in variability of 24-hour plasma glucose from baseline [ Time Frame: Baseline to Week 12 and Week 24 ]
  8. Percentage (%) of patients reaching target HbA1c <7% and ≤6.5% [ Time Frame: Baseline to Week 12 and Week 24 ]
  9. Percentage (%) of patients reaching target HbA1c <7% and ≤6.5% without severe and/or confirmed hypoglycemia [ Time Frame: Baseline to Week 12 and Week 24 ]
  10. Percentage (%) of patients with sulphonylurea or meglitinide dose reduction due to hypoglycemia [ Time Frame: Baseline to Week 24 ]
  11. Percentage of patients requiring a rescue therapy [ Time Frame: Baseline to Week 24 ]
  12. Change in basal insulin dose (U and U/kg body weight) from baseline [ Time Frame: Baseline to Week 12 and Week 24 ]
  13. Percentage of patients reporting hypoglycemia event per ADA classification [ Time Frame: Baseline to Week 24 ]
  14. Event rate of hypoglycemia per ADA classification [ Time Frame: Baseline to Week 24 ]
  15. Percentage (%) of patients experiencing adverse events [ Time Frame: Baseline to Week 24 ]
  16. Change in Patient Report Outcomes scores [ Time Frame: Baseline to Week 12 and Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Adult patients with type 2 diabetes mellitus (T2DM) inadequately controlled with OADs therapy with/without GLP-1 receptor agonist at stable dose for at least 3 months.
  • Signed written informed consent.

Exclusion criteria:

  • Age <18 years.
  • HbA1c <7.5% or >10.5% (at screening visit). Body mass index (BMI) <25 kg/m^2 or >40 kg/m^2.
  • History of T2DM for less than 1 year before screening.
  • Less than 6 months before screening on OADs treatment and GLP-1 receptor agonist (if taken).
  • Current or previous insulin use except for a maximum of 8 consecutive days or totally 15 days (eg, acute illness, surgery) during the last year prior to screening.
  • Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
  • Patient receiving only noninsulin antihyperglycemic drugs not approved for combination with insulin according to local labelling/local treatment guideline.
  • History of hypoglycemia unawareness or repeated episodes of severe hypoglycemia or metabolic acidosis, including hospitalization for diabetic ketoacidosis during the last 12 months prior to screening.
  • Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period.
  • End stage renal disease.
  • Any acute or chronic condition that in the opinion of Investigator would affect the patient safety, compliance, or study results.
  • Any contraindication to use of Toujeo® or Tresiba® as defined in the national product label, hypersensitivity to Toujeo® or Tresiba® active ingredients or one of the excipients.
  • Pregnant or breast-feeding women.

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): NCT02738151


  Show 158 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02738151     History of Changes
Other Study ID Numbers: LPS14584
2015-005101-36 ( EudraCT Number )
U1111-1177-6327 ( Other Identifier: UTN )
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glimepiride
Insulin
Insulin Glargine
Insulin, Long-Acting
Hypoglycemic Agents
Glucagon-Like Peptide 1
Glucagon
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors