Phase 4
Completed N=929
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
Source: ClinicalTrials.gov NCT02738151 ↗Enrolled (actual)
929
Serious AEs
4.4%
Results posted
Sep 2018
Primary outcomePrimary: Change From Baseline in HbA1c to Week 24 — -1.64; -1.59 percentage of HbA1c — p=<.0001
◆ Published Evidence
Highly cited
198citations · ~25 / year
More Similarities Than Differences Testing Insulin Glargine 300 Units/mL Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial.
Summary
Primary Objective:
To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24.
Secondary Objectives:
Change From Baseline in HbA1c to Week 12
To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12 and week 24 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 participants reaching HbA1c targets <7% or ≤6.5%;
* Percentage of participants reaching HbA1c targets <7% or ≤6.5% without severe and/or confirmed hypoglycemia
* 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).
Percentage of participants requiring rescue therapy.
Linked Publications
-
More Similarities Than Differences Testing Insulin Glargine 300 Units/mL Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c to Week 24 |
-1.64; -1.59 | <.0001 sig |
| SECONDARY Change From Baseline in HbA1c to Week 12 |
-1.37; -1.39 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24 |
-3.64; -3.89; -3.52; -3.95 | — |
| SECONDARY Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24 |
-3.26; -3.25; -3.23; -3.29 | — |
| SECONDARY Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point |
-2.77; -2.28; -3.42; -3.00; -3.20; -3.23 | — |
| SECONDARY Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point |
-3.41; -2.97; -2.63; -2.44; -2.03; -1.92 | — |
| SECONDARY Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24 |
-2.57; -2.50; -2.62; -2.53 | — |
| SECONDARY Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24 |
2.38; 2.62; 1.49; 1.97 | — |
| SECONDARY Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24 |
4.08; 4.73; 3.70; 3.95 | — |
| SECONDARY Percentage of Participants Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24 |
34.63; 36.15; 11.47; 14.29; 48.70; 44.59 | — |
| SECONDARY Percentage of Participants Reaching Target HbA1c <7% and =<6.5% at Week 12 and Week 24 Without Severe and/or Confirmed Hypoglycemia (70 mg/dL) Event |
16.45; 13.64; 4.11; 4.55; 13.42; 12.99 | — |
| SECONDARY Percentage of Participants With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia During 24 Weeks Treatment Period |
4.98; 4.76 | — |
| SECONDARY Percentage of Participants Requiring a Rescue Therapy During 24 Weeks Treatment Period |
1.30; 1.30 | — |
| SECONDARY Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24 |
0.289; 0.255; 0.357; 0.309 | — |
| SECONDARY Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study Period |
53.0; 58.4; 57.2; 57.4; 70.1; 71.2 | — |
| SECONDARY Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study Period |
18.4; 21.0; 22.7; 21.2; 31.2; 30.3 | — |
| SECONDARY Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Participant Year During Study Period |
8.93; 11.31; 11.28; 11.60; 10.09; 11.45 | — |
| SECONDARY Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per Participant Year During Study Period |
1.65; 2.36; 2.32; 2.39; 1.98; 2.38 | — |
Eligibility Criteria
Inclusion criteria
- Adult participants 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 10.5% (at screening visit). Body mass index (BMI) 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.
- Participant 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 safety of participant, 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 participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT02738151) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.