Phase 3
N=582
iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT05413369 ↗Enrolled (actual)
582
Serious AEs
4.7%
Results posted
Oct 2024
Primary outcome: Primary: Change in HbA1c From Baseline to Week 24: Non-Inferiority Analysis — -1.88; -1.68 percentage of HbA1c — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Insulin glargine/Lixisenatide (Drug); IDegAsp (Drug); Metformin (Drug); SGLT2 inhibitor (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 24: Non-Inferiority Analysis |
-1.88; -1.68 | <0.001 sig |
| SECONDARY Change in HbA1c From Baseline to Week 24: Superiority Analysis |
-1.88; -1.68 | 0.003 sig |
| SECONDARY Change in Body Weight From Baseline to Week 24 |
-0.30; 1.19 | <0.001 sig |
| SECONDARY Percentage of Participants Reaching HbA1c <7% at Week 24 |
72.5; 59.8 | <0.001 sig |
| SECONDARY Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24 |
40.5; 21.3 | <0.001 sig |
| SECONDARY Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24 and no Hypoglycemia During 24-Week Treatment Period |
26.5; 13.4 | <0.001 sig |
| SECONDARY Change in Fasting Plasma Glucose From Baseline to Week 24 |
-3.18; -3.45 | — |
| SECONDARY Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 24 |
-3.36; -2.92 | — |
| SECONDARY Percentage of Participants Reaching HbA1c <7% at Week 24 With no Hypoglycemia During 24-Week Treatment Period |
43.6; 35.7 | — |
| SECONDARY Percentage of Participants Reaching HbA1c <7% at Week 24 With no Clinically Relevant Hypoglycemia During 24-Week Treatment Period |
66.7; 56.0 | — |
| SECONDARY Total Daily Insulin Dose at Week 24 |
27.68; 33.78 | — |
| SECONDARY Percentage of Participants Who Required Rescue Therapy During the 24-Week Treatment Period |
5.2; 6.9 | — |
| SECONDARY Change in Fasting C-Peptide From Baseline to Week 24 |
-0.23; -0.33 | — |
| SECONDARY Number of Participants With Any Hypoglycemia Event During On-Treatment Period |
102; 118 | — |
| SECONDARY Hypoglycemic Event Rate During the On-Treatment Period |
1.90; 2.72 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Adverse Events Of Special Interest (AESIs) and TEAEs Leading to Treatment Discontinuation |
220; 192; 15; 12; 6; 2 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Vital Signs |
1; 1; 4; 7; 0; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology |
4; 1; 1; 4; 25; 19 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry |
6; 9; 0; 0; 0; 0 | — |
Summary
This was a parallel-group treatment, Phase 3, randomized, 2-arm study that assessed the efficacy and safety of iGlarLixi to IDegAsp in Chinese T2DM participants insufficiently controlled with oral antidiabetic drug(s).
Study details included:
* Study duration per participant: approximately up to 27 weeks
* Treatment duration: 24 weeks
* Visit frequency: after screening (an on-site visit), on-site or phone call visit every 1 week from randomization till Week 4, every 2 weeks till week 12 and then every 3 weeks till Week 24 (End of Treatment). There were 14 visits that included 7 phone calls and 7 on-site visits in total during screening and treatment periods. There was a safety follow-up by a phone call visit (End of Study) in 3 days after the last dose of the treatment.
* Health measurement/Observation: change in HbA1c as the primary endpoint.
* Intervention name: iGlarLixi and IDegAsp
* Participant sex: male and female
* Participant age range: adults at least 18 years of age
* Condition/disease: Type 2 diabetes mellitus
Eligibility Criteria
Inclusion Criteria
- Participant had at least 18 of age inclusive, at the time of signing the informed consent.
- Participants who were diagnosed with T2DM for at least 1 year before the screening visit
- Participants who were treated for at least 3 months prior to the screening visit with a stable dose of metformin (at least 1000 mg/day or the maximum tolerated dose) alone or in combination with a second oral antidiabetic treatment that can be a sulfonylurea (SU), a glinide, an alpha-glucosidase inhibitor (alpha-GI), a dipeptidyl-peptidase-4 (DPP-4) inhibitor or a sodium-glucose co-transporter 2 (SGLT-2) inhibitor
- HbA1c at screening visit:
- between 7.5% and 11%, both inclusive, for participants previously treated with metformin alone or + SGLT-2 inhibitor, or
- between 7.0% and 10%, both inclusive, for participants previously treated with metformin + a second oral antidiabetic treatment other than SGLT-2 inhibitor.
- Participants who were overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body mass index (BMI) 3 times the upper limit of normal (ULN) laboratory range.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN.
- Total bilirubin >1.5 ULN (except in case of Gilbert's syndrome).
- Calcitonin ≥20 pg/mL (5.9 pmol/L).
- Hemoglobin <10.5 g/dL and/or neutrophils <1500/mm^3 and/or platelets <100 000/mm^3.
- Positive urine pregnancy test in female of childbearing potential.
- Contraindication to metformin and/or SGLT-2 inhibitor use, for those who were taking it prior to the study, according to local labeling, warning/precaution of use (when appropriate) as displayed in the respective National regulation
- Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
- Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the ICH-GCP Ordinance E6)
- Any specific situation during study implementation/course that may raise ethics considerations
- Sensitivity to any of the study interventions (insulin or, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- Participants who withdrawn consent at randomization or were lost to follow up at randomization visit.
The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT05413369). 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.