iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, 24 Weeks, Active-controlled, Open-label, 2-arm Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to IDegAsp in Chinese Type 2 Diabetes Mellitus Participants Insufficiently Controlled With Oral Antidiabetic Drug(s)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05413369
• Other study ID #: LPS17396
• Secondary ID: U1111-1267-2772
• Status: Completed
• Phase: Phase 3
• Start date: July 7, 2022
• Est. completion date: October 20, 2023

Study information

• Verified date: January 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a parallel-group treatment, Phase 3, randomized, 2-arm study to assess the efficacy and safety of iGlarLixi to IDegAsp in Chinese T2DM participants insufficiently controlled with oral antidiabetic drug(s).

Study details include:

• 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 will be 14 visits including 7 phone call and 7 on-site visits in total during screening and treatment periods. There will be 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

• Study hypothesis: Compared to IDegAsp, iGlarLixi will demonstrate a similar therapeutic effect on glycemic control assessed by change in HbA1c from baseline to Week 24 in the study participants.

Description:

27 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 582
• Est. completion date: October 20, 2023
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant must be at least 18 of age inclusive, at the time of signing the informed consent.

• Participants who are diagnosed with T2DM for at least 1 year before the screening visit

• Participants who are 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 are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

• Body mass index (BMI) <40 kg/m² at screening

• Male or female, including females of childbearing potential who agree to use contraception during the study duration

• Capable of giving signed informed consent as described in Appendix 1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

• Participant who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²

• Pregnant or breast-feeding woman.

• Woman of childbearing potential not protected by highly effective contraceptive method of birth control and/or who is unwilling or unable to be tested for pregnancy

• Conditions/situations such as:

• Participant with short life expectancy.

• Participant with conditions/concomitant diseases making him/her not evaluable for the primary efficacy endpoint (eg, hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to screening).

• Participant with conditions/concomitant diseases precluding his/her safe participation in this study (eg, active malignant tumor, major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require laser treatment within the study period).

• Uncooperative or any condition that could make the participant potentially non-compliant to the study procedures (e.g., participant unable or unwilling to do self-injections or blood glucose monitoring using the Sponsor-provided blood glucometer at home).

• Previous treatment with insulin (except for short-term treatment =14 days due to intercurrent illness at the discretion of the Investigator) within 1 year prior to screening.

• Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria within 3 months prior to screening.

• Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to screening.

• Use of weight loss drugs within 3 months prior to screening.

• History of discontinuation of a previous treatment with GLP-1 RAs due to safety/tolerability reasons or lack of efficacy.

• Use of any investigational drug other than specified in this protocol within 1 month or 5 half-lives, whichever is longer, prior to screening.

• Laboratory findings tested at the screening visit:

• Amylase and/or lipase >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 withdraw consent at randomization or are loss to follow up at randomization visit.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Insulin glargine/Lixisenatide
solution, by subcutaneous injection
• IDegAsp
solution, by subcutaneous injection
• Metformin
Tablet, orally
• SGLT2 inhibitor
Tablet, orally

Locations

Country	Name	City	State
China	Investigational Site Number : 1560008	Baotou
China	Investigational Site Number : 1560001	Beijing
China	Investigational Site Number : 1560019	Beijing
China	Investigational Site Number : 1560027	Beijing
China	Investigational Site Number : 1560023	Cangzhou
China	Investigational Site Number : 1560046	Changchun
China	Investigational Site Number : 1560059	Changchun
China	Investigational Site Number : 1560052	Changde
China	Investigational Site Number : 1560011	Changsha
China	Investigational Site Number : 1560024	Chengdu
China	Investigational Site Number : 1560054	Chengdu
China	Investigational Site Number : 1560004	Chenzhou
China	Investigational Site Number : 1560044	Chongqing
China	Investigational Site Number : 1560053	Dalian
China	Investigational Site Number : 1560030	Foshan
China	Investigational Site Number : 1560029	Guangzhou
China	Investigational Site Number : 1560043	Guangzhou
China	Investigational Site Number : 1560021	Handan
China	Investigational Site Number : 1560010	Hangzhou
China	Investigational Site Number : 1560025	Harbin
China	Investigational Site Number : 1560045	Harbin
China	Investigational Site Number : 1560056	Huai'an
China	Investigational Site Number : 1560035	Huanggang
China	Investigational Site Number : 1560055	Huangshi
China	Investigational Site Number : 1560038	Huhehaote
China	Investigational Site Number : 1560022	Huizhou
China	Investigational Site Number : 1560051	Huzhou
China	Investigational Site Number : 1560014	Jinan
China	Investigational Site Number : 1560040	Jinan
China	Investigational Site Number : 1560058	Jingzhou
China	Investigational Site Number : 1560041	Kaifeng
China	Investigational Site Number : 1560039	Lanzhou
China	Investigational Site Number : 1560060	Lianyungang
China	Investigational Site Number : 1560031	Luoyang
China	Investigational Site Number : 1560017	Nanjing
China	Investigational Site Number : 1560018	Nanjing
China	Investigational Site Number : 1560028	Nanjing
China	Investigational Site Number : 1560057	Nantong
China	Investigational Site Number : 1560037	Pingxiang
China	Investigational Site Number : 1560048	Qingdao
China	Investigational Site Number : 1560012	Qinhuangdao
China	Investigational Site Number : 1560003	Shanghai
China	Investigational Site Number : 1560006	Shanghai
China	Investigational Site Number : 1560007	Shanghai
China	Investigational Site Number : 1560020	Shanghai
China	Investigational Site Number : 1560009	Shenyang
China	Investigational Site Number : 1560050	Suzhou
China	Investigational Site Number : 1560013	Tianjin
China	Investigational Site Number : 1560016	Tianjin
China	Investigational Site Number : 1560047	Tonghua
China	Investigational Site Number : 1560042	Xingtai
China	Investigational Site Number : 1560015	Xuzhou
China	Investigational Site Number : 1560032	Yueyang
China	Investigational Site Number : 1560033	Yueyang
China	Investigational Site Number : 1560026	Yuncheng
China	Investigational Site Number : 1560049	Zhengzhou
China	Investigational Site Number : 1560034	Zhenjiang
China	Investigational Site Number : 1560036	Zhongshan
China	Investigational Site Number : 1560005	Zhuzhou
China	Investigational Site Number : 1560002	Zigong

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline to Week 24		from baseline to Week 24
Secondary	Change in HbA1c		from baseline to Week 24
Secondary	Change in body weight		from baseline to Week 24
Secondary	Proportion of participants to reach HbA1c<7%		At week 24
Secondary	Proportion of participants reaching HbA1c targets <7% without body weight gain		At week 24
Secondary	Proportion of participants reaching HbA1c < 7% with no body weight gain and no hypoglycemia (defined as ADA Level 1, 2 or 3)		At week 24
Secondary	Change in Fasting plasma glucose		from baseline to week 24
Secondary	Change in 7-point self-monitored plasma glucose (SMPG) profile		from baseline to week 24
Secondary	Proportion of participants reaching HbA1c target <7% with no hypoglycemia (defined as ADA level 1, 2 or 3)		At week 24
Secondary	Proportions of participants reaching HbA1c target < 7% with no clinically relevant hypoglycaemia (defined as ADA level 2 or 3)		At week 24
Secondary	Total insulin dose in each group		At week 24
Secondary	Percentage of participants requiring rescue therapy		During the 24-week treatment period
Secondary	Incidence and Event rates of hypoglycemia (Any, ADA classification level 1, 2, and 3)		from baseline to Week 24
Secondary	Adverse events (AEs), SAEs, adverse events of special interest (AESIs), and AEs leading to treatment discontinuation, vital signs and safety laboratory values		from baseline to Week 24
Secondary	Change in fasting C-peptide		from baseline to Week 24