A Randomized, Double-blind, Placebo-controlled,Parallel-group, Multicenter Study to Evaluate the Effectof Efpeglenatide on Cardiovascular Outcomes in Type 2Diabetes Patients at High Cardiovascular Risk
- Conditions
- -E11 Non-insulin-dependent diabetes mellitusNon-insulin-dependent diabetes mellitusE11
- Registration Number
- PER-017-18
- Lead Sponsor
- Sanofi Aventis Recherche & Development,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 81
Participants are eligible to be included in the study only if all of the following criteria apply:
Age
I 01. Participant must be ≥18 years of age at the time of signing the informed consent.
Type of participant and disease characteristics
I 02. Participants with T2DM and HbA1c >7%
I 03. Participants who meet at least one of the 8 CVD criteria in Table 3 (Review Protocol Section 5.1)
OR
male participants who are ≥50 years of age or female participants who are ≥55 years of
age and have an eGFR ≥25 and <60 mL/min and have at least one of the 6 CV risk factors
listed in Table 4 (Review Protocol Section 5.1)
Sex
I 04. Male or Female
a) Male participants: A male participant must agree to use contraception as detailed in
Appendix 4 (Section 10.4) of this protocol during the intervention period and for at
least 5 weeks after the last dose of study intervention and refrain from donating sperm
during this period.
b) Female participants: A female participant is eligible to participate if she is not pregnant
(see Appendix 4 [Section 10.4]) of this protocol, not breastfeeding, and at least one of the following
conditions applies:
- Not a WOCBP as defined in Appendix 4 (Section 10.4) of this protocol
OR
- A WOCBP who agrees to follow the contraceptive guidance in Appendix 4
(Section 10.4) of this protocol during the intervention period and for at least 5 weeks after the last dose
of study intervention.
Informed Consent
I 05. Capable of giving signed informed consent as described in Appendix 1 (Section 10.1.2) of this protocol
which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Medical conditions
E 01. Clinically relevant history of GI disease associated with prolonged nausea and vomiting,
including (but not limited to) gastroparesis, unstable and uncontrolled gastroesophageal
reflux disease within 6 months prior to screening
E 02. History of pancreatitis (unless pancreatitis was related to gallstone and cholecystectomy
has been performed) and pancreatitis during previous treatment with incretin therapies,
chronic pancreatitis, and pancreatectomy
E 03. Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that
predisposes to MTC (eg, multiple endocrine neoplasia syndromes)
E 04. Estimated glomerular filtration rate <25 mL/min/1.73 m² by the 4 variable Modification of
Diet in Renal Disease (MDRD) equation (at Screening, based on central laboratory)
E 05. Systolic BP >180 mmHg and/or DBP >100 mmHg at randomization
E 06. Hospitalization for hypertensive emergency within 3 months prior to randomization
E 07. Planned coronary revascularization procedures, electrophysiologic device implantation,
cardiac mechanical support implantation or other cardiac surgery
E 08. History of solid organ transplant
E 09. Hypersensitivity to any of the study treatments or any components thereof
E 10. No documented ophthalmologic exam with fundoscopy within 6 months prior to screening
(or within 3 months in patients with severe non proliferative diabetic retinopathy [NPDR]/
proliferative diabetic retinopathy [PDR]/Diabetic Macular Edema [DME])
E 11. Retinopathy or maculopathy with one of the following treatments, either recent (3 months prior to randomization) or planned during the study: intravitreal injections or laser or vitrectomy surgery
E 12. Patients with short life expectancy making implementation of the protocol or interpretation
of the study results difficult in the opinion of the investigator including severe anemia,
congestive heart failure (New York Heart Association [NYHA] III/IV), respiratory,
hepatic, neurological, psychiatric, active malignant tumor or other major systemic disease
E 13. History of drug or alcohol abuse within 6 months prior to the time of screening
Prior/concomitant therapy
E 14. Treated with any GLP-1 RA product (eg, exenatide, liraglutide, lixisenatide, albiglutide,
dulaglutide, semaglutide) within 3 months prior to screening
E 15. Use of any DPP4 inhibitor within 12 weeks prior to screening
E 16. Diabetic treatment has not been stable in the 12 weeks prior to screening, in the opinion of
the investigator
E 17. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for more
than 10 consecutive days within 3 months prior to Screening Visit or for more than
10 consecutive days between Screening and randomization
Prior/concurrent clinical study experience
E 18. Exposure to any investigational drugs in the last 4 weeks or 5 half-lives, whichever is
longer, prior to screening
E 19. Current enrollment in any other clinical study involving an investigational study treatment
E 20. Participation in any previous efpeglenatide/HM11260C clinical trial within 3 months prior
to screening
E 21. Participant is the Investigator or any Subinvestigator, research assistant, pharmacist, study
coordinator, other staff or relative thereof directly involved in the conduct of the protocol
Diagnos
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method