Efficacy and Safety of Efpeglenatide Versus Placebo in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-001857-42-PL
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-27
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

-Participants must be at least 18 years of age at the time of signing the informed consent.
-Participants with T2DM, based on the World Health Organization (WHO) diagnosis guideline and treated with diet and exercise.
-Hemoglobin A1c between 7.0% and 10.0% (inclusive) measured by the central laboratory at Screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 640
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

Exclusion Criteria

-Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease within 6 months prior to Screening.
--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.
-Personal or family history of Medullary Thyroidian Cancer (MTC) or genetic conditions that predisposes to MTC (eg multiple endocrine neoplasia syndromes).
--Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months of screening) or planned: intravitreal injections or laser or vitrectomy surgery.
-Body weight change of =5 kg within the last 3 months prior to Screening.
-Systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg at Randomization
-End-stage renal disease as defined by estimated glomerular filtration rate (eGFR , by Modification of Diet in Renal Disease [MDRD]) of <15 mL/min/1.73 m2.
-Laboratory findings at the Screening Visit:
- Alanine aminotransferase (ALT ) or aspartate aminotransferase (AST ) >3 times the upper limit of the normal (ULN ) or total bilirubin >1.5 times the ULN (except in case of documented Gilbert’s syndrome).
- Amylase and/or lipase: >3 times the ULN laboratory range.
- Calcitonin =5.9 pmol/L (20 pg/mL).
-Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to Screening, or planned during study period.
-History of drug or alcohol abuse within 6 months prior to the time of Screening.
-Pregnant (demonstrated by serum pregnancy test at Screening) or breast-feeding women.
-Women of childbearing potential not willing to use highly effective method(s) of birth control during the study period and for at least 5 weeks after the last dose of study intervention.
-Male participant not willing to use contraception endpoints during the study period and for at least 5 weeks after the last dose of study intervention and refrain from donating sperm during this period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified