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

Launched by HANMI PHARMACEUTICAL COMPANY LIMITED · Nov 21, 2017

Keywords

ClinConnect Summary

Study duration per participant is approximately 65 weeks, including a 3-week screening period, 30 weeks core treatment period, 26 weeks extension treatment period, and 6 weeks safety follow up.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Participants must be at least 18 years of age at the time of signing the informed consent.
• • Participants with T2DM, and treated with diet and exercise.
• • Hemoglobin A1c between 7.0% and 10.0% (inclusive) measured by the central laboratory at Screening.
• 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 or history of surgery affecting gastric emptying.
• • 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.
• • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.