Status:
COMPLETED
Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Collaborating Sponsors:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary Objective: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes M...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2020
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT03353350
Start Date
December 5 2017
End Date
September 7 2020
Last Update
January 18 2022
Active Locations (54)
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1
Investigational Site Number 8400004
Birmingham, Alabama, United States, 35205
2
Investigational Site Number 8400005
Glendale, Arizona, United States, 85306
3
Investigational Site Number 8400003
Canoga Park, California, United States, 91303
4
Investigational Site Number 8400007
Chula Vista, California, United States, 91911