Efficacy and Safety of Efpeglenatide Versus Placebo in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise(AMPLITUDE-M)
- Conditions
- Type 2 diabetes mellitusMedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2016-001857-42-DE
- Lead Sponsor
- Hanmi Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
-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.
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
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: -To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on glycemic control.<br>-To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on body weight.<br>-To evaluate the safety of once-weekly injection of efpeglenatide.;Primary end point(s): Change in glycated hemoglobin (HbA1c) (%): Change from Baseline to Week 30 in HbA1c (%);Timepoint(s) of evaluation of this end point: Baseline to Week 30;Main 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 Mellitus) inadequately controlled with diet and exercise.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1-Change in HbA1c (%): Change from Baseline to Week 56 in HbA1c (%)<br>2-Change in fasting plasma glucose (FPG): Change from Baseline to Week 30 FPG<br>3-HbA1c <7%: Number of participants with HbA1c <7.0% at Week 30<br>4-Change in body weight: Change from Baseline to Week 30 and to Week 56 in body weight<br>5-Hypoglycemic participants: Number of participants with at least 1 hypoglycemic event during treatment period<br>6- Hypoglycemic events: Number of hypoglycemic events per participant-year during treatment period<br>7- Adverse Events (AEs): Number of participants with AEs;Timepoint(s) of evaluation of this end point: 1-Baseline to Week 56<br>2-Baseline to Week 30<br>3-Week 30<br>4-Baseline to Week 30 - Baseline to Week 56<br>5-6-7- Baseline to Week 56