Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
3期
已完成
NCT03353350
| 适应症 | Type 2 Diabetes Mellitus |
|---|
| 分期 | 3期 |
|---|
| 申办方 | Hanmi Pharmaceutical Company Limited |
|---|
| 状态 | 已完成 |
|---|
| 受试者人数 | 406 人 |
|---|
| 干预（药物） | efpeglenatide (SAR439977) |
|---|
| 开始日期 | 2017年12月5日 |
|---|
| 完成日期 | 2020年1月29日 |
|---|
| 结果公布日 | 2022年1月18日 |
|---|
摘要
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 Mellitus) inadequately controlled with diet and exercise. Secondary Objectives: * To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on glycemic control * To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on body weight * To evaluate the safety of once-weekly injection of efpeglenatide
Change in Glycated Hemoglobin (HbA1c) (%)
Baseline to Week 30 · HbA1c (%)
| Placebo | -0.46 ± 1.16 HbA1c (%) |
|---|
| Efpeglenatide 2 mg | -1.14 ± 0.96 HbA1c (%) |
|---|
| Efpeglenatide 4 mg | -1.48 ± 1.01 HbA1c (%) |
|---|
| Efpeglenatide 6 mg | -1.59 ± 1.04 HbA1c (%) |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。