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Clinical Trial of Trelagliptin Succinate Tablets in the Treatment of Type 2 Diabetes

NCT03940183 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2021-01-12

No results posted yet for this study

Summary

The trial used a randomized, double-blind, placebo-controlled, superior-effect design, multicenter clinical study.

The trial was divided into a test group and a placebo group,the two groups were randomized in a 1:1 ratio and planned to enroll 240 patients with type 2 diabetes. After 2 weeks of screening, all subjects entered the treatment period,which was 24 weeks, and 1 week period of follow-up.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Trelagliptin Succinate

the experimental group will use trelagliptin succinate 100 mg for 24weeks

DRUG

Placebo Oral Tablet

the placebo Comparator groups use placebo oral tablet for 24weeks

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • yueying peng · Clinical Medicine Department CSPC R&D Business Division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-08
Primary Completion
2020-12-03
Completion
2020-12-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03940183 on ClinicalTrials.gov