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.
Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 2 | Drug: Trelagliptin Succinate Drug: Placebo Oral Tablet | Phase 3 |
The trial was divided into a test group and a placebo group: the test group was given trelagliptin succinate tablets, and the placebo group was given placebo. The test group and the placebo group 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.
All subjects were asked to continue their current diabetes diet and physical activity treatment plan throughout the study period.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 254 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Trelagliptin Succinate Monotherapy for Type 2 Diabetes |
Actual Study Start Date : | July 8, 2019 |
Actual Primary Completion Date : | December 3, 2020 |
Actual Study Completion Date : | December 28, 2020 |
Arm | Intervention/treatment |
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Experimental: Trelagliptin succinate 100 mg
Tablets,100mg per tablet,oral, once a week, 100mg each time, continuous medication for a total of 24 weeks
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Drug: Trelagliptin Succinate
the experimental group will use trelagliptin succinate 100 mg for 24weeks
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Placebo Comparator: Placebo Oral Tablet
Tablets,N/A,oral, once a week, one tablet each time, continuous medication for a total of 24 weeks
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Drug: Placebo Oral Tablet
the placebo Comparator groups use placebo oral tablet for 24weeks
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
One of the following conditions:
Exclusion Criteria:
China, Beijing | |
Beijing Hospital | |
Beijing, Beijing, China |
Study Chair: | yueying peng | Clinical Medicine Department CSPC R&D Business Division |
Tracking Information | |||||
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First Submitted Date ICMJE | April 15, 2019 | ||||
First Posted Date ICMJE | May 7, 2019 | ||||
Last Update Posted Date | January 12, 2021 | ||||
Actual Study Start Date ICMJE | July 8, 2019 | ||||
Actual Primary Completion Date | December 3, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
HbA1c [ Time Frame: Baseline, week 24 ] Changes in HbA1c compared to baseline at week 24
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Clinical Trial of Trelagliptin Succinate Tablets in the Treatment of Type 2 Diabetes | ||||
Official Title ICMJE | A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Trelagliptin Succinate Monotherapy for Type 2 Diabetes | ||||
Brief 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. |
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Detailed Description |
The trial was divided into a test group and a placebo group: the test group was given trelagliptin succinate tablets, and the placebo group was given placebo. The test group and the placebo group 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. All subjects were asked to continue their current diabetes diet and physical activity treatment plan throughout the study period. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Diabetes Mellitus, Type 2 | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
254 | ||||
Original Estimated Enrollment ICMJE |
240 | ||||
Actual Study Completion Date ICMJE | December 28, 2020 | ||||
Actual Primary Completion Date | December 3, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03940183 | ||||
Other Study ID Numbers ICMJE | CSPC/HC1425/201801 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||||
Study Sponsor ICMJE | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||||
Verification Date | June 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |