| Trial ID: | L5912 |
| Source ID: | NCT03986073
|
| Associated Drug: |
Tq-F3083 Capsule 10 Mg
|
| Title: |
Study of TQ-F3083 Capsules in Subjects With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: TQ-F3083 capsule 10 mg|DRUG: TQ-F3083 capsule 20 mg|DRUG: TQ-F3083 blank analog capsule|DRUG: TQ-F3083 blank analog capsule|DRUG: Linagliptin blank analog tablet|DRUG: Linagliptin tablet
|
| Outcome Measures: |
Primary: Glycosylated hemoglobin (HbA1c), Changes in HbA1c compared with baseline after 12 weeks of treatment, up to approximately 15 weeks | Secondary: Fasting plasma glucose (FPG), Changes in FPG compared with baseline after 12 weeks of treatment, up to approximately 15 weeks|2 hours-postprandial blood sugar (2h-PPGļ¼, Changes in 2h-PPG compared with baseline after 12 weeks of treatment, up to approximately 15 weeks|Weight, Changes in weight compared with baseline after 4, 8, 12 weeks of treatment, up to approximately 7, 11, 15 weeks|HbA1c, The proportion of patients with HbA1c less than 7% after 12 weeks of treatment, up to approximately 15 weeks|HbA1c, The proportion of patients with HbA1c reduced at least 0.5% after 12 weeks of treatment, up to approximately 15 weeks|DPP-4 activity ( dipeptidyl peptidase-4), changes in DPP-4 activity compared with baseline after 4, 8, 12 weeks of treatment, baseline up to 4, 8, 12 weeks|GLP-1 (glucagon-like peptide-1), changes in DPP-4 activity GLP-1 concentrations compared with baseline after 4, 8, 12 weeks of treatment, baseline up to 4, 8, 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-01-01
|
| Completion Date: |
2020-09-30
|
| Results First Posted: |
|
| Last Update Posted: |
2020-03-13
|
| Locations: |
The Second Affiliated Hospital of Chongqing Medical Uversity, Chongqing, Chongqing, 400010, China|Chongqing General Hospital, UCAS, Chongqing, Chongqing, 400013, China|The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, 510630, China|The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China|Xiangya Hospital Central South University, Changsha, Hunan, 410008, China|Yuncheng Central Hospital, Jinan, Shandong, 250000, China|Jincheng Geberal Hospital, Jincheng, Shanxi, 048000, China|West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, China|The First People's Hospital of Yunnan Province, Kunming, Yunnan, 650032, China
|
| URL: |
https://clinicaltrials.gov/show/NCT03986073
|
