Study of TQ-F3083 Capsules in Subjects With Type 2 Diabetes Mellitus
A Phase IIA , Multi-center, Randomized, Double-blind, Placebo and Positive Drug Parallel Control Study of TQ-F3083 Capsules With Different Doses in Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
120
1 country
9
Brief Summary
TQ-F3083 capsule is a new type inhibitor of DPP-IV, which is currently a very effective target for the treatment of type 2 diabetes mellitus at clinical. In addition, it can promote insulin secretion with low potential toxicity, and half-life is shorter than Linagliptin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes-mellitus
Started Jan 2020
Shorter than P25 for phase_2 type-2-diabetes-mellitus
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2019
CompletedFirst Posted
Study publicly available on registry
June 14, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedMarch 13, 2020
March 1, 2020
6 months
June 9, 2019
March 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Glycosylated hemoglobin (HbA1c)
Changes in HbA1c compared with baseline after 12 weeks of treatment
up to approximately 15 weeks
Secondary Outcomes (7)
Fasting plasma glucose (FPG)
up to approximately 15 weeks
2 hours-postprandial blood sugar (2h-PPG）
up to approximately 15 weeks
Weight
up to approximately 7, 11, 15 weeks
HbA1c
up to approximately 15 weeks
HbA1c
up to approximately 15 weeks
- +2 more secondary outcomes
Study Arms (4)
Low dose group
EXPERIMENTALSubjects in the low dose group administrated one TQ-F3083 capsule 10mg, one TQ-F3083 blank analog capsule and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
High dose group
EXPERIMENTALSubjects in the high dose group administrated twoTQ-F3083 capsules 20mg and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
Positive drug control group
ACTIVE COMPARATORSubjects in the positive drug control group administrated two TQ-F3083 blank analog capsules and one Linagliptin tablet orally, once daily for 12 weeks.
Placebo group
PLACEBO COMPARATORSubjects in the placebo group administrated two TQ-F3083 blank analog capsules and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
Interventions
Subjects in the low dose group administrated TQ-F3083 capsule 10mg, once daily for 12 weeks.
Subjects in the high dose group administrated TQ-F3083 capsule 20 mg, once daily for 12 weeks.
Subjects administrated one TQ-F3083 blank analog capsule orally, once daily for 12 weeks.
Subjects administrated one Linagliptin blank analog tablet orally, once daily for 12 weeks.
Subjects in the positive drug control group administrated one Linagliptin tablet orally, once daily for 12 weeks.
Eligibility Criteria
You may qualify if:
- Understood and signed an informed consent form; 2.18 and 70 years old; 3.Body mass index (BMI) of 19 to 37.5 kg/m2; 4.Type 2 diabetes mellitus confirmed at least 6 weeks before screen by WHO (1999) diabetes mellitus diagnostic criteria; 5.Has inadequate glycemic control on diet/exercise therapy and irregular use hypoglycemic agents before screening, HbA1c ≥7.0% and ≤10.0% ; Has regular hypoglycemic agents with stable dose within 6 weeks before screening, HbA1c ≥7.0% and ≤9 %; 6.PFG ≤ 13.3 mmol / L; 7. Adequate laboratory inspection standards.
You may not qualify if:
- Has any contraindications, allergies or hypersensitivity for taking research medication ;
- Has used at lest two oral medications to treat diabetes mellitus 6 weeks before screening;
- Has other endocrine-related history or evidence before screening;
- Has history of organ transplantation;
- Has mental or neurological diseases;
- Has received systemic corticosteroids within 2 weeks;
- Has received GLP-1 analogues, DPP-4 inhibitors or anti-obesity drugs 3 months ;
- Has alcohol abuse history within 6 months before screening;
- Has participated in any clinical trial within 3 months;
- Has received blood transfusions, or blood donation ≥ 400 mL , or got severe blood loss ≥ 400 mL within 8 weeks;
- Pregnant or lactating woman.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
The Second Affiliated Hospital of Chongqing Medical Uversity
Chongqing, Chongqing Municipality, 400010, China
Chongqing General Hospital, UCAS
Chongqing, Chongqing Municipality, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2019
First Posted
June 14, 2019
Study Start
January 1, 2020
Primary Completion
June 30, 2020
Study Completion
September 30, 2020
Last Updated
March 13, 2020
Record last verified: 2020-03