Clinical trial NCT03986073: Study of TQ-F3083 Capsules in Subjects With Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1.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.

Exclusion Criteria:

1. Has any contraindications, allergies or hypersensitivity for taking research medication ;
2. Has used at lest two oral medications to treat diabetes mellitus 6 weeks before screening;
3. Has other endocrine-related history or evidence before screening;
4. Has history of organ transplantation;
5. Has mental or neurological diseases;
6. Has received systemic corticosteroids within 2 weeks;
7. Has received GLP-1 analogues, DPP-4 inhibitors or anti-obesity drugs 3 months ;
8. Has alcohol abuse history within 6 months before screening;
9. Has participated in any clinical trial within 3 months;
10. Has received blood transfusions, or blood donation ≥ 400 mL , or got severe blood loss ≥ 400 mL within 8 weeks;
11. Pregnant or lactating woman.

Primary outcomes:
measure: Glycosylated hemoglobin (HbA1c)
timeFrame: up to approximately 15 weeks
Secondary outcomes:
measure: Fasting plasma glucose (FPG)
timeFrame: up to approximately 15 weeks
measure: 2 hours-postprandial blood sugar (2h-PPG）
timeFrame: up to approximately 15 weeks
measure: Weight
timeFrame: up to approximately 7, 11, 15 weeks
measure: HbA1c
timeFrame: up to approximately 15 weeks
measure: HbA1c
timeFrame: up to approximately 15 weeks
measure: DPP-4 activity ( dipeptidyl peptidase-4)
timeFrame: baseline up to 4, 8, 12 weeks
measure: GLP-1 (glucagon-like peptide-1)
timeFrame: baseline up to 4, 8, 12 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical Uversity
state: Chongqing
city: Chongqing
country: China
facility: Chongqing General Hospital, UCAS
state: Chongqing
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Jinan
country: China
facility: Yuncheng Central Hospital
state: Shandong
city: Jincheng
country: China
facility: Jincheng Geberal Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
Study officials:
References: