Study of TQ-F3083 Capsules in Subjects With Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: TQ-F3083 capsule 10 mgDrug: TQ-F3083 capsule 20 mgDrug: TQ-F3083 blank analog capsule
- Registration Number
- NCT03986073
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dose group Linagliptin blank analog tablet Subjects 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. Positive drug control group Linagliptin tablet Subjects 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 Linagliptin blank analog tablet Subjects in the placebo group administrated two TQ-F3083 blank analog capsules and one Linagliptin blank analog tablet orally, once daily for 12 weeks. High dose group Linagliptin blank analog tablet Subjects in the high dose group administrated twoTQ-F3083 capsules 20mg and one Linagliptin blank analog tablet orally, once daily for 12 weeks. Low dose group TQ-F3083 blank analog capsule Subjects 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. Low dose group TQ-F3083 capsule 10 mg Subjects 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. Positive drug control group TQ-F3083 blank analog capsule Subjects 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 TQ-F3083 blank analog capsule Subjects in the placebo group administrated two TQ-F3083 blank analog capsules and one Linagliptin blank analog tablet orally, once daily for 12 weeks. High dose group TQ-F3083 capsule 20 mg Subjects in the high dose group administrated twoTQ-F3083 capsules 20mg and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Glycosylated hemoglobin (HbA1c) up to approximately 15 weeks Changes in HbA1c compared with baseline after 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method Fasting plasma glucose (FPG) up to approximately 15 weeks Changes in FPG compared with baseline after 12 weeks of treatment
HbA1c up to approximately 15 weeks The proportion of patients with HbA1c reduced at least 0.5% after 12 weeks of treatment
GLP-1 (glucagon-like peptide-1) baseline up to 4, 8, 12 weeks changes in DPP-4 activity GLP-1 concentrations compared with baseline after 4, 8, 12 weeks of treatment
2 hours-postprandial blood sugar (2h-PPG） up to approximately 15 weeks Changes in 2h-PPG compared with baseline after 12 weeks of treatment
Weight up to approximately 7, 11, 15 weeks Changes in weight compared with baseline after 4, 8, 12 weeks of treatment
DPP-4 activity ( dipeptidyl peptidase-4) baseline up to 4, 8, 12 weeks changes in DPP-4 activity compared with baseline after 4, 8, 12 weeks of treatment
Trial Locations
- Locations (9)
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The Third Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Jincheng Geberal Hospital
🇨🇳Jincheng, Shanxi, China
The Second Affiliated Hospital of Chongqing Medical Uversity
🇨🇳Chongqing, Chongqing, China
The First People's Hospital of Yunnan Province
🇨🇳Kunming, Yunnan, China
Yuncheng Central Hospital
🇨🇳Jinan, Shandong, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Chongqing General Hospital, UCAS
🇨🇳Chongqing, Chongqing, China