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

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.

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.