Overview

Study of TQ-F3083 Capsules in Subjects With Type 2 Diabetes Mellitus

Status:
Recruiting

Trial end date:
2020-09-30

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Treatments:

Linagliptin

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.