Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGTQ-F3083 capsule 10 mg
Subjects in the low dose group administrated TQ-F3083 capsule 10mg, once daily for 12 weeks.
DRUGTQ-F3083 capsule 20 mg
Subjects in the high dose group administrated TQ-F3083 capsule 20 mg, once daily for 12 weeks.
DRUGTQ-F3083 blank analog capsule
Subjects administrated one TQ-F3083 blank analog capsule orally, once daily for 12 weeks.
DRUGLinagliptin blank analog tablet
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.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycosylated hemoglobin (HbA1c) | up to approximately 15 weeks | Changes in HbA1c compared with baseline after 12 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Fasting plasma glucose (FPG) | up to approximately 15 weeks | Changes in FPG compared with baseline after 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 |
| 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 |
| HbA1c | up to approximately 15 weeks | The proportion of patients with HbA1c less than 7% after 12 weeks of treatment |
Countries
China
Contacts
Primary ContactNanwei Tong, Doctor
Outcome results
None listed