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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: TQ-F3083 capsule 10 mg
* Drug: TQ-F3083 capsule 20 mg
* Drug: TQ-F3083 blank analog capsule
* Drug: TQ-F3083 blank analog capsule
* Drug: Linagliptin blank analog tablet
* Drug: Linagliptin tablet


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose group<br>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. | Drug: TQ-F3083 capsule 10 mg<br>* Subjects in the low dose group administrated TQ-F3083 capsule 10mg, once daily for 12 weeks.<br>Drug: TQ-F3083 blank analog capsule<br>* Subjects administrated one TQ-F3083 blank analog capsule orally, once daily for 12 weeks.<br>Drug: Linagliptin blank analog tablet<br>* Subjects administrated one Linagliptin blank analog tablet orally, once daily for 12 weeks.<br>|
| Experimental: High dose group<br>Subjects in the high dose group administrated twoTQ-F3083 capsules 20mg and one Linagliptin blank analog tablet orally, once daily for 12 weeks. | Drug: TQ-F3083 capsule 20 mg<br>* Subjects in the high dose group administrated TQ-F3083 capsule 20 mg, once daily for 12 weeks.<br>Drug: Linagliptin blank analog tablet<br>* Subjects administrated one Linagliptin blank analog tablet orally, once daily for 12 weeks.<br>|
| Active Comparator: Positive drug control group<br>Subjects in the positive drug control group administrated two TQ-F3083 blank analog capsules and one Linagliptin tablet orally, once daily for 12 weeks. | Drug: TQ-F3083 blank analog capsule<br>* Subjects administrated two TQ-F3083 blank analog capsules orally, once daily for 12 weeks.<br>Drug: Linagliptin tablet<br>* Subjects in the positive drug control group administrated one Linagliptin tablet orally, once daily for 12 weeks.<br>|
| Placebo Comparator: Placebo group<br>Subjects in the placebo group administrated two TQ-F3083 blank analog capsules and one Linagliptin blank analog tablet orally, once daily for 12 weeks. | Drug: TQ-F3083 blank analog capsule<br>* Subjects administrated two TQ-F3083 blank analog capsules orally, once daily for 12 weeks.<br>Drug: Linagliptin blank analog tablet<br>* Subjects administrated one Linagliptin blank analog tablet orally, once daily for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated hemoglobin (HbA1c) | Changes in HbA1c compared with baseline after 12 weeks of treatment | up to approximately 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose (FPG) | Changes in FPG compared with baseline after 12 weeks of treatment | up to approximately 15 weeks | 
| 2 hours-postprandial blood sugar (2h-PPG） | Changes in 2h-PPG compared with baseline after 12 weeks of treatment | up to approximately 15 weeks | 
| Weight | Changes in weight compared with baseline after 4, 8, 12 weeks of treatment | up to approximately 7, 11, 15 weeks | 
| HbA1c | The proportion of patients with HbA1c less than 7% after 12 weeks of treatment | up to approximately 15 weeks | 
| HbA1c | The proportion of patients with HbA1c reduced at least 0.5% after 12 weeks of treatment | up to approximately 15 weeks | 
| DPP-4 activity ( dipeptidyl peptidase-4) | changes in DPP-4 activity compared with baseline after 4, 8, 12 weeks of treatment | baseline up to 4, 8, 12 weeks | 
| GLP-1 (glucagon-like peptide-1) | changes in DPP-4 activity GLP-1 concentrations compared with baseline after 4, 8, 12 weeks of treatment | baseline up to 4, 8, 12 weeks |