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

CTTQ

Status and phase: Unknown; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Linagliptin blank analog tablet; Drug: TQ-F3083 capsule 10 mg; Drug: Linagliptin tablet; Drug: TQ-F3083 blank analog capsule; Drug: TQ-F3083 capsule 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03986073

TQ-F3083-II-01

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

Low dose group

Experimental group

Description:

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.

Treatment:

Drug: Linagliptin blank analog tablet

Drug: TQ-F3083 capsule 10 mg

Drug: TQ-F3083 blank analog capsule

Drug: TQ-F3083 blank analog capsule

High dose group

Experimental group

Description:

Subjects in the high dose group administrated twoTQ-F3083 capsules 20mg and one Linagliptin blank analog tablet orally, once daily for 12 weeks.

Treatment:

Drug: Linagliptin blank analog tablet

Drug: TQ-F3083 capsule 20 mg

Positive drug control group

Active Comparator group

Description:

Subjects in the positive drug control group administrated two TQ-F3083 blank analog capsules and one Linagliptin tablet orally, once daily for 12 weeks.

Treatment:

Drug: TQ-F3083 blank analog capsule

Drug: Linagliptin tablet

Drug: TQ-F3083 blank analog capsule

Placebo group

Placebo Comparator group

Description:

Subjects in the placebo group administrated two TQ-F3083 blank analog capsules and one Linagliptin blank analog tablet orally, once daily for 12 weeks.

Treatment:

Drug: Linagliptin blank analog tablet

Drug: TQ-F3083 blank analog capsule

Drug: TQ-F3083 blank analog capsule