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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients

NCT03011177

Type2 Diabetes Mellitus

COMPLETED PHASE4

A Study of the Effectiveness and Safety of SP2086 to Treat Type 2 Diabetes

NCT01969357

Type 2 Diabetes

COMPLETED PHASE2

The Efficacy of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase-4 Inhibitor in Type 2 Diabetes Patients With Premix Insulin

NCT03458715

Type2 Diabetes

UNKNOWN PHASE4

Effect of Add-on SGLT2i, TZD, or Combination Therapy in Type 2 Diabetes Patients on DPP4 Inhibitors

NCT07108985

Diabetes Mellitus, Type 2 Hyperglycemia Insulin Resistance

NOT_YET_RECRUITING PHASE4

Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes.

NCT07019012

T2DM

RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low dose group

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.

Group Type EXPERIMENTAL

TQ-F3083 capsule 10 mg

Intervention Type DRUG

Subjects in the low dose group administrated TQ-F3083 capsule 10mg, once daily for 12 weeks.

TQ-F3083 blank analog capsule

Intervention Type DRUG

Subjects administrated one TQ-F3083 blank analog capsule orally, once daily for 12 weeks.

Linagliptin blank analog tablet

Intervention Type DRUG

Subjects administrated one Linagliptin blank analog tablet orally, once daily for 12 weeks.

High dose group

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

Group Type EXPERIMENTAL

TQ-F3083 capsule 20 mg

Intervention Type DRUG

Subjects in the high dose group administrated TQ-F3083 capsule 20 mg, once daily for 12 weeks.

Linagliptin blank analog tablet

Intervention Type DRUG

Subjects administrated one Linagliptin blank analog tablet orally, once daily for 12 weeks.

Positive drug control group

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

Group Type ACTIVE_COMPARATOR

TQ-F3083 blank analog capsule

Intervention Type DRUG

Subjects administrated two TQ-F3083 blank analog capsules orally, once daily for 12 weeks.

Linagliptin tablet

Intervention Type DRUG

Subjects in the positive drug control group administrated one Linagliptin tablet orally, once daily for 12 weeks.

Placebo group

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

Group Type PLACEBO_COMPARATOR

TQ-F3083 blank analog capsule

Intervention Type DRUG

Subjects administrated two TQ-F3083 blank analog capsules orally, once daily for 12 weeks.

Linagliptin blank analog tablet

Intervention Type DRUG

Subjects administrated one Linagliptin blank analog tablet orally, once daily for 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TQ-F3083 capsule 10 mg

Subjects in the low dose group administrated TQ-F3083 capsule 10mg, once daily for 12 weeks.

Intervention Type DRUG

TQ-F3083 capsule 20 mg

Subjects in the high dose group administrated TQ-F3083 capsule 20 mg, once daily for 12 weeks.

Intervention Type DRUG

TQ-F3083 blank analog capsule

Subjects administrated one TQ-F3083 blank analog capsule orally, once daily for 12 weeks.

Intervention Type DRUG

TQ-F3083 blank analog capsule

Subjects administrated two TQ-F3083 blank analog capsules orally, once daily for 12 weeks.

Intervention Type DRUG

Linagliptin blank analog tablet

Subjects administrated one Linagliptin blank analog tablet orally, once daily for 12 weeks.

Intervention Type DRUG

Linagliptin tablet

Subjects in the positive drug control group administrated one Linagliptin tablet orally, once daily for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.