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

March 11, 2020 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Not yet recruiting
        • The Second Affiliated Hospital of Chongqing Medical Uversity
        • Contact:
        • Principal Investigator:
          • Gangyi Yang
      • Chongqing, Chongqing, China, 400013
        • Not yet recruiting
        • Chongqing General Hospital, UCAS
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Not yet recruiting
        • The Third Affiliated Hospital of Sun Yat-Sen University
        • Contact:
        • Principal Investigator:
          • Bin Yao
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410008
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Contact:
        • Principal Investigator:
          • Minxiang Lei
    • Shandong
      • Jinan, Shandong, China, 250000
        • Not yet recruiting
        • Yuncheng Central Hospital
        • Contact:
        • Principal Investigator:
          • Xiaolin Dong, Doctor
    • Shanxi
      • Jincheng, Shanxi, China, 048000
        • Not yet recruiting
        • Jincheng Geberal Hospital
        • Contact:
        • Principal Investigator:
          • Lili Zhang, Doctor
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
        • Principal Investigator:
          • Nanwei Tong
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Not yet recruiting
        • The First People's Hospital of Yunnan Province
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycosylated hemoglobin (HbA1c)
Time Frame: up to approximately 15 weeks
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)
Time Frame: up to approximately 15 weeks
Changes in FPG compared with baseline after 12 weeks of treatment
up to approximately 15 weeks
2 hours-postprandial blood sugar (2h-PPG）
Time Frame: up to approximately 15 weeks
Changes in 2h-PPG compared with baseline after 12 weeks of treatment
up to approximately 15 weeks
Weight
Time Frame: up to approximately 7, 11, 15 weeks
Changes in weight compared with baseline after 4, 8, 12 weeks of treatment
up to approximately 7, 11, 15 weeks
HbA1c
Time Frame: up to approximately 15 weeks
The proportion of patients with HbA1c less than 7% after 12 weeks of treatment
up to approximately 15 weeks
HbA1c
Time Frame: up to approximately 15 weeks
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)
Time Frame: baseline up to 4, 8, 12 weeks
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)
Time Frame: 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
baseline up to 4, 8, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

June 9, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (Actual)

June 14, 2019

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQ-F3083-II-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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