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

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ClinicalTrials.gov Identifier: NCT03986073
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: TQ-F3083 capsule 5 mg Drug: TQ-F3083 capsule 10 mg Drug: TQ-F3083 blank analog capsule Drug: Linagliptin blank analog tablet Drug: Linagliptin tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low dose group
Subjects in the low dose group administrated TQ-F3083 capsule 5mg, one TQ-F3083 blank analog capsule and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
Drug: TQ-F3083 capsule 5 mg
Subjects in the low dose group administrated TQ-F3083 capsule 5mg, 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: 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 TQ-F3083 capsule 10mg and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
Drug: TQ-F3083 capsule 10 mg
Subjects in the high dose group administrated TQ-F3083 capsule 10 mg, once daily for 12 weeks.

Drug: Linagliptin blank analog tablet
Subjects administrated one Linagliptin blank analog tablet orally, 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 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 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.




Primary Outcome Measures :
  1. Glycosylated hemoglobin (HbA1c) [ Time Frame: up to approximately 15 weeks ]
    Changes in HbA1c compared with baseline after 12 weeks of treatment


Secondary Outcome Measures :
  1. Fasting plasma glucose (FPG) [ Time Frame: up to approximately 15 weeks ]
    Changes in FPG compared with baseline after 12 weeks of treatment

  2. 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

  3. Weight [ Time Frame: up to approximately 7, 11, 15 weeks ]
    Changes in weight compared with baseline after 4, 8, 12 weeks of treatment

  4. HbA1c [ Time Frame: up to approximately 15 weeks ]
    The proportion of patients with HbA1c less than 7% after 12 weeks of treatment

  5. HbA1c [ Time Frame: up to approximately 15 weeks ]
    The proportion of patients with HbA1c reduced at least 0.5% after 12 weeks of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986073


Contacts
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Contact: Nanwei Tong, Doctor 18980601196 tongnw@scu.edu.cn

Locations
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China, Chongqing
The Second Affiliated Hospital of Chongqing Medical Uversity Not yet recruiting
Chongqing, Chongqing, China, 400010
Contact: Gangyi Yang, Doctor    13637796061    gangyiyang@163.com   
Chongqing General Hospital, UCAS Not yet recruiting
Chongqing, Chongqing, China, 400013
Contact: Song Lu, Bachelor    13996069207    1516zzy@163.com   
China, Guangdong
The Third Affiliated Hospital of Sun Yat-Sen University Not yet recruiting
Guangzhou, Guangdong, China, 510630
Contact: Bin Yao, Master    18922103583    Bin@medmail.com.cn   
China, Guangxi
The First Affiliated Hospital of Guangxi Medical University Not yet recruiting
Nanning, Guangxi, China, 530021
Contact: Hong Liu, Master    13977191880    Hongmm1@qq.com   
China, Hunan
Xiangya Hospital Central South University Not yet recruiting
Changsha, Hunan, China, 410008
Contact: Minxiang Lei, Doctor    13875873210    xyyynfm618@163.com   
China, Sichuan
West China Hospital of Sichuan University Not yet recruiting
Chengdu, Sichuan, China, 610041
Contact: Nanwei Tong, Doctor    18980601196    tongnw@scu.edu.cn   
China, Yunnan
The First People's Hospital of Yunnan Province Not yet recruiting
Kunming, Yunnan, China, 650032
Contact: Heng Su, Doctor    13759143562    Su_hen@hotmail.com   
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT03986073     History of Changes
Other Study ID Numbers: TQ-F3083-II-01
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action