Back to resultsStudy of TQ-F3083 Capsules in Subjects With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TQ-F3083 capsule 10 mg
TQ-F3083 capsule 20 mg
TQ-F3083 blank analog capsule
TQ-F3083 blank analog capsule
Linagliptin blank analog tablet
Linagliptin tablet
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility 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:
- 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.
Sites / Locations
- The Second Affiliated Hospital of Chongqing Medical Uversity
- Chongqing General Hospital, UCAS
- The Third Affiliated Hospital of Sun Yat-Sen University
- The First Affiliated Hospital of Guangxi Medical University
- Xiangya Hospital Central South University
- Yuncheng Central Hospital
- Jincheng Geberal Hospital
- West China Hospital of Sichuan UniversityRecruiting
- The First People's Hospital of Yunnan Province
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Low dose group
High dose group
Positive drug control group
Placebo group
Arm 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.
Subjects in the high dose group administrated twoTQ-F3083 capsules 20mg and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
Subjects in the positive drug control group administrated two TQ-F3083 blank analog capsules and one Linagliptin tablet orally, once daily for 12 weeks.
Subjects in the placebo group administrated two TQ-F3083 blank analog capsules and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
Outcomes
Primary Outcome Measures
Glycosylated hemoglobin (HbA1c)
Changes in HbA1c compared with baseline after 12 weeks of treatment
Secondary Outcome Measures
Fasting plasma glucose (FPG)
Changes in FPG compared with baseline after 12 weeks of treatment
2 hours-postprandial blood sugar (2h-PPG）
Changes in 2h-PPG compared with baseline after 12 weeks of treatment
Weight
Changes in weight compared with baseline after 4, 8, 12 weeks of treatment
HbA1c
The proportion of patients with HbA1c less than 7% after 12 weeks of treatment
HbA1c
The proportion of patients with HbA1c reduced at least 0.5% after 12 weeks of treatment
DPP-4 activity ( dipeptidyl peptidase-4)
changes in DPP-4 activity compared with baseline after 4, 8, 12 weeks of treatment
GLP-1 (glucagon-like peptide-1)
changes in DPP-4 activity GLP-1 concentrations compared with baseline after 4, 8, 12 weeks of treatment
Full Information
NCT ID
NCT03986073
First Posted
June 9, 2019
Last Updated
March 11, 2020
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03986073
Brief Title
Study of TQ-F3083 Capsules in Subjects With Type 2 Diabetes Mellitus
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low dose group
Arm Type
Experimental
Arm 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.
Arm Title
High dose group
Arm Type
Experimental
Arm Description
Subjects in the high dose group administrated twoTQ-F3083 capsules 20mg and one Linagliptin blank analog tablet orally, once daily for 12 weeks.
Arm Title
Positive drug control group
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
TQ-F3083 capsule 10 mg
Intervention Description
Subjects in the low dose group administrated TQ-F3083 capsule 10mg, once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
TQ-F3083 capsule 20 mg
Intervention Description
Subjects in the high dose group administrated TQ-F3083 capsule 20 mg, once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
TQ-F3083 blank analog capsule
Intervention Description
Subjects administrated one TQ-F3083 blank analog capsule orally, once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
TQ-F3083 blank analog capsule
Intervention Description
Subjects administrated two TQ-F3083 blank analog capsules orally, once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Linagliptin blank analog tablet
Intervention Description
Subjects administrated one Linagliptin blank analog tablet orally, once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Linagliptin tablet
Intervention Description
Subjects in the positive drug control group administrated one Linagliptin tablet orally, once daily for 12 weeks.
Primary Outcome Measure Information:
Title
Glycosylated hemoglobin (HbA1c)
Description
Changes in HbA1c compared with baseline after 12 weeks of treatment
Time Frame
up to approximately 15 weeks
Secondary Outcome Measure Information:
Title
Fasting plasma glucose (FPG)
Description
Changes in FPG compared with baseline after 12 weeks of treatment
Time Frame
up to approximately 15 weeks
Title
2 hours-postprandial blood sugar (2h-PPG）
Description
Changes in 2h-PPG compared with baseline after 12 weeks of treatment
Time Frame
up to approximately 15 weeks
Title
Weight
Description
Changes in weight compared with baseline after 4, 8, 12 weeks of treatment
Time Frame
up to approximately 7, 11, 15 weeks
Title
HbA1c
Description
The proportion of patients with HbA1c less than 7% after 12 weeks of treatment
Time Frame
up to approximately 15 weeks
Title
HbA1c
Description
The proportion of patients with HbA1c reduced at least 0.5% after 12 weeks of treatment
Time Frame
up to approximately 15 weeks
Title
DPP-4 activity ( dipeptidyl peptidase-4)
Description
changes in DPP-4 activity compared with baseline after 4, 8, 12 weeks of treatment
Time Frame
baseline up to 4, 8, 12 weeks
Title
GLP-1 (glucagon-like peptide-1)
Description
changes in DPP-4 activity GLP-1 concentrations compared with baseline after 4, 8, 12 weeks of treatment
Time Frame
baseline up to 4, 8, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nanwei Tong, Doctor
Phone
18980601196
Email
tongnw@scu.edu.cn
Facility Information:
Facility Name
The Second Affiliated Hospital of Chongqing Medical Uversity
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gangyi Yang, Doctor
Email
gangyiyang@163.com
First Name & Middle Initial & Last Name & Degree
Gangyi Yang
Facility Name
Chongqing General Hospital, UCAS
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400013
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song Lu, Bachelor
Email
1516zzy@163.com
First Name & Middle Initial & Last Name & Degree
Song Lu
Facility Name
The Third Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Yao, Master
Email
Bin@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Bin Yao
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Liu, Master
Email
Hongmm1@qq.com
First Name & Middle Initial & Last Name & Degree
Hong Liu
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minxiang Lei, Doctor
Email
xyyynfm618@163.com
First Name & Middle Initial & Last Name & Degree
Minxiang Lei
Facility Name
Yuncheng Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolin Dong, Doctor
Email
13869123309@163.com
First Name & Middle Initial & Last Name & Degree
Xiaolin Dong, Doctor
Facility Name
Jincheng Geberal Hospital
City
Jincheng
State/Province
Shanxi
ZIP/Postal Code
048000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lili Zhang, Doctor
Email
2366787060@qq.com
First Name & Middle Initial & Last Name & Degree
Lili Zhang, Doctor
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nanwei Tong, Doctor
Email
tongnw@scu.edu.cn
First Name & Middle Initial & Last Name & Degree
Nanwei Tong
Facility Name
The First People's Hospital of Yunnan Province
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heng Su, Doctor
Email
Su_hen@hotmail.com
First Name & Middle Initial & Last Name & Degree
Heng Su
12. IPD Sharing Statement
Learn more about this trial
Study of TQ-F3083 Capsules in Subjects With Type 2 Diabetes Mellitus
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