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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03986073
• Other study ID #: TQ-F3083-II-01
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: March 2020
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Nanwei Tong, Doctor
• Phone: 18980601196
• Email: tongnw[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• TQ-F3083 capsule 10 mg
Subjects in the low dose group administrated TQ-F3083 capsule 10mg, once daily for 12 weeks.
• TQ-F3083 capsule 20 mg
Subjects in the high dose group administrated TQ-F3083 capsule 20 mg, once daily for 12 weeks.
• TQ-F3083 blank analog capsule
Subjects administrated one TQ-F3083 blank analog capsule orally, once daily for 12 weeks.
• TQ-F3083 blank analog capsule
Subjects administrated two TQ-F3083 blank analog capsules orally, once daily for 12 weeks.
• Linagliptin blank analog tablet
Subjects administrated one Linagliptin blank analog tablet orally, once daily for 12 weeks.
• Linagliptin tablet
Subjects in the positive drug control group administrated one Linagliptin tablet orally, once daily for 12 weeks.

Locations

Country	Name	City	State
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Chongqing General Hospital, UCAS	Chongqing	Chongqing
China	The Second Affiliated Hospital of Chongqing Medical Uversity	Chongqing	Chongqing
China	The Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	Yuncheng Central Hospital	Jinan	Shandong
China	Jincheng Geberal Hospital	Jincheng	Shanxi
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated hemoglobin (HbA1c)	Changes in HbA1c compared with baseline after 12 weeks of treatment	up to approximately 15 weeks
Secondary	Fasting plasma glucose (FPG)	Changes in FPG compared with baseline after 12 weeks of treatment	up to approximately 15 weeks
Secondary	2 hours-postprandial blood sugar (2h-PPG)	Changes in 2h-PPG compared with baseline after 12 weeks of treatment	up to approximately 15 weeks
Secondary	Weight	Changes in weight compared with baseline after 4, 8, 12 weeks of treatment	up to approximately 7, 11, 15 weeks
Secondary	HbA1c	The proportion of patients with HbA1c less than 7% after 12 weeks of treatment	up to approximately 15 weeks
Secondary	HbA1c	The proportion of patients with HbA1c reduced at least 0.5% after 12 weeks of treatment	up to approximately 15 weeks
Secondary	DPP-4 activity ( dipeptidyl peptidase-4)	changes in DPP-4 activity compared with baseline after 4, 8, 12 weeks of treatment	baseline up to 4, 8, 12 weeks
Secondary	GLP-1 (glucagon-like peptide-1)	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