Type 2 Diabetes MellitusPhase 2NCT03986073
Study of TQ-F3083 Capsules in Subjects With Type 2 Diabetes Mellitus
A Phase 2 study testing TQ-F3083 capsule 10 mg, TQ-F3083 capsule 20 mg and TQ-F3083 blank analog capsule in people with Type 2 Diabetes Mellitus, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 9 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- TQ-F3083 capsule 10 mg, TQ-F3083 capsule 20 mg and TQ-F3083 blank analog capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 9 sitesChina
- Study dates
- 1 Jan 2020to 30 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Not yet recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Minxiang Lei, Doctor, xyyynfm618@163.com
Minxiang Lei
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Nanwei Tong, Doctor, tongnw@scu.edu.cn
Nanwei Tong
- Not yet recruiting
The Second Affiliated Hospital of Chongqing Medical Uversity
Chongqing, Chongqing Municipality, 400010
Gangyi Yang, Doctor, gangyiyang@163.com
Gangyi Yang
- Not yet recruiting
Chongqing General Hospital, UCAS
Chongqing, Chongqing Municipality, 400013
Song Lu, Bachelor, 1516zzy@163.com
Song Lu
- Not yet recruiting
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510630
Bin Yao, Master, Bin@medmail.com.cn
Bin Yao
- Not yet recruiting
Yuncheng Central Hospital
Jinan, Shandong, 250000
Xiaolin Dong, Doctor, 13869123309@163.com
Xiaolin Dong, Doctor
- Not yet recruiting
Jincheng Geberal Hospital
Jincheng, Shanxi, 048000
Lili Zhang, Doctor, 2366787060@qq.com
Lili Zhang, Doctor
- Not yet recruiting
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032
Heng Su, Doctor, Su_hen@hotmail.com
Heng Su
- Not yet recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Hong Liu, Master, Hongmm1@qq.com
Hong Liu
About this study
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
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- TQ-F3083 capsule 10 mg, TQ-F3083 capsule 20 mg, TQ-F3083 blank analog capsule, Linagliptin blank analog tablet, Linagliptin tablet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ-F3083 capsule 10 mgDrug
Subjects in the low dose group administrated TQ-F3083 capsule 10mg, once daily for 12 weeks.
TQ-F3083 capsule 20 mgDrug
Subjects in the high dose group administrated TQ-F3083 capsule 20 mg, once daily for 12 weeks.
TQ-F3083 blank analog capsuleDrug
Subjects administrated one TQ-F3083 blank analog capsule orally, once daily for 12 weeks.
TQ-F3083 blank analog capsuleDrug
Subjects administrated two TQ-F3083 blank analog capsules orally, once daily for 12 weeks.
Linagliptin blank analog tabletDrug
Subjects administrated one Linagliptin blank analog tablet orally, once daily for 12 weeks.
Linagliptin tabletDrug
Subjects in the positive drug control group administrated one Linagliptin tablet orally, once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Experimental | 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. Receives: Drug: TQ-F3083 capsule 10 mg; Drug: TQ-F3083 blank analog capsule; Drug: Linagliptin blank analog tablet |
| High dose group | Experimental | Subjects in the high dose group administrated twoTQ-F3083 capsules 20mg and one Linagliptin blank analog tablet orally, once daily for 12 weeks. Receives: Drug: TQ-F3083 capsule 20 mg; Drug: Linagliptin blank analog tablet |
| Positive drug control group | Active comparator | Subjects in the positive drug control group administrated two TQ-F3083 blank analog capsules and one Linagliptin tablet orally, once daily for 12 weeks. Receives: Drug: TQ-F3083 blank analog capsule; Drug: Linagliptin tablet |
| Placebo group | Placebo comparator | Subjects in the placebo group administrated two TQ-F3083 blank analog capsules and one Linagliptin blank analog tablet orally, once daily for 12 weeks. Receives: Drug: TQ-F3083 blank analog capsule; Drug: Linagliptin blank analog tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin (HbA1c)
Changes in HbA1c compared with baseline after 12 weeks of treatment
Measured: up to approximately 15 weeks
Secondary outcomes (7)
Fasting plasma glucose (FPG)
Changes in FPG compared with baseline after 12 weeks of treatment
Measured: up to approximately 15 weeks
2 hours-postprandial blood sugar (2h-PPG）
Changes in 2h-PPG compared with baseline after 12 weeks of treatment
Measured: up to approximately 15 weeks
Weight
Changes in weight compared with baseline after 4, 8, 12 weeks of treatment
Measured: up to approximately 7, 11, 15 weeks
HbA1c
The proportion of patients with HbA1c less than 7% after 12 weeks of treatment
Measured: up to approximately 15 weeks
HbA1c
The proportion of patients with HbA1c reduced at least 0.5% after 12 weeks of treatment
Measured: up to approximately 15 weeks
DPP-4 activity ( dipeptidyl peptidase-4)
changes in DPP-4 activity compared with baseline after 4, 8, 12 weeks of treatment
Measured: baseline up to 4, 8, 12 weeks
GLP-1 (glucagon-like peptide-1)
changes in DPP-4 activity GLP-1 concentrations compared with baseline after 4, 8, 12 weeks of treatment
Measured: baseline up to 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Jan 2020
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986073
- Sponsor's protocol ID
- TQ-F3083-II-01
- Status last verified
- Mar 2020
- First submitted
- 9 Jun 2019
- Last updated
- 13 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03986073
- Acronym / sponsor ID
- TQ-F3083-II-01
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Experimental | Drug: TQ-F3083 capsule 10 mg, Drug: TQ-F3083 blank analog capsule, Drug: Linagliptin blank analog tabletSubjects 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. |
| High dose group | Experimental | Drug: TQ-F3083 capsule 20 mg, Drug: Linagliptin blank analog tabletSubjects in the high dose group administrated twoTQ-F3083 capsules 20mg and one Linagliptin blank analog tablet orally, once daily for 12 weeks. |
| Positive drug control group | Active comparator | Drug: TQ-F3083 blank analog capsule, Drug: Linagliptin tabletSubjects in the positive drug control group administrated two TQ-F3083 blank analog capsules and one Linagliptin tablet orally, once daily for 12 weeks. |
| Placebo group | Placebo comparator | Drug: TQ-F3083 blank analog capsule, Drug: Linagliptin blank analog tabletSubjects in the placebo group administrated two TQ-F3083 blank analog capsules and one Linagliptin blank analog tablet orally, once daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQ-F3083 capsule 10 mgSubjects in the low dose group administrated TQ-F3083 capsule 10mg, once daily for 12 weeks. | Drug | Low dose group |
| TQ-F3083 capsule 20 mgSubjects in the high dose group administrated TQ-F3083 capsule 20 mg, once daily for 12 weeks. | Drug | High dose group |
| TQ-F3083 blank analog capsuleSubjects administrated one TQ-F3083 blank analog capsule orally, once daily for 12 weeks. | Drug | Low dose group |
| TQ-F3083 blank analog capsuleSubjects administrated two TQ-F3083 blank analog capsules orally, once daily for 12 weeks. | Drug | Placebo group, Positive drug control group |
| Linagliptin blank analog tabletSubjects administrated one Linagliptin blank analog tablet orally, once daily for 12 weeks. | Drug | High dose group, Low dose group, Placebo group |
| Linagliptin tabletSubjects in the positive drug control group administrated one Linagliptin tablet orally, once daily for 12 weeks. | Drug | Positive drug control group |
Primary outcome
Glycosylated hemoglobin (HbA1c)
Time frame: up to approximately 15 weeks
Changes in HbA1c compared with baseline after 12 weeks of treatment
7 secondary outcomes
Fasting plasma glucose (FPG)
Time frame: up to approximately 15 weeks
2 hours-postprandial blood sugar (2h-PPG）
Time frame: up to approximately 15 weeks
Weight
Time frame: up to approximately 7, 11, 15 weeks
HbA1c
Time frame: up to approximately 15 weeks
HbA1c
Time frame: up to approximately 15 weeks
DPP-4 activity ( dipeptidyl peptidase-4)
Time frame: baseline up to 4, 8, 12 weeks
GLP-1 (glucagon-like peptide-1)
Time frame: baseline up to 4, 8, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQ-F3083 capsule 10 mg, TQ-F3083 capsule 20 mg and TQ-F3083 blank analog capsule in people with Type 2 Diabetes Mellitus, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nanwei Tong, Doctor (18980601196, tongnw@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated hemoglobin (HbA1c) (time frame: up to approximately 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.