Safety and Efficacy of THR-1442 Compared to Dapagliflozin as Add-on Therapy to Metformin in T2DM
NCT ID: NCT05159882
Last Updated: 2021-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
390 participants
INTERVENTIONAL
2021-04-15
2022-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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THR-1442 20mg
Each subject will receive THR-1442 20 mg and Dapagliflozin placebo, once daily for the duration of the study.
THR-1442 and Dapagliflozin placebo
THR-1442 tablets 20mg and Dapagliflozin tablets placebo
Dapagliflozin10mg
Each subject will receive Dapagliflozin 10 mg and THR-1442 placebo, once daily for the duration of the study.
Dapagliflozin 10mg and THR1442 placebo
Dapagliflozin tablets 10mg and THR-1442 tablets placebo
Interventions
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THR-1442 and Dapagliflozin placebo
THR-1442 tablets 20mg and Dapagliflozin tablets placebo
Dapagliflozin 10mg and THR1442 placebo
Dapagliflozin tablets 10mg and THR-1442 tablets placebo
Eligibility Criteria
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Inclusion Criteria
2. If subjects are female of childbearing potential, subjects must be negative on the pregnancy test and abstain from coitus or use effective contraceptive measures during the entire study until 30 days after the investigational product is discontinued
3. Subjects diagnosed with T2DM, with a HbA1c level of 7.5-11% (inclusive) at screening and 7.0-10.5% (inclusive) at enrollment
4. Subjects who are treated with a stable dose of ≥ 1500 mg/day metformin monotherapy along with diet and exercise counseling for at least 8 weeks prior to screening
5. Subjects with a BMI of 19-35kg/m2 (inclusive) at screening
6. If applicable, taking stable doses of treatment for dyslipidemia and/or hypertension for 30 days prior to screening. Subjects who do not need to be treated with dyslipidemia or hypertension by the investigator's judgment are also eligible for the study
Exclusion Criteria
2. Definitive diagnosis of Type 1 diabetes mellitus, maturity-onset diabetes of the young (MODY), or secondary diabetes mellitus
3. Symptoms of diabetes mellitus inadequate control, resulting in the inability to participate in this trial, including but not limited to significant polyuria and polydipsia within 3 months prior to the screening visit and weight loss \> 10%
4. History of urinary tract or genital infection within 6 months prior to screening, or ≥ 3 times of urinary tract or genital infections within 6 months prior to screening that require treatments
5. Two or more consecutive SMBG measures ≥ 250 mg/dL (13.9 mmol/L) prior to randomization (run-in period) accompanied by clinical signs or symptoms of hyperglycemia prior to randomization, including weight loss, blurred vision, increased thirst, increased urination, or fatigue
6. History of diabetic ketoacidosis or hyperosmolar non-ketonic coma within 6 months prior to screening
7. History of severe fracture secondary to osteoporosis
8. Poorly controlled hypertension: blood pressure systolic ≥ 160 mmHg and/or blood pressure diastolic ≥ 100 mmHg
9. Surgical history resulting in unstable weight or scheduled for such surgery during the study period
10. Any unstable endocrine, psychiatric, or rheumatoid disease as assessed by the investigator
11. Possible risk of dehydration or body fluid exhaustion based on the investigator's judgment that may affect the interpretation of efficacy or safety data
12. Currently having or had a history of alcohol or drug abuse within the past 6 months
13. Presence of the following cardiovascular/vascular disorders within 6 months prior to screening:
14. Unstable or rapidly progressive renal disorder
15. Congenital renal glycosuria
16. Major liver disease, including but not limited to hepatitis chronic active and/or significant hepatic function abnormal, including ALT and/or AST ≥ 3 × upper limit of normal (ULN) and/or total bilirubin ≥ 2 × ULN; or medical history of severe hepatobiliary disease; or history of any drug-related hepatotoxicity;
17. Current positive serological test result for infectious hepatitis, including known positivity to hepatitis B surface antigen and hepatitis C antibody
18 Years
ALL
No
Sponsors
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Newsoara Biopharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Shandong Province Qianfoshan Hospital
Jinan, Shandong, China
Affiliated Huzhou Hospital Zhejiang University School of Medical
Huzhou, Zhejiang, China
China-Japan Friendship Hospital
Beijing, , China
Countries
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Central Contacts
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Other Identifiers
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THR-1442-C-606
Identifier Type: -
Identifier Source: org_study_id