Safety and Efficacy of THR-1442 Compared to Dapagliflozin as Add-on Therapy to Metformin in T2DM
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05159882 |
Recruitment Status : Unknown
Verified November 2021 by Newsoara Biopharma Co., Ltd..
Recruitment status was: Recruiting
First Posted : December 16, 2021
Last Update Posted : December 16, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
T2DM | Drug: THR-1442 and Dapagliflozin placebo Drug: Dapagliflozin 10mg and THR1442 placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 390 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | THR-1442 tablets, 20 mg; Double-Blind; Each subject will receive THR-1442, 20 mg once daily for the duration of the study. |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | Dapagliflozin tablets, 10mg; Double Blind; Each subject will receive Dapagliflozin (active tablet) once daily for the duration of the study. |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Double-Blind, Parallel, Active-Controlled Phase III Study on Metformin Combined With THR-1442 or Dapagliflozin in T2DM |
Actual Study Start Date : | April 15, 2021 |
Estimated Primary Completion Date : | September 30, 2022 |
Estimated Study Completion Date : | September 30, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: THR-1442 20mg
Each subject will receive THR-1442 20 mg and Dapagliflozin placebo, once daily for the duration of the study.
|
Drug: THR-1442 and Dapagliflozin placebo
THR-1442 tablets 20mg and Dapagliflozin tablets placebo |
Active Comparator: Dapagliflozin10mg
Each subject will receive Dapagliflozin 10 mg and THR-1442 placebo, once daily for the duration of the study.
|
Drug: Dapagliflozin 10mg and THR1442 placebo
Dapagliflozin tablets 10mg and THR-1442 tablets placebo |
- Change From Baseline in HbA1c at Week 24 [ Time Frame: Baseline to week 24 ]HbA1c was obtained at baseline and at Week 24
- Change From Baseline in FPG at Week 24 [ Time Frame: Baseline, up to 24 weeks ]FPG was obtained at baseline and at Week 24
- Change in Body Weight From Baseline to Week 24 [ Time Frame: Baseline, up to 24 weeks ]Body Weight was obtained at baseline and at week 24
- Changes in blood pressure from baseline to week 24 [ Time Frame: Baseline, up to 24 weeks ]Blood pressure was obtained at baseline and at week 24
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female adult subjects ≥ 18 years of age
- 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
- Subjects diagnosed with T2DM, with a HbA1c level of 7.5-11% (inclusive) at screening and 7.0-10.5% (inclusive) at enrollment
- 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
- Subjects with a BMI of 19-35kg/m2 (inclusive) at screening
- 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:
- History of diabetes insipidus
- Definitive diagnosis of Type 1 diabetes mellitus, maturity-onset diabetes of the young (MODY), or secondary diabetes mellitus
- 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%
- 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
- 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
- History of diabetic ketoacidosis or hyperosmolar non-ketonic coma within 6 months prior to screening
- History of severe fracture secondary to osteoporosis
- Poorly controlled hypertension: blood pressure systolic ≥ 160 mmHg and/or blood pressure diastolic ≥ 100 mmHg
- Surgical history resulting in unstable weight or scheduled for such surgery during the study period
- Any unstable endocrine, psychiatric, or rheumatoid disease as assessed by the investigator
- Possible risk of dehydration or body fluid exhaustion based on the investigator's judgment that may affect the interpretation of efficacy or safety data
- Currently having or had a history of alcohol or drug abuse within the past 6 months
- Presence of the following cardiovascular/vascular disorders within 6 months prior to screening:
- Unstable or rapidly progressive renal disorder
- Congenital renal glycosuria
- 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;
- Current positive serological test result for infectious hepatitis, including known positivity to hepatitis B surface antigen and hepatitis C antibody
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): NCT05159882
Contact: Owen Zhang | 8621-52998027 | owen.zhang@newsoara.com |
China, Heilongjiang | |
The Fourth Hospital of Harbin Medical University | Recruiting |
Harbin, Heilongjiang, China | |
China, Jiangsu | |
The First People's Hospital of Changzhou | Recruiting |
Changzhou, Jiangsu, China | |
The Second Affiliated Hospital of Nanjing Medical University | Recruiting |
Nanjing, Jiangsu, China | |
China, Shandong | |
Shandong Province Qianfoshan Hospital | Recruiting |
Jinan, Shandong, China | |
China, Zhejiang | |
Affiliated Huzhou Hospital Zhejiang University School of Medical | Recruiting |
Huzhou, Zhejiang, China | |
China | |
China-Japan Friendship Hospital | Recruiting |
Beijing, China |
Responsible Party: | Newsoara Biopharma Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT05159882 |
Other Study ID Numbers: |
THR-1442-C-606 |
First Posted: | December 16, 2021 Key Record Dates |
Last Update Posted: | December 16, 2021 |
Last Verified: | November 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dapagliflozin Sodium-Glucose Transporter 2 Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs |