Safety and Efficacy of THR-1442 Compared to Dapagliflozin as Add-on Therapy to Metformin in T2DM

NCT05159882 | Unknown Phase 3

• 1 other identifier: THR-1442-C-606
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to investigate the effect of THR-1442 compared to Dapagliflozin as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).

Conditions

T2DM

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c at Week 24

  HbA1c was obtained at baseline and at Week 24

  Baseline to week 24

Secondary Outcomes (3)

• Change From Baseline in FPG at Week 24

  Baseline, up to 24 weeks

• Change in Body Weight From Baseline to Week 24

  Baseline, up to 24 weeks

• Changes in blood pressure from baseline to week 24

  Baseline, up to 24 weeks

Study Arms (2)

THR-1442 20mg

EXPERIMENTAL

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

Dapagliflozin10mg

ACTIVE COMPARATOR

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

Interventions

THR-1442 and Dapagliflozin placebo DRUG

THR-1442 tablets 20mg and Dapagliflozin tablets placebo

THR-1442 20mg

Dapagliflozin 10mg and THR1442 placebo DRUG

Dapagliflozin tablets 10mg and THR-1442 tablets placebo

Dapagliflozin10mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Newsoara Biopharma Co., Ltd.: lead

Study Sites (6)

The Fourth Hospital of Harbin Medical University

Harbin, Heilongjiang, China

RECRUITING

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

RECRUITING

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Shandong Province Qianfoshan Hospital

Jinan, Shandong, China

RECRUITING

Affiliated Huzhou Hospital Zhejiang University School of Medical

Huzhou, Zhejiang, China

RECRUITING

China-Japan Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

dapagliflozin

Central Study Contacts

Owen Zhang

CONTACT

8621-52998027; owen.zhang@newsoara.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Dapagliflozin tablets, 10mg; Double Blind; Each subject will receive Dapagliflozin (active tablet) once daily for the duration of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: THR-1442 tablets, 20 mg; Double-Blind; Each subject will receive THR-1442, 20 mg once daily for the duration of the study.

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 16, 2021
• Study Start: April 15, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 16, 2021

Record last verified: 2021-11

Locations

CN (6)