NCT04955834
Recruiting
Phase 3
A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study to Compare the Efficacy and Safety of Insulin Degludec Injection Versus Tresiba® in Subjects With Type 2 Diabetes
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.2 sites in 1 country344 target enrollmentJuly 27, 2021
ConditionsType 2 Diabetes
Overview
- Phase
- Phase 3
- Intervention
- Insulin degludec injection
- Conditions
- Type 2 Diabetes
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 344
- Locations
- 2
- Primary Endpoint
- Change value of glycosylated hemoglobin (HbA1c)
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
This study is a multi-center, randomized, open-label, parallel, positive-controlled registered clinical study,to evaluate the efficacy and safety of insulin degludec injection developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetes (diagnosed clinically) for at least 6 months.
- •Aged ≥18 and ≤70 years old, male or female.
- •Subjects who were treated with a stable dose of oral hypoglycemic agents for more than 3 months before the random visit.
- •HbA1c is in the range of 7.5% -11.0 % by local laboratory analysis.
- •Body mass index (BMI) ≥18 kg/m2 and ≤40kg/m
- •Patients must give informed consent to this study before the trial, and voluntarily sign an informed consent form.
- •Patients who can communicate well with the investigator and can complete the study in accordance with the research regulations.
Exclusion Criteria
- •Diagnosed as type 1 diabetes or other types of diabetes.
- •Patients who have received insulin therapy for more than 7 days within 3 months before screening .
- •Patients who have received a thiazolidinedione (TZD) or GLP-1 receptor agonist within 3 months before screening.
- •Patients who are receiving or have received chronic (lasting more than 2 weeks) systemic glucocorticoid therapy (excluding topical drugs and inhaled preparations) within 3 months before the random visit.
- •Patients who are receiving or have received chronic (lasting more than 2 weeks) systemic glucocorticoid therapy (excluding topical drugs and inhaled preparations) within 3 months before the random visit.
- •Patients with hypoglycemia who have recurring severe events with conscious and/or physical changes within 3 months before screening and need help from others.
- •Those who have experienced acute metabolic complications (ketoacidosis, lactic acidosis, or hyperosmolar coma, etc.) within 3 months before screening.
- •Patients with obvious liver and kidney dysfunction.
- •Hemoglobin \<100g/L.
- •When the virological test during the screening period shows that any of the following is met:
Arms & Interventions
Insulin degludec injection
Insulin degludec injection subcutaneous administration once daily for 26 weeks in combination with Oral antidiabetic drugs (OADs) used before.
Intervention: Insulin degludec injection
Tresiba®
Insulin degludec injection（Tresiba®）subcutaneous administration once daily for 26 weeks in combination with Oral antidiabetic drugs (OADs) used before.
Intervention: Tresiba®
Outcomes
Primary Outcomes
Change value of glycosylated hemoglobin (HbA1c)
Time Frame: Baseline and 26 weeks
Change value of HbA1c from baseline following 26 weeks of therapy
Secondary Outcomes
- Percentage of patients achieving HbA1c ≤7% or HbA1c ≤6.5%(Baseline, week 26)
- Change value of fasting blood glucose(Baseline, week 14, week 26)
- Hypoglycemia(Baseline to week 26)
- Immunogenicity(Baseline, week 14, week 26)
- Change value of HbA1c(Baseline, week 14)
- Adverse events (AEs) and serious adverse events (SAEs)(Baseline to week 26)
- Abnormal findings(Baseline to week 26)
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 4
Phase 4 Trial to Evaluate the Efficacy and Safety of Sancuso Patch in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Highly Emetogenic Chemotherapy (HEC)Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)NCT01659775LG Life Sciences389
Completed
Phase 4
Clinical Study of Treating Type 2 Diabetic Nephropathy With Alfacalcidol and IrbesartanType 2 Diabetic NephropathyNCT03147677The Third Xiangya Hospital of Central South University60
Not yet recruiting
Phase 3
A Clinical Study Comparing Semaglutide Injection and Wegovy® for Weight Management in Obese SubjectsObesityNCT06738979Chia Tai Tianqing Pharmaceutical Group Co., Ltd.408
Recruiting
Phase 3
Study of LY01610 in Patients With Recurrent Small Cell Lung CancerRelapsed Small Cell Lung CancerNCT06128837Luye Pharma Group Ltd.686
Not yet recruiting
Phase 4
Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral MetastasisBreast Cancer Stage IVNCT05860907Fudan University384