A Clinical Study of Insulin Degludec Injection in Subjects With Type 2 Diabetes

Phase 3

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: Tresiba®; Drug: Insulin degludec injection

• Registration Number: NCT04955834
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-05
• Study First Posted: 2021-07-09
• Study Start: 2021-07-27
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-18
• Last Update Posted: 2021-09-21
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 344

Inclusion Criteria

1. Type 2 diabetes (diagnosed clinically) for at least 6 months.
2. Aged ≥18 and ≤70 years old, male or female.
3. Subjects who were treated with a stable dose of oral hypoglycemic agents for more than 3 months before the random visit.
4. HbA1c is in the range of 7.5% -11.0 % by local laboratory analysis.
5. Body mass index (BMI) ≥18 kg/m2 and ≤40kg/m2.
6. Patients must give informed consent to this study before the trial, and voluntarily sign an informed consent form.
7. Patients who can communicate well with the investigator and can complete the study in accordance with the research regulations.

Exclusion Criteria

1. Diagnosed as type 1 diabetes or other types of diabetes.
2. Patients who have received insulin therapy for more than 7 days within 3 months before screening .
3. Patients who have received a thiazolidinedione (TZD) or GLP-1 receptor agonist within 3 months before screening.
4. 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.
5. 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.
6. Patients with hypoglycemia who have recurring severe events with conscious and/or physical changes within 3 months before screening and need help from others.
7. Those who have experienced acute metabolic complications (ketoacidosis, lactic acidosis, or hyperosmolar coma, etc.) within 3 months before screening.
8. Patients with obvious liver and kidney dysfunction.
9. Hemoglobin <100g/L.
10. When the virological test during the screening period shows that any of the following is met:

(1) HCV（hepatitis C virus） antibody is positive, and the HCV virus titer test value exceeds the upper limit of normal value; (2) HBsAg（Hepatitis B surface antigen） is positive and the HBV（hepatitis B virus） DNA test value exceeds the upper limit of normal; (3) HIV（human immunodeficiency virus） positive; (4) Active syphilis;

11. At the time of screening, there are thyroid diseases that have not been controlled with stable doses of drugs within 6 months, and the results of thyroid function tests during the screening period are abnormal and have clinical significance.

12. Uncontrolled or poorly treated high blood pressure.

13. Those with decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, cardiac surgery or blood vessel reconstruction (including coronary artery bypass grafting or percutaneous coronary intervention) occurred within 6 months before screening.

14. Those with proliferative retinopathy or macular degeneration (macular edema) that requires urgent treatment during screening.

15. Once diagnosed as malignant tumor (except for basal cell carcinoma or squamous cell skin cancer).

16. Patients with severe chronic gastrointestinal diseases (such as active peptic ulcer) and severe infections.

17. Those who are allergic to any ingredient in insulin deglu injection and Novota®.

18.Those who participated in any other clinical trials within 3 months before screening (excluding those who failed the screening or did not use study drugs for other reasons).

19. Pregnant women, lactating women, women of childbearing age who do not take appropriate contraceptive measures during the trial period (sterilization, intrauterine device, oral contraceptives or barrier contraception).

20. Those who are judged by the investigator to be unsuitable to participate in the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tresiba®	Tresiba®	Insulin degludec injection（Tresiba®）subcutaneous administration once daily for 26 weeks in combination with Oral antidiabetic drugs (OADs) used before.
Insulin degludec injection	Insulin degludec injection	Insulin degludec injection subcutaneous administration once daily for 26 weeks in combination with Oral antidiabetic drugs (OADs) used before.

Primary Outcome Measures

Name	Time	Method
Change value of glycosylated hemoglobin (HbA1c)	Baseline and 26 weeks	Change value of HbA1c from baseline following 26 weeks of therapy

Secondary Outcome Measures

Name	Time	Method
Percentage of patients achieving HbA1c ≤7% or HbA1c ≤6.5%	Baseline, week 26	Percentage of patients in each arm achieving HbA1c ≤7% or HbA1c ≤6.5% after 26 weeks of treatment.
Change value of fasting blood glucose	Baseline, week 14, week 26	Change value of fasting blood glucose following 14 and 26 weeks of therapy
Hypoglycemia	Baseline to week 26	Frequency of severe or symptomatic hypoglycemia during the 26-week treatment period
Immunogenicity	Baseline, week 14, week 26	The occurrence of immunogenicity during the 26-week treatment period by detecting Anti-Drug-Antibody(ADA).
Change value of HbA1c	Baseline, week 14	Change value of HbA1c from baseline following 14 weeks of therapy
Adverse events (AEs) and serious adverse events (SAEs)	Baseline to week 26	AEs and SAEs and their incidence during the 26-week treatment period, and then determine the correlation with the drug
Abnormal findings	Baseline to week 26	Abnormal findings during the 26-week treatment period，including abnormal findings of blood routine test，blood biochemical test as well as other abnormal laboratory findings.

Trial Locations

Locations (2)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China