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

NCT04955834 | Unknown Phase 3

• 1 other identifier: TQF2409-III-01
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change value of glycosylated hemoglobin (HbA1c)

  Change value of HbA1c from baseline following 26 weeks of therapy

  Baseline and 26 weeks

Secondary Outcomes (7)

• Percentage of patients achieving HbA1c ≤7% or HbA1c ≤6.5%

  Baseline, week 26

• Change value of HbA1c

  Baseline, week 14

• Change value of fasting blood glucose

  Baseline, week 14, week 26

• Adverse events (AEs) and serious adverse events (SAEs)

  Baseline to week 26

• Hypoglycemia

  Baseline to week 26

Study Arms (2)

Insulin degludec injection

EXPERIMENTAL

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

Drug: Insulin degludec injection

Tresiba®

ACTIVE COMPARATOR

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

Drug: Tresiba®

Interventions

Insulin degludec injection DRUG

long-acting insulin

Insulin degludec injection

Tresiba® DRUG

long-acting insulin

Tresiba®

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/m2.
• 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.

You may not qualify if:

• 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:
• (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;
• \. 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.
• \. Uncontrolled or poorly treated high blood pressure.
• \. 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.
• \. Those with proliferative retinopathy or macular degeneration (macular edema) that requires urgent treatment during screening.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Zhiguang Zhou, Doctor

CONTACT

0731-85294018; zhouzg@hotmail.com

Qifu Li, Doctor

CONTACT

023-89012755; liqifu@yeah.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 9, 2021
• Study Start: July 27, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

CN (2)