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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT04955834
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Insulin degludec injection — DRUG
    long-acting insulin
  • Tresiba® — DRUG
    long-acting insulin

Study Details

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.

Key Dates

Start date
Jul 27, 2021
Status verified
Sep 2021
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
344 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Change value of glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline and 26 weeks ]

Central Contacts

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