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Study of Efficacy, Weight Control, and Safety in Newly-diagnosed Type 2 Diabetes With Different Antidiabetic Therapy

NCT03700801 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-03-18

No results posted yet for this study

Summary

Study Hypothesis：Compared with premixed insulin, triple oral combination therapy has similar hypoglycemic effect, better weight control and lower incidence of hypoglycemia.

Main objective: Comparing whether the hypoglycemic efficacy of the triple oral combination therapy is not inferior than that of the premixed insulin in the treatment of newly-diagnosed type 2 diabetes.

Secondary objective: Comparing the effects on body weight and the risk of inducing hypoglycemia between triple oral combination therapy and premixed insulin, and exploring the effects of these two therapies on weight control and safety.

Primary Study Endpoint: The absolute change in baseline of HAb1c after 12 weeks.

Secondary Study Endpoint: fasting blood glucose, 2-hour postprandial blood glucose, fasting C-peptide, 2-hour postprandial C-peptide, body weight, proportion of patients with hypoglycemia, etc.

Conditions

Interventions

DRUG

Triple combination therapy group

Triple oral hypoglycemic therapy based on metformin, dapagliflozin plus saxagliptin.

DRUG

Premixed insulin therapy group

Subcutaneous injection therapy with insulin aspart 30 in patients with T2DM

Sponsors & Collaborators

  • The Sixth Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Third Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Peking University Shenzhen Hospital

    collaborator OTHER

  • Dongguan Kanghua Hospital

    collaborator OTHER

  • First People's Hospital, Shunde China

    collaborator OTHER

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    collaborator OTHER

  • The Fifth Affiliated Hospital of Zunyi Medical College

    collaborator OTHER

  • Shenzhen Sixth People's Hospital

    collaborator OTHER

  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Jia Sun · Department of Endocrinology, Zhujiang Hospital, Southern Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-12-20
Completion
2019-12-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03700801 on ClinicalTrials.gov