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Efficacy and Safety of Chiglitazar Added to Glargine in Patients With Type 2 Diabetes

NCT06007014 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2023-09-13

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the Efficacy and Safety of Chiglitazar Added to Patients with type 2 diabetes who do not respond well to metformin combined with insulin glargine. The main question it aims to answer are:

• T2DM patients still cannot effectively control their blood sugar with the combination of insulin and metformin. The combination of follow-up treatment and hypoglycemic drugs is worth exploring, and it is necessary to explore and confirm the combination of effective and safe drugs for insulin resistance on the basis of the above treatment plans.

Participants will be asked to receive either Chiglitazar or placebo in addition to metformin and insulin glargine 18 weeks.

Researchers will compare placebo groups to see if the effective effect and safety indicators of Chiglitazar for reducing insulin dosage, lowering blood sugar, regulating blood lipids.

Conditions

  • Efficacy and Safety of Chiglitazar Sodium in the Treatment of T2DM Patients
  • Metformin Combined With Insulin Glargine in the Treatment of Type 2 Diabetes Patients Who Still Have Poor Hypoglycemic Effect
  • 128 Patients Were Randomly Assigned 1:1
  • Metformin and Insulin Glargine Combined With Chiglitazar Sodium Tablets 48mg/ Day Group
  • Metformin and Insulin Glargine Combined With Placebo Group
  • InvestigatorInitiate Trial
  • Changes in HbA1C From Baseline at 18 Weeks of Treatment

Interventions

DRUG

Chiglitazar sodium

tablets 48mg/ day administered for 18 weeks

DRUG

Chiglitazar placebo

tablets 48mg/ day administered for 18 weeks

Sponsors & Collaborators

  • Yanbing Li

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2025-10-30
Completion
2025-12-30

Countries

  • China

Study Locations

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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 NCT06007014 on ClinicalTrials.gov