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Effects of FTZ in Type 2 Diabetes Mellitus and Coronary Heart Disease: a randomized controlled trial

the Efficacy and Safety of FTZ in Patients With Diabetes Mellitus Type 2 and Coronary Heart Disease: A Multicenter, Randomized, Double-Blind, Placebo Parallel-controlled Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022345
Enrollment
Unknown
Registered
2019-04-07
Start date
2019-04-08
Completion date
Unknown
Last updated
2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2 and Coronary Heart Disease

Interventions

Experimental Group:basic treatment + FTZ
Control group:basic treatment + FTZ placebo

Sponsors

the First Affiliated Hospital of Guangdong Pharmaceutical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes mellitus; 2. Coronary angiography or coronary CTA results suggest that at least one coronary stenosis or lumen stenosis is greater than or equal to 50%; 3. Aged 18 - 85 years; 4. Volunteer to participate in this clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with unstable condition, such as ACS, acute left heart failure and acute complications of diabetes; mellitus within three months; 2. Patients who plan for cardiac intervention or surgery in 1 year; 3. Pregnant or lactating women; 4. The life expectancy of patients with diabetic coronary heart disease associated with malignant tumor is less than 2 years; 5. Patients known or suspected of being sensitive to the study drug; 6. Severe renal impairment (eGFR=30%) and severe pulmonary disease (acute and chronic respiratory failure and moderate and severe pulmonary fibrosis, lung damage); ALT increased abnormally and CK increased abnormally (more than 2 times the upper limit of normal reference values); 7. Patients with mental disease and other patients who cannot cooperate with the drug use.

Design outcomes

Primary

MeasureTime frame
SF-36;Patient report outcome(PRO));the scores of TCM syndrom;MACE;—

Secondary

MeasureTime frame
TCM Constitutional Types;Carotid plaque;FMD%;BaPWV;ABI;visceral fat index (VFI);liver steatosis degree;Urinary albumin/creatinine;Lp—PLA2;HbAlc;C-Peptide;Insulin Assay;triglyceride(TC);HDL;LDL;blood uric acid;Blood glucose (fasting, 2 hours, 3 hours after a meal);Hemorheology;erythrocyte sedimentation rate (ESR);CRP;Homocysteine;—

Countries

China

Contacts

Public ContactGuo Jiao

Guangdong Pharmaceutical University

guoj@gdpu.edu.cn+86 13826270928

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026