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A randomized, double-blind, placebo-controlled study for FTZ in patients with type 2 diabetes

A randomized, double-blind, placebo-controlled study for FTZ in patients with type 2 diabetes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025934
Enrollment
Unknown
Registered
2019-09-15
Start date
2019-09-16
Completion date
Unknown
Last updated
2019-09-16

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

Conditions

T2DM

Interventions

Placebo group:FTZ Simulator 4 capsules (2.52g) each time, 3 times a day

Sponsors

The First Affiliated Hospital of Guangdong Pharmaceutical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years, gender is not limited; 2. Comply with the diagnosis of type 2 diabetes, FBG<9.0mmol/L, 2h-PBG<16.6mmol/L. 3. Agree to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. In the past 1 month, there are diabetic ketosis, non-ketotic hyperosmolar diabetes coma, and severe infection. 2. Chronic gastrointestinal disease or chronic malnutrition, patients with anemia or abnormal hemoglobin disease. 3. Transaminase AST or ALT is greater than 2 times the upper limit of normal, serum creatinine or blood urea nitrogen is greater than the upper limit of normal. 4. Those who are allergic to FTZ or its components or intolerant. 5. Have a mental illness. 6. Women who are pregnant or breastfeeding and women who plan to have a pregnancy. 7. Took hypoglycemic drugs in the past January; 8. Patients who have participated in other drug clinical trials or are participating in other clinical trials within 3 months prior to the trial.

Design outcomes

Primary

MeasureTime frame
At the 12th week (or last time), assess the glycosylated albumin change or compliance rate.;

Secondary

MeasureTime frame
At 12th Week (or last) assess the fasting blood glucose, 2 hours postprandial blood glucose change or compliance rate.;the scores of TCM symptom;the scores of single TCM symptom;

Countries

China

Contacts

Public ContactGuo Jiao

The First Affiliated Hospital of Guangdong Pharmaceutical University

guoj@gdpu.edu.cn+86 13826270928

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026