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Effects of proline plus griseofulvin on blood glucose and blood pressure in elderly Chinese patients with type 2 diabetes mellitus combined with hypertension

Effects of proline plus griseofulvin on blood glucose and blood pressure in elderly Chinese patients with type 2 diabetes mellitus combined with hypertension

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106345
Enrollment
Unknown
Registered
2025-07-22
Start date
2025-07-25
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Type 2 diabetes

Interventions

Intervention group:Proline gagliflozin tablets were given on the basis of conventional diabetes and hypertension treatment, taking 25 mg/dose once a day. Treatment was continuous for 8 weeks.

Sponsors

Luoyang Oriental People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosed with type 2 diabetes according to the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2024 Edition)", and diagnosed with hypertension according to the "Chinese Guidelines for the Prevention and Treatment of Hypertension (2024 Revised Edition)"; 2. Glycated hemoglobin (HbA1c) <=11% or fasting blood glucose <=13.3 mmol/L; 3. Aged between 60 and 80 years old, regardless of gender; 4. Previously not treated with sodium-glucose cotransporter 2 inhibitors (SGLT2i), or discontinued SGLT2i for more than 7 days; 5. Patient's blood pressure is well controlled; 6. The original antidiabetic and antihypertensive regimen and medications have been used for more than 1 month prior to entering the study, and the determined treatment drugs and regimens will remain unchanged during the study period.

Exclusion criteria

Exclusion criteria: 1. Cardiac insufficiency, hepatic or renal insufficiency; 2. Urinary tract or genital tract infection; 3. Malignancy and chronic infection, psychiatric disorders, blood or immune system diseases, especially those requiring hormone therapy; 4. Severe diabetic complications/comorbidities, such as stroke, acute coronary syndrome, etc.; 5. Severe cardiovascular disease, surgical history; 6. Patients with isolated systolic hypertension, secondary hypertension, or a history of blood pressure controlled below 90/60 mmHg; 7. Use of glucagon-like peptide-1 receptor agonists or dipeptidyl peptidase 4 inhibitors; 8. History of hypersensitivity to drugs used in the study such as dapagliflozin propanediol or its excipients, or contraindications to the study drugs; 9. Subjects who, in the investigator's judgment, are unlikely to comply with the protocol, or have other severe physical or psychological conditions that may affect efficacy and safety.

Design outcomes

Primary

MeasureTime frame
Achievement of clinical control of glycated hemoglobin at 8 weeks of treatment;

Secondary

MeasureTime frame
Fasting blood glucose after 8 weeks of treatment;Blood pressure control rate after 8 weeks of treatment;

Countries

China

Contacts

Public ContactLi Suxia

Luoyang Oriental People's Hospital

dongfanglisuxia@126.com+86 135 2379 6280

Outcome results

None listed

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