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Efficacy and safety evaluation of Acarbose chewable tablets treated with diabetes mellitus patients with poor insulin treatment

Efficacy and safety evaluation of Acarbose chewable tablets treated with diabetes mellitus patients with poor insulin treatment

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031284
Enrollment
Unknown
Registered
2020-03-26
Start date
2019-04-01
Completion date
Unknown
Last updated
2020-03-30

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

Conditions

type 2 diabetes

Interventions

Experimental Group:Insulin / metformin + acarbose chewable tablets
Control group:Insulin / metformin

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetic patients, aged 18-80 years, 19 =20 IU/d and =1500 mg/day or reaching the maximum tolerable dose of individuals) for 2 weeks; use of other hypoglycemic drugs, can be included in the group after half a year of washout period; HbA1c 3.7 to 11%; 4. Volunteer to participate in the clinical study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to acarbose and / or non active ingredients, biguanides or have severe allergic diseases; 2. Patients who had abdominal operation within two months; 3. Chronic gastrointestinal dysfunction patients with obvious digestive and absorption disorders; 4. Patients with diseases that may worsen due to flatulence (such as roemheld syndrome, severe hernia, intestinal obstruction and intestinal ulcer); 5. Serious impairment of heart, liver and kidney function (heart function level 3-4, ALT and / or ast more than 2.5 times of the upper limit of normal, creatinine clearance rate < 25ml / min); 6. Severe cardiovascular and cerebrovascular diseases in the past six months; 7. Patients with severe diabetes who need to be combined with other hypoglycemic drugs (random blood glucose is greater than 18 mmol/L); 8. Patients with malignant tumor and hematopathy; 9. Patients with chronic infectious diseases, collagen system diseases and other diseases that affect the results of the study; 10. Pregnant and lactating women, women of childbearing age do not agree to take contraceptive measures during the experiment; 11. Have mental disorders, cognitive disorders, etc. can not cooperate well; 12. Those who have participated in clinical trials of other drugs within three months; 13. Other conditions that the researchers think are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
HbA1C;Blood glucose fluctuation;

Secondary

MeasureTime frame
FPG, PPG;Blood lipid profile;Daily dose of insulin;Changes in weight and waistline;Incidence of hypoglycemia;Incidence of adverse reactions in digestive tract;

Countries

China

Contacts

Public ContactGuijun Qin

the First Affiliated Hospital of Zhengzhou University

13598860123/hyqingj@zzu.edu.cn+86 13598860123

Outcome results

None listed

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