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A double-blind, double dummy, randomized controlled trial for the efficacy and safety of miglitol 50 mg with acarbose 50 mg in the treatment of newly diagnosed overweight /obese type 2 diabetes patients.

A double-blind, double dummy, randomized controlled trial for the efficacy and safety of miglitol 50 mg with acarbose 50 mg in the treatment of newly diagnosed overweight/obese type 2 diabetes patients.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030267
Enrollment
Unknown
Registered
2020-02-27
Start date
2020-03-03
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

Type 2 diabetes

Interventions

Miglipidol treatment group:Miglitol 50mg tid, oral
Acarbose mimetic tablets, 50mg tid, oral
Acarbose treatment group:Acarbose 50mg tid, oral
Miglitol simulating tablets, 50mg tid, oral

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. Sign an informed consent form prior to any research procedure; 2. Diagnosis of type 2 diabetes (WHO 1999); 3. Those who have not received any hypoglycemic treatment or have had short-term hypoglycemic treatment (=18 and 7.5% and =24 and <35 kg/m2.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or breast-feeding, women who are pregnant and do not take appropriate methods of contraception to avoid pregnancy; 2. Have the following medical history: 1. Type 1 diabetes, pancreatic damage caused by diabetes or acromegaly or Cushing's syndrome with the following lesions; 2. Acute Complications of Diabetes: A history of ketoacidosis or hyperosmolar nonketotic coma has occurred in the past 6 months; 3. Uncontrolled high blood pressure, systolic blood pressure >=180 mmHg and / or diastolic blood pressure >=120mmHg; 4. Those with obvious blood system diseases, hemoglobin 194.5 mmol / L or K + > 5.5 mmol/L) within 4 weeks prior to screening or examination; 9. New York Heart Association (NYHA) grade III or IV congestive heart failure; 10. A significant history of cardiovascular disease in the past 3 months, defined as: myocardial infarction, coronary angioplasty or bypass surgery, valvular disease or repair, unstable angina, transient ischemic attack, or cerebrovascular accident; 11. History of gastrointestinal diseases: gastrointestinal anastomosis, intestinal resection, severe bowel, intestinal obstruction and intestinal ulcer; 12. Hereditary history of galactose intolerance, Lapp lactase deficiency and glucose-galactose malabsorption; 13. Have been diagnosed with a malignant tumor or have been treated for the past 5 years; 14. History of organ transplantation or acquired immunodeficiency syndrome (AIDS); 15. A history of alcohol abuse or drug abuse in the past 12 months; 16. Potentially unreliable patients and those patients who were judged to be unsuitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
HbA1c;

Secondary

MeasureTime frame
PPG;TG;Tch;VFA;INS;C-peptide;Glucagon;GLP-1;BMI;

Countries

China

Contacts

Public ContactLi Chen

Qilu Hospital of Shandong University

chenli3@medmail.com.cn+86 13791122906

Outcome results

None listed

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