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Educational management project for postprandial blood glucose in diabetes

Using continuous glucose monitoring to compare the effects of metformin combined with acarbose or sitagliptin treatment on glycemic fluctuation in patients with type 2 diabetes mellitus: a randomized controlled parallel clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039424
Enrollment
Unknown
Registered
2020-10-27
Start date
2020-11-01
Completion date
Unknown
Last updated
2021-02-01

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

Conditions

Type 2 diabetes

Interventions

Baseline metformin combined with DPP-4i group:metformin combined with acarbose group (metformin 500mg tid, acarbose 100mg tid) or metformin combined with sitagliptin group (metformin 500mg tid, sitagl
Baseline metformin combined with AGI group:metformin combined with acarbose group (metformin 500mg tid, acarbose 100mg tid) or metformin combined with sitagliptin group (metformin 500mg tid, sitaglipt

Sponsors

Department of Endocrinology and Metabolism, Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with type 2 diabetes (WHO, 1999 diagnosis criteria); 2. Patients now receiving metformin combined with acarbose or metformin combined with sitagliptin treatment for at least 1 month; 3. Aged 18-65 years, male or female; 4. Level of HbA1c from 6% to 9%; 5. 19 <= BMI <= 35 kg/m2; 6. Signing the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with repetitive onset of severe hypoglycemia or asymptomatic hypoglycemia; 2. Suspiciously or confirmed allergic to hypoglycemic agents used in this trial; 3. Women in pregnancy or in lactation period, or with intends of pregnancy during the trial period; 4. Patients with abnormal hepatic function, defined as ALT or AST exceeding 2.5 times of normal upper limit; 5. Patients with systematic diseases, including severe heart disease, tumor, tuberculosis, acute infectious disease and so on; 6. Patients with systematically endocrine diseases (hypothyroidism, hyperthyroidism, hypercortisolism); 7. Hypertension without ideal control, defined as SBP >= 180mmHg and/or DBP >= 100mmHg; 8. Diabetic ketoacidosis or hyperosmotic non-ketotic hyperglycemic coma; 9. Accompanying systematic diseases which may influence the change of blood glucose and body weight; 10. Patients with abnormal renal function, defined as Cr >= 1.5 mg/dl (male) ?Cr >= 1.4 mg/dl (female) 11. Patients with mental diseases or problem of drug abuse; 12. Patients with intends to conduct X-ray, CT and MRI examination during the 14-day trial period with FGM; 13. Patients currently participating in other drug clinical trials; 14. Patients evaluated as not suitable for this clinical trial by researchers.

Design outcomes

Primary

MeasureTime frame
Flash continuous glucose monitoring data;

Secondary

MeasureTime frame
Heart rate;blood pressure;Respiration rate;Height;Weight;BMI;blood routine;urine routine;urine pregnancy test;Hepatic function (ALT, AST);Renal function (CRE, calculated eGFR);Fasting blood glucose;HbA1c;Glycated albumin;Fasting insulin;Fasting C-peptide;Serum cytokine testing;12-lead electrocardiogram;

Countries

China

Contacts

Public ContactLinong Ji

Department of Endocrinology and Metabolism, Peking University People's Hospital

jiln@bjmu.edu.cn+86 10-88324108

Outcome results

None listed

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