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Application of continuous glucose monitoring and 1,5-anhydro-glucitol to compare the effectiveness of insulin therapy with acarbose and metformin respectively of type 2 diabetes mellitus in Chinese population

Application of continuous glucose monitoring and 1,5-anhydro-glucitol to compare the effectiveness of insulin therapy with acarbose and metformin respectively of type 2 diabetes mellitus in Chinese population

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17011324
Enrollment
Unknown
Registered
2017-05-08
Start date
2017-06-01
Completion date
Unknown
Last updated
2017-05-22

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

Conditions

diabetes mellitus

Interventions

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: This study included type 2 diabetes patients with poorly controlled glucose treated with premixed insulin therapy. The inclusive criteria listed as follows 1. Type 2 diabetes; 2. treated with premixed insulin therapy = 3 months, and the current insulin dose = 20 IU/d, <1 IU/kg·d as well; 3. aged 30 - 70 years old; 4. BMI within the range of 18.535.0 kg/m2; 5. HbA1c 7.0% to 10.0%; 6. patients who have signed informed consent; 7. patients with the ability to conduct self-blood glucose monitoring.

Exclusion criteria

Exclusion criteria: exclusion criteria are as follows: 1. women with fertility, pregnancy, breastfeeding, willingness to pregnant during the study period, or not using appropriate contraceptive measures; 2. type 1 daibetes, GDM, or other special types of diabetes; 3. with gastrointestinal diseases, or can't tolerate a-glucosidase inhibors; 4. allergic to acarbose, metformin or related agents (known or suspected); 5. severe liver disease (ALT/AST > 1.5 times of the normal upper limit); 6. with unstable or severe angina, heart failure (NYHA III/IV); 7. with chronic wasting disease (malignant tumors, tuberculosis, etc.), blood disease, mental disease, autoimmune diseases, obvious digestion and absorption disorders, suffer from acute cerebrovascular disease in the latest 6 months; 8. drinking/smoking history; 9. can't control/untreated hypertension (defined as SBP = 180 mmHg and/or DBP = 100 mmHg); 10. treat with drugs which affect glucose metabolism, such as glucocorticoids, thyoxine; 11. renal dysfunction, defined as serum creatinine = 135 µmol/L (= 1.5 mg/dl, male) and = 110 µmol/L (= 1.3 mg/dl, female); 12. any metformin contraindications; 13. without the bility to conduct self-monitoring of blood glucose; 14. under the therapy of premixed insulin, combined with = 2 oral hypoglycemic agents, or with one oral hypoglycemic drug which reached the maximum therapeutic dose.

Design outcomes

Primary

MeasureTime frame
Amplitude of Plasma Glucose Excursions;

Secondary

MeasureTime frame
Diurnal fluctuation of blood glucose;glycated hemoglobin A1c;1,5-anhydroglucitol;fasting plasma glucose;2h postprandial glucose;body weight;insulin;

Countries

China

Contacts

Public ContactZHOU JIAN

Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

zhoujian8337@126.com+86 18930172033

Outcome results

None listed

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