Efficacy and Safety of Acarbose Chewable Tablets in Type 2 Diabetic Patients- randomized positive controlled double-blinded and double-dummy multicenter clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001534

Enrollment

Unknown

Registered

2011-07-28

Start date

2009-07-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

type 2 diabetes mellitus

Interventions

control group:acarbose 50mg (50mg each tablet) plus one dummy acarbose chewable tablet thrice daily

experimental group:acarbose chewable tablet 50mg (50mg each tablet) plus one dummy acarbose tablet thrice daily

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. type 2 diabetic patients; 2. patients aged 18-70 years; 3. patients with a BMI of 19–35 kg/m2; 4. patients whose blood glucose was insufficiently controlled by sulphanylureas and/or metformin and who were on a stable dose for 4 weeks before the start of the study with a HbA1c level of 7–10% and FPG>=7.0mmol/l, 2hPPG>=11.1mmol/l.

Exclusion criteria

Exclusion criteria: 1. have type 1 diabetes; 2. having taken insulin injection or entered in other clinical trials during the last 3 months; 3. presence of significant diseases or conditions, including severe acute or chronic diabetic complications, gastrointestinal diseases likely to be associated with abnormal gut mobility or altered absorption of nutrients; 4. medication causing a significant change in gastrointestinal mobility and/or absorption, such as cholestyramine; 5. treatment with preparations containing digestive enzymes; 6. administration of gastroprokinetic agent or intestinal adsorbents; 7. concomitant medication affecting glucose homeostasis, such as glucocorticoids; 8. hypertension (SBP>=160mmHg and/or DBP>=95mmHg); 9. WBC<4.0*10^9/L or anemia (HB<100g/L) or other hematological diseases; 10. have a currently impaired hepatic or renal function, transaminases elevated 1.5 times the upper limit of normal or above the upper limit of normal with HBeAg-positive, or serum creatinine elevated above the upper limit of normal or have any history of drug allergies or addiction and abuse of alcohol, or mental disorder; 11. pregnant or lactating women or patients with a desire of child bearing.

Design outcomes

Primary

Measure	Time frame
HbA1;	—

Secondary

Measure	Time frame
fasting and 2h blood glucose;	—

Countries

China

Contacts

Public ContactHaoming Tian

hmtian999@yahoo.com.cn+86 18980601303

Outcome results

None listed

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