NCT02438397

the Efficacy of Acarbose and Metformin on Blood Glucose Fluctuation When Combined With Premix Insulin

Explore the Efficacy of Acarbose and Metformin on Blood Glucose Fluctuation When Combined With Premix Insulin in Chinese Type 2 Diabetes by CGMS

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shanghai 6th People's Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

the study objective: to explore the efficacy of acarbose and metformin on glucose fluctuations as add on therapy in type 2 diabetes patients inadequately controlled with premix insulin.

Detailed description

Study Design:Prospective, parallel group, active-control, randomized, open-label. Study Organization:Single-center in China. Endocrinology and metabolism department of 6th affiliated hospital of Shanghai Jiaotong university Study Population: Type 2 diabetes inadequately controlled by premix-insulin therapy,40 patients per arm(acarbose add on/ metformin add on) both acarbose and metformin are widely used with premix-insulin in clinical practice, for the better glucose control and lower hypoglycemia incident. Acarbose delay the absorption of digested carbohydrates from the small intestine and thus lower both postprandial glucose and insulin levels which sequently improve glucose fluctuation Metformin improve the insulin resistance reduce the gluconeogenesis, glucose output and thus lower the fasting glucose

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	premix insulin	Premix-insulin(human insulin or analog) treatment will continue
DRUG	metformin	500 mg tid by Merck
DRUG	Acarbose	100mg tid by Bayer

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-05-08
• Last updated: 2015-05-08

Locations

1 site across 1 country: China