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

Type 2 Diabetes Clinical Trial

— CGMS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02438397
• Other study ID #: BHC-17782
• Status: Recruiting
• Phase: Phase 4
• First received: May 5, 2015
• Last updated: May 5, 2015
• Start date: December 2014
• Est. completion date: October 2016

Study information

• Verified date: May 2015
• Source: Shanghai 6th People's Hospital
• Contact: jian Zhou, doctor
• Phone: 18930172033
• Email: zhoujian8337[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosed T2DM patients (WHO, 1999).

• Premix Insulin therapy for more than 3 months, the daily dosage of insulin >20IU and <1IU/kg

• 30 =Age = 70 years old, male or female

• 7.0 = HbA1c =10.0%

• 18.5= BMI = 35 kg/m2

• Written Informed consent

Exclusion Criteria:

• Subject with type 1 diabetes or gestational diabetes mellitus and other specific types DM

• Those who can not tolerate AGI or who is suffering GI disease

• Metformin contradiction

• Concomitant 2 oral anti-diabetes medicine, or 1 OAD with maximum dose

• Subject with repeated severe hypoglycemia and/or unawareness of hypoglycemia

• Known or suspected allergy to trial product(s) or related products

• Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods throughout the trial

• Impaired liver function,

• Any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, cancer, TB, acute infection

• Uncontrolled hypertension

• Concomitant treatment which influences blood glucose

• Impaired renal function

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• premix insulin
Premix-insulin(human insulin or analog) treatment will continue
• metformin
500 mg tid by Merck
• Acarbose
100mg tid by Bayer

Locations

Country	Name	City	State
China	the 6th affliliated hospital of Shanghai Jiaotong university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MAGE: mean amplitude of glycemic excursion/MODD: mean of daily differences		12 weeks after treatment	No