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

Phase 4

• Conditions: Type 2 Diabetes
• Interventions: Drug: premix insulin; Drug: Acarbose; Drug: metformin

• Registration Number: NCT02438397
• Lead Sponsor: Shanghai 6th People's Hospital

Brief 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

Study Timeline

• Study Start: 2014-12
• Status Verified: 2015-05
• Study First Submitted: 2015-05-05
• Study First Submitted QC: 2015-05-05
• Last Update Submitted: 2015-05-05
• Study First Posted: 2015-05-08
• Last Update Posted: 2015-05-08
• Primary Completion: 2016-10
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acarbose+premix insulin	Acarbose	acarbose:100mg tid
metformin+premix insulin	premix insulin	metformin:500mg tid
acarbose+premix insulin	premix insulin	acarbose:100mg tid
metformin+premix insulin	metformin	metformin:500mg tid

Primary Outcome Measures

Name	Time	Method
MAGE: mean amplitude of glycemic excursion/MODD: mean of daily differences	12 weeks after treatment

Trial Locations

Locations (1)

the 6th affliliated hospital of Shanghai Jiaotong university; 🇨🇳 Shanghai, Shanghai, China