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

• Status: Unknown status
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai 6th People's Hospital
• Treatments: Acarbose; Insulin; Insulin, Globin Zinc; Metformin

Criteria

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