Clinical trial NCT02438397: the Efficacy of Acarbose and Metformin on Blood Glucose Fluctuation When Combined With Premix Insulin
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: MAGE: mean amplitude of glycemic excursion/MODD: mean of daily differences
timeFrame: 12 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: the 6th affliliated hospital of Shanghai Jiaotong university
state: Shanghai
Study officials:
affiliation: the 6th affiliated hospital of Shanghai Jiaotong university
name: Weiping Jia, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gao F, Li C, Wang Y, Lu J, Lu W, Zhou J, Yin J, Ma X. Growth differentiation factor 15 is not associated with glycemic control in patients with type 2 diabetes mellitus treated with metformin: a post-hoc analysis of AIM study. BMC Endocr Disord. 2022 Oct 22;22(1):256. doi: 10.1186/s12902-022-01176-3.