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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: premix insulin
* Drug: metformin
* Drug: Acarbose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metformin+premix insulin<br>metformin:500mg tid | Drug: premix insulin<br>* Premix-insulin(human insulin or analog) treatment will continue<br>* Other names: human insulin or analog;Drug: metformin<br>* 500 mg tid by Merck<br>* Other names: glucophage;|
| Experimental: acarbose+premix insulin<br>acarbose:100mg tid | Drug: premix insulin<br>* Premix-insulin(human insulin or analog) treatment will continue<br>* Other names: human insulin or analog;Drug: Acarbose<br>* 100mg tid by Bayer<br>* Other names: Glucobay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAGE: mean amplitude of glycemic excursion/MODD: mean of daily differences |  | 12 weeks after treatment |