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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-10-31

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.

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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

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metformin+premix insulin

metformin:500mg tid

Group Type ACTIVE_COMPARATOR

premix insulin

Intervention Type DRUG

Premix-insulin(human insulin or analog) treatment will continue

metformin

Intervention Type DRUG

500 mg tid by Merck

acarbose+premix insulin

acarbose:100mg tid

Group Type EXPERIMENTAL

premix insulin

Intervention Type DRUG

Premix-insulin(human insulin or analog) treatment will continue

Acarbose

Intervention Type DRUG

100mg tid by Bayer

Interventions

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premix insulin

Premix-insulin(human insulin or analog) treatment will continue

Intervention Type DRUG

metformin

500 mg tid by Merck

Intervention Type DRUG

Acarbose

100mg tid by Bayer

Intervention Type DRUG

Other Intervention Names

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human insulin or analog glucophage Glucobay

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No