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

Sponsor
Shanghai 6th People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02438397
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
22
Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2014
Anticipated Primary Completion Date :
Oct 1, 2016
Anticipated Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: metformin+premix insulin

metformin:500mg tid

Drug: premix insulin
Premix-insulin(human insulin or analog) treatment will continue
Other Names:
  • human insulin or analog

    • Drug: metformin
    500 mg tid by Merck
    Other Names:
  • glucophage

    		•
    Experimental: acarbose+premix insulin

    acarbose:100mg tid

    Drug: premix insulin
    Premix-insulin(human insulin or analog) treatment will continue
    Other Names:
  • human insulin or analog

    • Drug: Acarbose
    100mg tid by Bayer
    Other Names:
  • Glucobay

    		•

    Outcome Measures

    Primary Outcome Measures

    1. MAGE: mean amplitude of glycemic excursion/MODD: mean of daily differences [12 weeks after treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the 6th affliliated hospital of Shanghai Jiaotong university Shanghai Shanghai China 200233

    Sponsors and Collaborators

    • Shanghai 6th People's Hospital

    Investigators

    • Principal Investigator: Weiping Jia, doctor, the 6th affiliated hospital of Shanghai Jiaotong university

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Weiping Jia, Professor,chief of endocrinology department, Shanghai 6th People's Hospital
    ClinicalTrials.gov Identifier:
    NCT02438397
    Other Study ID Numbers:
    • BHC-17782
    First Posted:
    May 8, 2015
    Last Update Posted:
    May 8, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Insulin
    Insulin, Globin Zinc
    Metformin
    Acarbose

    Study Results

    No Results Posted as of May 8, 2015