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

May 5, 2015 updated by: Weiping Jia, Shanghai 6th People's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200233
        • Recruiting
        • the 6th affliliated hospital of Shanghai Jiaotong university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 6th People's Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Estimate)

May 8, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHC-17782

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on premix insulin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe