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

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
premix insulin
metformin
Acarbose
Sponsored by
Shanghai 6th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the 6th affliliated hospital of Shanghai Jiaotong universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

metformin+premix insulin

acarbose+premix insulin

Arm Description

metformin:500mg tid

acarbose:100mg tid

Outcomes

Primary Outcome Measures

MAGE: mean amplitude of glycemic excursion/MODD: mean of daily differences

Secondary Outcome Measures

Full Information

First Posted
May 5, 2015
Last Updated
May 5, 2015
Sponsor
Shanghai 6th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02438397
Brief Title
the Efficacy of Acarbose and Metformin on Blood Glucose Fluctuation When Combined With Premix Insulin
Acronym
CGMS
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 6th People's Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
metformin+premix insulin
Arm Type
Active Comparator
Arm Description
metformin:500mg tid
Arm Title
acarbose+premix insulin
Arm Type
Experimental
Arm Description
acarbose:100mg tid
Intervention Type
Drug
Intervention Name(s)
premix insulin
Other Intervention Name(s)
human insulin or analog
Intervention Description
Premix-insulin(human insulin or analog) treatment will continue
Intervention Type
Drug
Intervention Name(s)
metformin
Other Intervention Name(s)
glucophage
Intervention Description
500 mg tid by Merck
Intervention Type
Drug
Intervention Name(s)
Acarbose
Other Intervention Name(s)
Glucobay
Intervention Description
100mg tid by Bayer
Primary Outcome Measure Information:
Title
MAGE: mean amplitude of glycemic excursion/MODD: mean of daily differences
Time Frame
12 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jian Zhou, doctor
Phone
18930172033
Email
zhoujian8337@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiping Jia, doctor
Organizational Affiliation
the 6th affiliated hospital of Shanghai Jiaotong university
Official's Role
Principal Investigator
Facility Information:
Facility Name
the 6th affliliated hospital of Shanghai Jiaotong university
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
36273168
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.
Results Reference
derived

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

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