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Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acarbose
Placebo acarbose
placebo metformin
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Acarbose, ACADEMIC

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects with type-II diabetes mellitus;
  2. Subjects aged between 20 and 80;
  3. Subjects whose HbA1c ratio is between 7.0% and 10.0%;
  4. Subjects who took Metformin and Sitagliptin for at least 12 weeks;
  5. Subjects who were given the explanation about this clinical study and signed the consent form.

Exclusion Criteria:

  1. Subjects who have taken drugs that are likely to affect blood glucose or who need to take such drugs, e.g., glucocorticoid;
  2. Subjects with severe renal diseases (men: Scr>1.5 / women: Scr>1.4);
  3. Subjects with severe liver diseases or whose AST and ALT are at least 2.5 times higher than the upper limits of normal (ULN);
  4. Subjects having the case history of lactic acidosis;
  5. Subjects who have the case history of myocardial infarction or unstable angina or who underwent the coronary artery bypass graft 6 months before the screening test or who have arrhythmia to be treated;
  6. Subjects with congestive heart failures to be treated;
  7. Subjects who fall into New York Heart Association (NYHA) class III or IV;
  8. Subjects having the case history of acute or chronic metabolic acidosis including ketoacidosis;
  9. Subjects who have been pregnant or who are in the period of lactation;
  10. Subjects diagnosed with malignant tumors within 5 years;
  11. Subjects who are hypersensitive to Metformin, Sitagliptin and Acarbose or their ingredients;
  12. Subjects with inflammatory bowel diseases or intestinal ulcers or enterostenosis (includes Subjects who are vulnerable to enterostenosis) or chronic enteric diseases related to digestion and absorption or whose symptoms are likely to worsen due to intestinal gas;
  13. Subjects who participated in other clinical studies as Subjects within 60 days before this study (or before taking the investigational drugs);
  14. Subjects judged unfit for this study by investigators.

Sites / Locations

  • MedicalExcellence

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Other

Arm Label

Acarbose placebo, Metformin, Sitagliptin

Sitagliptin, Metformin, Acarbose

Metformin placebo, Sitagliptin, Acarbose

Arm Description

The Acarbose placebo should be changed into real Acarbose from the 16th week.

Metformin, Sitagliptin, Acarbose group

The Metformin placebo should be changed into real Metformin from the 16th week.

Outcomes

Primary Outcome Measures

The Change of Glycated Hemoglogin(HbA1c) From Baseline to 16 Weeks of Treatment
The change of glycated hemoglogin(HbA1c) from baseline to 16 weeks of treatment between Placebo + Metformin+Sitagliptin and Metformin + Sitagliptin + Acarbose group

Secondary Outcome Measures

The Change of HbA1c From Baseline to 24 Weeks of Treatment
The change of glycated hemoglogin(HbA1c) from baseline to 24 weeks of treatment between 3 groups
The Change of PPG2hr From Baseline to 24 Weeks of Treatment
The change of PPG2hr (post prandia blood glucose 2hr from baseline to 24 weeks of treatment between 3 groups
Changes in Glucose During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),
Change of AUC(area under the curve) of glucose at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)
Changes in Insulin During Mixed Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),
Change of AUC(area under the curve) of insulin at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)
Change in Active GLP-1 at 0 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2)
Change of active GLP-1 at 0 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2)
Change in Active GLP-1 at 120 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2)
Change of active GLP-1 at 120 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2)
Changes in Glucagon During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),
Change of AUC(area under the curve) of glucagon at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)

Full Information

First Posted
December 9, 2011
Last Updated
July 31, 2020
Sponsor
The Catholic University of Korea
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01490918
Brief Title
Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients
Official Title
A Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Acarbose Added on Top of Metformin and Sitagliptin Combination Treatment in Type 2 Diabetes Mellitus Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary objective To evaluate the efficacy of Acarbose add-on therapy on glucose control in subjects with type 2 diabetes inadequately controlled with Metformin and Sitagliptin combination therapy. The effect of acarbose, an alpha glucosidase inhibitor as a third-line therapeutic medication in subject who are inadequately controlled with metformin and DPP4 inhibitor will be evaluated with multicenter, randomized, 24-week, double blinded, placebo-controlled study in Korea.
Detailed Description
Eligible subjects will be assigned among 3 groups randomly at a ration of 2:2:1 to the following groups and primary efficacy variable analyzed at week 16. group 1 : acarbose placebo + metformin + sitagliptin (with switching placebo to acarbose qt week 16) group 2 : acarbose + metformin + sitagliptin group 3 : acarbose + metformin placebo + sitagliptin (with switching placebo to metformin at week 16) After 16 week of treatment, all subjects in 3 groups will be treated as triple combination of acarbose + metformin + sitagliptin, and diabetes related variables be collected and analyzed. Primary Endpoint Changes in HbA1c (hemoglobin A1c) at 16 week from baseline between group1 vs grou2 Secondary Endpoints (1) Changes of HbA1c at 24 week between 3 groups (2) Changed of post-prandial blood glucose at 2 hour (ppg2h) at 16, 24 week for exploratory purpose, following data will be collected and analyzed continuous glucose monitoring system (CGMS) data among selected subjects in 3 groups mixed meal tolerance test in only available institution. (glucose, insulin, GLP-1, GIP, glucagon ) among selected subjects in group 1 and group 2 oxidative stress markers (8-OHdG, nitrotyrosin, CML) self monitoring of blood glucose

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
placebo medication
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acarbose placebo, Metformin, Sitagliptin
Arm Type
Placebo Comparator
Arm Description
The Acarbose placebo should be changed into real Acarbose from the 16th week.
Arm Title
Sitagliptin, Metformin, Acarbose
Arm Type
Experimental
Arm Description
Metformin, Sitagliptin, Acarbose group
Arm Title
Metformin placebo, Sitagliptin, Acarbose
Arm Type
Other
Arm Description
The Metformin placebo should be changed into real Metformin from the 16th week.
Intervention Type
Drug
Intervention Name(s)
Acarbose
Other Intervention Name(s)
triple combination
Intervention Description
Acarbose 50mg b.i.d at first, at the 2nd week 50mg t.i.d and the 4th week, 100mg tid.
Intervention Type
Drug
Intervention Name(s)
Placebo acarbose
Other Intervention Name(s)
dual combination (metformin+sitagliptin)
Intervention Description
acarbose placebo
Intervention Type
Drug
Intervention Name(s)
placebo metformin
Other Intervention Name(s)
dual combination (acarbose + sitagliptin)
Intervention Description
metformin placebo
Primary Outcome Measure Information:
Title
The Change of Glycated Hemoglogin(HbA1c) From Baseline to 16 Weeks of Treatment
Description
The change of glycated hemoglogin(HbA1c) from baseline to 16 weeks of treatment between Placebo + Metformin+Sitagliptin and Metformin + Sitagliptin + Acarbose group
Time Frame
baseline, 16 weeks
Secondary Outcome Measure Information:
Title
The Change of HbA1c From Baseline to 24 Weeks of Treatment
Description
The change of glycated hemoglogin(HbA1c) from baseline to 24 weeks of treatment between 3 groups
Time Frame
baseline, 24 weeks
Title
The Change of PPG2hr From Baseline to 24 Weeks of Treatment
Description
The change of PPG2hr (post prandia blood glucose 2hr from baseline to 24 weeks of treatment between 3 groups
Time Frame
baseline, 24 weeks
Title
Changes in Glucose During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),
Description
Change of AUC(area under the curve) of glucose at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)
Time Frame
Visit 2(baseline) and Visit 5(16W)
Title
Changes in Insulin During Mixed Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),
Description
Change of AUC(area under the curve) of insulin at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)
Time Frame
Visit 2(baseline) and Visit 5(16W)
Title
Change in Active GLP-1 at 0 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2)
Description
Change of active GLP-1 at 0 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2)
Time Frame
baseline, 16 week
Title
Change in Active GLP-1 at 120 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2)
Description
Change of active GLP-1 at 120 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2)
Time Frame
baseline, 16 week
Title
Changes in Glucagon During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),
Description
Change of AUC(area under the curve) of glucagon at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)
Time Frame
Visit 2(baseline) and Visit 5(16W)
Other Pre-specified Outcome Measures:
Title
Changes in Mean Glucose During CGMS Between 3 Group
Description
Change of mean glucose of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 3 groups
Time Frame
Visit 2(baseline) and Visit 5(16W)
Title
Changes in Variation of Glucose During CGMS Between 3 Group
Description
Change of standard deviation of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 3 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin vs placebo + acarbose + sitagliptin)
Time Frame
Visit 2(baseline) and Visit 5(16W)
Title
Changes in MAGE of Glucose During CGMS Between 2 Group(Group 1 vs Group 2),
Description
Change of mean amplitude of glycemic excursion of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)
Time Frame
Visit 2(baseline) and Visit 5(16W)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with type-II diabetes mellitus; Subjects aged between 20 and 80; Subjects whose HbA1c ratio is between 7.0% and 10.0%; Subjects who took Metformin and Sitagliptin for at least 12 weeks; Subjects who were given the explanation about this clinical study and signed the consent form. Exclusion Criteria: Subjects who have taken drugs that are likely to affect blood glucose or who need to take such drugs, e.g., glucocorticoid; Subjects with severe renal diseases (men: Scr>1.5 / women: Scr>1.4); Subjects with severe liver diseases or whose AST and ALT are at least 2.5 times higher than the upper limits of normal (ULN); Subjects having the case history of lactic acidosis; Subjects who have the case history of myocardial infarction or unstable angina or who underwent the coronary artery bypass graft 6 months before the screening test or who have arrhythmia to be treated; Subjects with congestive heart failures to be treated; Subjects who fall into New York Heart Association (NYHA) class III or IV; Subjects having the case history of acute or chronic metabolic acidosis including ketoacidosis; Subjects who have been pregnant or who are in the period of lactation; Subjects diagnosed with malignant tumors within 5 years; Subjects who are hypersensitive to Metformin, Sitagliptin and Acarbose or their ingredients; Subjects with inflammatory bowel diseases or intestinal ulcers or enterostenosis (includes Subjects who are vulnerable to enterostenosis) or chronic enteric diseases related to digestion and absorption or whose symptoms are likely to worsen due to intestinal gas; Subjects who participated in other clinical studies as Subjects within 60 days before this study (or before taking the investigational drugs); Subjects judged unfit for this study by investigators.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun-HO Yoon, professor
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedicalExcellence
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients

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