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

This study is currently recruiting participants.
Verified February 2013 by The Catholic University of Korea
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Kun-Ho Yoon, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01490918
First received: December 9, 2011
Last updated: February 17, 2013
Last verified: February 2013
History of Changes
  Purpose

Primary objective To evaluate the efficacy of Acarbose added on top of Metformin and Sitagliptin that were combinedly administered to subjects with type-II diabetes, along with placebos.

Secondary objectives

  1. To compare a Metformin-Sitagliptin combination and a Sitagliptin-Acarbose combination in efficacy
  2. To evaluate the 6-month efficacy of Acarbose added on top of the Metformin-Sitagliptin combination

Condition Intervention Phase
Type-II Diabetes Mellitus
 Drug: Acarbose
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • To see if there's any change in HbA1c at Visit 5(16W) compared Visit 2(baseline) within each group and between the two group. [ Time Frame: Visit2(baseline) and Visit5(16week) ] [ Designated as safety issue: No ]
    Statistical analyses will progress through analysis of covariance (ANCOVA).


Secondary Outcome Measures:
  • To see if there's any Changes in CGMS, mixed meal tolerance test (active GLP-1, total GLP-1, GIP and insulin) and oxidative stress markers (8-OHdG, nitro tyrosine and CML) in Group-1 and Group-2 [ Time Frame: Visit 2(baseline) and Visit 5(16W), Visit 7(24W) ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: April 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Acarbose placebo, Metformin, Sitagliptin
The dose of Acarbose should be 50mg b.i.d, 50mg t.i.d and 100mg t.i.d at the 18th week, the 20th week and the 24th week respectively. The Acarbose placebo should be changed into real Acarbose from the 16th week.
 Drug: Acarbose
The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively
Other Name: Glucobay
Active Comparator: Sitagliptin, Metformin, Acarbose
The group's drugs not include placebo. (Metformin, Sitagliptin, Acarbose)
 Drug: Acarbose
The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively
Other Name: Glucobay
Placebo Comparator: Metformin placebo, Sitagliptin, Acarbose
The Metformin placebo should be changed into real Metformin from the 16th week.
 Drug: Acarbose
The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively
Other Name: Glucobay

Detailed Description:

1) Primary Endpoint With changes in HbA1c measured at the baseline and the 16th week, descriptive statistics (mean, standard deviation, median, minimum value, maximum value and 95% confidence interval) should be worked out. HbA1c, measured at the baseline, should be included in covariates, and a comparison should be made between Group-1 and Group-2 with the analysis of covariance (ANCOVA).

2) Secondary Endpoints

  1. Changes in CGMS, mixed meal tolerance test (active GLP-1, total GLP-1, GIP and insulin) and oxidative stress markers (8-OHdG, nitro tyrosine and CML) in Group-1 and Group-2:

    With the values measured at the baseline and the 16th week, mean, standard deviation, median, minimum value and maximum value should be calculated. To analyze the difference of two groups, perform an ANCOVA with baseline value as a covariate.

  2. Changes in HbA1c, FPG and PPG in Group-1 and Group-2:

    With the values measured at the baseline, the 16th week and the 24th week and at the 16th week and the 24th week, mean, standard deviation, median, minimum value and maximum value should be calculated. To analyze the difference of two groups, perform an ANCOVA with baseline value as a covariate.

  3. Changes in HbA1c, FPG and PPG in Group-1 and Group-3:

    With the values measured at the baseline, the 16th week and the 24th week and at the 16th week and the 24th week, mean, standard deviation, median, minimum value and maximum value should be calculated. To analyze the difference of two groups, perform an ANCOVA with baseline value as a covariate.

  4. Changes in SMBG in Group-1 and Group-2 and in Group-1 and Group-3:

    With the values measured at the 4th week, the 16th week and the 24th week and at the 16th week and the 24th week, mean, standard deviation, median, minimum value and maximum value should be calculated. To analyze the difference of two groups, perform an ANCOVA with baseline value(4wk) as a covariate.

  5. Changes in 1,5-AG in Group-1 and Group-2 and in Group-1 and Group-3:

With the values measured at the 16th week, mean, standard deviation, median, minimum value and maximum value should be calculated. To analyze the difference of two groups, perform an ANCOVA with baseline value as a covariate.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490918

Locations
Korea, Republic of
MedicalExcellence Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Jeong-Min Choi, CRM     82-2-2258-7896     jeongmin.choi@mediex.co.kr    
Contact: Hye-Ryun Jin, CRA     82-2-2258-7898     hr.jin@mediex.co.kr    
Principal Investigator: Kun-Ho Yoon, professor            
Sponsors and Collaborators
The Catholic University of Korea
Bayer
Investigators
Principal Investigator: Kun-HO Yoon, professor Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Kun-Ho Yoon, Professor, Medical doctor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01490918     History of Changes
Other Study ID Numbers: ACADEMIC
Study First Received: December 9, 2011
Last Updated: February 17, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
Type-II diabetes mellitus
Acarbose
ACADEMIC

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
Acarbose
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013