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

This study has been completed.
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: September 11, 2014
Last verified: September 2014

December 9, 2011
September 11, 2014
April 2012
September 2014   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01490918 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type-II Diabetes Mellitus
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: 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.
    Intervention: Drug: Acarbose
  • Active Comparator: Sitagliptin, Metformin, Acarbose
    The group's drugs not include placebo. (Metformin, Sitagliptin, Acarbose)
    Intervention: Drug: Acarbose
  • Placebo Comparator: Metformin placebo, Sitagliptin, Acarbose
    The Metformin placebo should be changed into real Metformin from the 16th week.
    Intervention: Drug: Acarbose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01490918
ACADEMIC
Yes
Kun-Ho Yoon, The Catholic University of Korea
The Catholic University of Korea
Bayer
Principal Investigator: Kun-HO Yoon, professor Seoul St. Mary's Hospital
The Catholic University of Korea
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP