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

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ClinicalTrials.gov Identifier: NCT01490918
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : September 15, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Type-II Diabetes Mellitus Drug: Acarbose Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : April 2012
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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) ]
    Statistical analyses will progress through analysis of covariance (ANCOVA).


Secondary Outcome Measures :
  1. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490918


Locations
Korea, Republic of
MedicalExcellence
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
The Catholic University of Korea
Bayer
Investigators
Principal Investigator: Kun-HO Yoon, professor Seoul St. Mary's Hospital
More Information

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
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: September 15, 2014
Last Verified: September 2014

Keywords provided by Kun-Ho Yoon, 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
Metformin
Sitagliptin Phosphate
Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Glycoside Hydrolase Inhibitors