Type 2 Diabetes MellitusPhase 4NCT01490918
Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients
A Phase 4 study testing Acarbose in people with Type 2 Diabetes Mellitus, run by The Catholic University of Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Acarbose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Sep 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Acarbose, Placebo acarbose, placebo metformin
- Keywords
- Acarbose, ACADEMIC
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcarboseDrug
Also called triple combination
Acarbose 50mg b.i.d at first, at the 2nd week 50mg t.i.d and the 4th week, 100mg tid.
Placebo acarboseDrug
Also called dual combination (metformin+sitagliptin)
acarbose placebo
placebo metforminDrug
Also called dual combination (acarbose + sitagliptin)
metformin placebo
| Study group | Role | What they receive |
|---|---|---|
| Acarbose placebo, Metformin, Sitagliptin | Placebo comparator | The Acarbose placebo should be changed into real Acarbose from the 16th week. Receives: Drug: Placebo acarbose |
| Sitagliptin, Metformin, Acarbose | Experimental | Metformin, Sitagliptin, Acarbose group Receives: Drug: Acarbose |
| Metformin placebo, Sitagliptin, Acarbose | Other | The Metformin placebo should be changed into real Metformin from the 16th week. Receives: Drug: placebo metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 16 weeks
Secondary outcomes (7)
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
Measured: baseline, 24 weeks
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
Measured: baseline, 24 weeks
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)
Measured: Visit 2(baseline) and Visit 5(16W)
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)
Measured: Visit 2(baseline) and Visit 5(16W)
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)
Measured: baseline, 16 week
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)
Measured: baseline, 16 week
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)
Measured: Visit 2(baseline) and Visit 5(16W)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startApr 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Kun-Ho Yoon, The Catholic University of Korea
- Investigators
- Kun-HO Yoon, professor, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490918
- Sponsor's protocol ID
- ACADEMIC
- Status last verified
- Jul 2020
- First submitted
- 9 Dec 2011
- Last updated
- 17 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01490918
- Acronym / sponsor ID
- ACADEMIC
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Acarbose, ACADEMIC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Apr 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Dec 2011 (estimated)
- Results
- Posted 17 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acarbose placebo, Metformin, Sitagliptin | Placebo comparator | Drug: Placebo acarboseThe Acarbose placebo should be changed into real Acarbose from the 16th week. |
| Sitagliptin, Metformin, Acarbose | Experimental | Drug: AcarboseMetformin, Sitagliptin, Acarbose group |
| Metformin placebo, Sitagliptin, Acarbose | Other | Drug: placebo metforminThe Metformin placebo should be changed into real Metformin from the 16th week. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcarboseAlso: triple combinationAcarbose 50mg b.i.d at first, at the 2nd week 50mg t.i.d and the 4th week, 100mg tid. | Drug | Sitagliptin, Metformin, Acarbose |
| Placebo acarboseAlso: dual combination (metformin+sitagliptin)acarbose placebo | Drug | Acarbose placebo, Metformin, Sitagliptin |
| placebo metforminAlso: dual combination (acarbose + sitagliptin)metformin placebo | Drug | Metformin placebo, Sitagliptin, Acarbose |
Primary outcome
The Change of Glycated Hemoglogin(HbA1c) From Baseline to 16 Weeks of Treatment
Time frame: baseline, 16 weeks
The change of glycated hemoglogin(HbA1c) from baseline to 16 weeks of treatment between Placebo + Metformin+Sitagliptin and Metformin + Sitagliptin + Acarbose group
7 secondary outcomes
The Change of HbA1c From Baseline to 24 Weeks of Treatment
Time frame: baseline, 24 weeks
The Change of PPG2hr From Baseline to 24 Weeks of Treatment
Time frame: baseline, 24 weeks
Changes in Glucose During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),
Time frame: Visit 2(baseline) and Visit 5(16W)
Changes in Insulin During Mixed Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),
Time frame: Visit 2(baseline) and Visit 5(16W)
Change in Active GLP-1 at 0 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2)
Time frame: baseline, 16 week
Change in Active GLP-1 at 120 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2)
Time frame: baseline, 16 week
Changes in Glucagon During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),
Time frame: Visit 2(baseline) and Visit 5(16W)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kun-HO Yoon, professor principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acarbose in people with Type 2 Diabetes Mellitus, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change of Glycated Hemoglogin(HbA1c) From Baseline to 16 Weeks of Treatment (time frame: baseline, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.