Phase 4
Completed N=165
Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients
Source: ClinicalTrials.gov NCT01490918 ↗Enrolled (actual)
165
Serious AEs
1.8%
Results posted
Aug 2020
Primary outcomePrimary: The Change of Glycated Hemoglogin(HbA1c) From Baseline to 16 Weeks of Treatment — -0.09; -0.44; 0.84 % of HbA1c — p=0.0036
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change of Glycated Hemoglogin(HbA1c) From Baseline to 16 Weeks of Treatment |
-0.09; -0.44; 0.84 | 0.0036 sig |
| SECONDARY The Change of HbA1c From Baseline to 24 Weeks of Treatment |
-0.34; -0.47; 0.23 | <0.0001 sig |
| SECONDARY The Change of PPG2hr From Baseline to 24 Weeks of Treatment |
-1.73; -1.76; 0.06 | 0.0185 sig |
| SECONDARY Changes in Glucose During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2), |
28.85; -743.08 | 0.0356 sig |
| SECONDARY Changes in Insulin During Mixed Meal Tolerance Test Between 2 Group(Group 1 vs Group 2), |
647.65; 221.42 | 0.8258 |
| SECONDARY Change in Active GLP-1 at 0 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2) |
-8.55; -9.33 | 0.9217 |
| SECONDARY Change in Active GLP-1 at 120 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2) |
-32.92; -23.36 | 0.16 |
| SECONDARY Changes in Glucagon During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2), |
-79.22; -1411.79 | 0.004 sig |
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.
Data sourced from ClinicalTrials.gov (NCT01490918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.