Trials / Completed
CompletedNCT02330406
Randomized Evaluation of Anagliptin Versus Sitagliptin On Low-density lipoproteiN Cholesterol in Diabetes Trial
Effect of Anagliptin and Sitagliptin on Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes and Cardiovascular Risk Factors: Randomized Controlled Trial
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 353 (actual)
- Sponsor
- Institute for Clinical Effectiveness, Japan · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether Anagliptin or Sitagliptin are effective in reducing the low-density lipoprotein cholesterol in patients with type 2 diabetes and cardiovascular risk factors on statin.
Detailed description
Diabetes is a significant cause of cardiovascular and cerebrovascular events. Especially, diabetic patients with cardiovascular risk factors were significantly higher risk for cardiovascular and cerebrovasculara event. Therefore, several medical management strategies including anti-diabetic medications and statins were considered for those patients. However, in spite of such treatment, still many patients have cardiovascular and cerebrovascular events. One of the hypothesis is the residual risk such as elevated low-density lipoprotein cholesterol (LDLC) even with statin therapy. Anagliptin, one of the dipeptidyl peptidase-4 (DPP4) inhibiors, was reported to reduce LDLC and may have pontential to decrease the cardiovascular and cerebrovascular risk for such patients on statins. We, thus, conduct a randomized controlled trial to compare Anagliptin or Sitagliptin in terms of change of LDLC for 52 weeks as well as glycemic control.
Conditions
- Dipeptidyl-Peptidase 4 Inhibitors
- LDL Cholesterol
- Glycosylated Hemoglobin
- Diabetes Mellitus
- Coronary Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anagliptin | Suiny 100 mg |
| DRUG | Sitagliptin | Januvia 50 mg Glactiv 50 mg |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2018-01-01
- Completion
- 2019-03-01
- First posted
- 2015-01-05
- Last updated
- 2019-08-28
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02330406. Inclusion in this directory is not an endorsement.