Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study enrollment did not meet expectation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Non-interventional cohort study based on newly collected data under routine medical practice of a total of 500 Diabetes Mellitus, Type 2 patients
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linagliptin Initiators |
| ||
| Acarbose Initiators |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linagliptin | Drug | drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of T2DM patients with high medication adherence at Week 24 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The effectiveness of linagliptin and acarbose on glycemic control evaluated by reducing HbA1c during a 24 week follow-up in two groups | 24 weeks | |
| Proportion of T2DM patients achieving a therapeutic glycemic response defined as HbA1c < 7.0% or a lowering of HbA1c ≥ 0.5% |
Not provided
Inclusion Criteria:
These are patients who are on metformin and whose glucose levels are not adequately controlled.
Exclusion Criteria:
Not provided
Not provided
A total of 500 outpatients with T2DM from 16 sites distributed in different regions in mainland China.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.731 Hospital of China Aerospace Science & Industry Corp. | Beijing | 100074 | China | |||
| Affiliated Hospital of Chengdu University |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| D020909 | Acarbose |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
| Acarbose | Drug | drug |
|
| 24 weeks |
| To compare the composite endpoint (proportion of achieving HbA1c < 7.0% without gastrointestinal adverse events (GI AEs) and without an investigator defined hypoglycaemic event) | 24 weeks |
| Patient satisfaction by Diabetes Treatment Satisfaction Questionnaire (DTSQ) among linagliptin and acarbose initiators. The DTSQ would be completed at routine physician visits since initiation of the drug | 24 weeks |
| Chengdu |
| 610081 |
| China |
| ChongQing The Fourth Hospital | Chongqing | 400014 | China |
| Dongying People's Hospital | Dongying | 257000 | China |
| Huai'an first people's hospital | Huai'an | 223300 | China |
| Nanjing Drum Tower Hospital | Nanjing | 210008 | China |
| Zhongda Hospital Southeast University | Nanjing | 210009 | China |
| Shanghai TCM-Integrated Hospital | Shanghai | 200000 | China |
| Southern Medical University Shenzhen Hospital | Shenzhen | 518110 | China |
| Zhangjiagang First People Hospital | Suzhou | 215699 | China |
| D004700 | Endocrine System Diseases |
| D011799 | Quinazolines |
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |