Diabetes Mellitus, Type 2
Conditions
Brief summary
Non-interventional cohort study based on newly collected data under routine medical practice of a total of 500 Diabetes Mellitus, Type 2 patients
Interventions
DRUGLinagliptin
drug
DRUGAcarbose
drug
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient should fully know and understand the content of consent form, and the patient is willing and able to sign an informed consent form * Chinese outpatients with confirmed T2DM * Patients of ≥ 18, \< 80 years old * Patients currently use metformin monotherapy ≥ 1500 mg/day or maximum tolerable dose and whose glucose levels are not adequately controlled * HbA1c ≥ 7% and \< 12% * New user\* linagliptin or acarbose as combination therapy with metformin ≥ 1500 mg/day or maximum tolerable dose \*New user defined as a T2DM patient initiating linagliptin or acarbose as an add-on therapy. These are patients who are on metformin and whose glucose levels are not adequately controlled.
Exclusion criteria
* Type 2 diabetes mellitus patients who previously used any DPP-4 inhibitor/ GLP-1 receptor agonist at index date or any AGI at index date, are not eligible to participate. Also excluded are patients who currently using any glucose-lowering agent as monotherapy other than metformin. * Patients with clinically significant acute major organ or systemic disease or other condition judged by the investigator that would create difficulty for the 24-week follow-up. * Patients who participated in a clinical trial within 2 months prior to study enrolment date. * Patients diagnosed with Type 1 diabetes mellitus, secondary diabetes or gestational diabetes. * Current treatment with systemic steroids at time of informed consent or within 6 weeks prior to informed consent. * Patients with known significant GI disease as judged by the study physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of T2DM patients with high medication adherence at Week 24 | 24 weeks |
Secondary
| Measure | 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% | 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 |
Countries
China
Outcome results
None listed