Phase 3
Completed N=574
Comprehensive Add on Study in Japan
Source: ClinicalTrials.gov NCT01204294 ↗Enrolled (actual)
574
Serious AEs
6.5%
Results posted
Jan 2013
Primary outcomePrimary: Incidence of Adverse Events (AEs) — 69; 55; 62; 114 Patients
Summary
The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events (AEs) |
69; 55; 62; 114; 71; 44 | — |
| SECONDARY Glycosylated Haemoglobin A1c (HbA1c) |
7.98; 7.92; 7.86; 8.12; 7.87; 8.01 | — |
Eligibility Criteria
Inclusion criteria
- Diagnosis of type 2 diabetes mellitus
- Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug
Exclusion criteria
- Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism
- Impaired hepatic function
- Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate <30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate <60 ml/min (moderate renal impairment) at Visit 1
- Treatment with anti-obesity drugs
Data sourced from ClinicalTrials.gov (NCT01204294). 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.