18 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.Secondary· Baseline and Week 24
This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.
Occurrence of treatment to target effectiveness response is an HbA1c under treatment of \< 6.5% after 24 weeks of treatment. This outcome measures percentage of patients achieving HbA1c \< 6.5% after 24 weeks.
Occurrence of relative effectiveness response. This outcome measures percentage of patients for which HbA1c has reduced by at least 0.5% after 24 weeks.
Group
Value
95% CI
TrajentaDuo® Tablet
46.78
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment.Secondary· 24 Weeks
This outcome has measured difference between Fasting Plasma Glucose (FPG) values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication.
Group
Value
95% CI
TrajentaDuo® Tablet
-17.12
± 52.60
Incidence Rate of Adverse Events (AE)Primary· Up to 26 weeks
The incidence rate is the number of new cases per population at risk in a given time period. The incidence rate was calculated in patients who take at least one Trajenta Duo
Group
Value
95% CI
TrajentaDuo® Tablet
11.99
Adverse events — posted to ClinicalTrials.gov
Time frame: From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
TrajentaDuo® Tablet
Serious: 15/709 (2%)
Deaths: 0/709
Serious adverse events (15 terms)
Reaction
System
TrajentaDuo® Tablet
Angina pectoris
Cardiac disorders
—
Acute myocardial infarction
Cardiac disorders
—
Angina unstable
Cardiac disorders
—
Diarrhoea
Gastrointestinal disorders
—
Pancreatitis
Gastrointestinal disorders
—
Stomatitis
Gastrointestinal disorders
—
Mediastinitis
Infections and infestations
—
Pneumonia
Infections and infestations
—
Rhinitis
Infections and infestations
—
Vitreous haemorrhage
Eye disorders
—
Pyrexia
General disorders
—
Ligament sprain
Injury, poisoning and procedural complications
—
Flank pain
Musculoskeletal and connective tissue disorders
—
Vocal cord polyp
Respiratory, thoracic and mediastinal disorders
—
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The primary objective of this study is to monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 21 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01903356.