Trial Outcomes & Findings for A Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus (NCT NCT01707147)
NCT ID: NCT01707147
Last Updated: 2019-01-11
Results Overview
Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta.
Recruitment status
COMPLETED
Target enrollment
3219 participants
Primary outcome timeframe
Up to 26 weeks (long-term surveillance)
Results posted on
2019-01-11
Participant Flow
A regulatory requirement prospective, non-interventional, open-label, multi-centre national study to monitor the safety and effectiveness of Trajenta (Linagliptin, 5 milligram (mg), once daily) in Korean patients with type 2 diabetes mellitus
All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria was violated.
Participant milestones
| Measure |
Trajenta (Linagliptin) 5 mg
Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.
|
|---|---|
|
Overall Study
STARTED
|
3219
|
|
Overall Study
COMPLETED
|
3119
|
|
Overall Study
NOT COMPLETED
|
100
|
Reasons for withdrawal
| Measure |
Trajenta (Linagliptin) 5 mg
Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.
|
|---|---|
|
Overall Study
Administered Trajenta prior to contract
|
5
|
|
Overall Study
Patients who have not taken Trajenta
|
1
|
|
Overall Study
Follow-up failure
|
17
|
|
Overall Study
Violated inclusion/exclusion criteria
|
77
|
Baseline Characteristics
Number of patients in safety analysis set
Baseline characteristics by cohort
| Measure |
Trajenta (Linagliptin) 5 mg
n=3119 Participants
Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.
|
|---|---|
|
Age, Continuous
|
61.24 Years
STANDARD_DEVIATION 11.95 • n=3119 Participants • Number of patients in safety analysis set
|
|
Sex: Female, Male
Female
|
1450 Participants
n=3119 Participants • Number of patients in safety analysis set
|
|
Sex: Female, Male
Male
|
1669 Participants
n=3119 Participants • Number of patients in safety analysis set
|
PRIMARY outcome
Timeframe: Up to 26 weeks (long-term surveillance)Population: Safety analysis set: This analysis set included all patients who were administrated Trajenta at least once, except patients violating inclusion/exclusion criteria, dosage administration or lost to follow up.
Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta.
Outcome measures
| Measure |
Trajenta (Linagliptin) 5 mg
n=3119 Participants
Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.
|
|---|---|
|
Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta
|
7.69 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Effectiveness analysis set: This set includes all patients of the safety analysis set for whom HbA1c values were measured at both baseline and after drug administration.
Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c).
Outcome measures
| Measure |
Trajenta (Linagliptin) 5 mg
n=2171 Participants
Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.
|
|---|---|
|
Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c)
Before drug administration
|
7.98 Percentage of HbA1c
Standard Deviation 1.51
|
|
Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c)
After drug administration
|
7.21 Percentage of HbA1c
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Effectiveness analysis set
Percentage of patients with occurrence of treat to target effectiveness response, that is HbA1c under treatment of \< 6.5% after 24 weeks of treatment.
Outcome measures
| Measure |
Trajenta (Linagliptin) 5 mg
n=2171 Participants
Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.
|
|---|---|
|
Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment
|
26.02 Percentage of patients
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Effectiveness analysis set
Percentage of patients with occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks of treatment).
Outcome measures
| Measure |
Trajenta (Linagliptin) 5 mg
n=2171 Participants
Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.
|
|---|---|
|
Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)
|
57.30 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Effectiveness analysis set: the patients with the data available for FPG
Change from baseline after 24 weeks in fasting plasma glucose (FPG).
Outcome measures
| Measure |
Trajenta (Linagliptin) 5 mg
n=2171 Participants
Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.
|
|---|---|
|
Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG)
Before drug administration
|
161.19 Milligrams per Deciliter
Standard Deviation 55.38
|
|
Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG)
After drug administration
|
143.51 Milligrams per Deciliter
Standard Deviation 46.76
|
Adverse Events
Trajenta (Linagliptin) 5 mg
Serious events: 49 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Trajenta (Linagliptin) 5 mg
n=3119 participants at risk
Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.06%
2/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Gastrointestinal disorders
Ileus
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Infections and infestations
Gastroenteritis
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Infections and infestations
Pneumonia
|
0.10%
3/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Infections and infestations
Herpes zoster
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Infections and infestations
Cystitis
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Infections and infestations
Pyelonephritis acute
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Infections and infestations
Bronchitis
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Infections and infestations
Vestibular neuronitis
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Infections and infestations
Sepsis
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.13%
4/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Nervous system disorders
Cerebral infarction
|
0.06%
2/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Nervous system disorders
Dysarthria
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
General disorders
Chest pain
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
General disorders
Pyrexia
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
General disorders
Face oedema
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
General disorders
Fatigue
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
General disorders
Death
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.13%
4/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Injury, poisoning and procedural complications
Pneumoconiosis
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.06%
2/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Cardiac disorders
Angina pectoris
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Cardiac disorders
Angina unstable
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Cardiac disorders
Cardiac arrest
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Eye disorders
Diabetic retinopathy
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Renal and urinary disorders
End stage renal disease
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Hepatobiliary disorders
Cholangitis
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Ear and labyrinth disorders
Vertigo
|
0.06%
2/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
|
Immune system disorders
Renal transplant failure
|
0.03%
1/3119 • From the entire surveillance period until re-examination period, up to 6 years.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER