Trial Outcomes & Findings for A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in Korea (NCT NCT01903356)

NCT ID: NCT01903356

Last Updated: 2018-12-21

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

724 participants

Primary outcome timeframe

Up to 26 weeks

Results posted on

2018-12-21

Participant Flow

This is an observational study in patients with type 2 diabetes mellitus who had been administered with TrajentaDuo® Tablets. The Case Report Forms of 724 subjects investigated by 15 investigators at 14 hospitals were retrieved from November 15, 2012 up to September 13, 2017.

All patients were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be enrolled in the study if any one of the specific entry criteria were violated.

Participant milestones

Participant milestones
Measure	TrajentaDuo® Tablet Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet
Overall Study STARTED	724
Overall Study COMPLETED	709
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	TrajentaDuo® Tablet Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet
Overall Study Lost to Follow-up	7
Overall Study Violated inclusion/exclusion criteria	5
Overall Study Violated the dosage and administration	3

Baseline Characteristics

Safety Analysis Set: This analysis set included all subjects except subjects violating inclusion/exclusion criteria, dosage adminstration or were lost to follow up.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TrajentaDuo® Tablet n=709 Participants Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet
Age, Continuous	62.04 Years STANDARD_DEVIATION 11.56 • n=709 Participants • Safety Analysis Set: This analysis set included all subjects except subjects violating inclusion/exclusion criteria, dosage adminstration or were lost to follow up.
Sex: Female, Male Female	358 Participants n=709 Participants • Safety Analysis Set: This analysis set included all subjects except subjects violating inclusion/exclusion criteria, dosage adminstration or were lost to follow up.
Sex: Female, Male Male	351 Participants n=709 Participants • Safety Analysis Set: This analysis set included all subjects except subjects violating inclusion/exclusion criteria, dosage adminstration or were lost to follow up.
Hemoglobin A1c (HbA1c) at baseline	7.78 Percentage of HbA1c (%) STANDARD_DEVIATION 1.35 • n=481 Participants • Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks.

PRIMARY outcome

Timeframe: Up to 26 weeks

Population: Safety Analysis Set: This analysis set included all subjects except subjects violating inclusion/exclusion criteria, dosage adminstration or were lost to follow up.

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

Outcome measures

Outcome measures
Measure	TrajentaDuo® Tablet n=709 Participants Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet
Incidence Rate of Adverse Events (AE)	11.99 Percentage of patients (%)

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks.

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.

Outcome measures

Outcome measures
Measure	TrajentaDuo® Tablet n=481 Participants Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet
Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.	-0.75 Percentage (%) of HbA1c Standard Deviation 1.48

SECONDARY outcome

Timeframe: 24 Weeks

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.

Outcome measures

Outcome measures
Measure	TrajentaDuo® Tablet n=481 Participants Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet
Target Effectiveness Response Rate	33.06 Percentage of Patients (%)

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TrajentaDuo® Tablet n=481 Participants Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet
Relative Effectiveness Response Rate	46.78 Percentage of patients (%)

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TrajentaDuo® Tablet n=481 Participants Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment.	-17.12 Milligram/deciLitre (mg/dL) Standard Deviation 52.60

Adverse Events

TrajentaDuo® Tablet

Serious events: 15 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TrajentaDuo® Tablet n=709 participants at risk Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet
Cardiac disorders Angina pectoris	0.28% 2/709 • From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.
Cardiac disorders Acute myocardial infarction	0.14% 1/709 • From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.
Cardiac disorders Angina unstable	0.14% 1/709 • From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.
Gastrointestinal disorders Diarrhoea	0.14% 1/709 • From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.
Gastrointestinal disorders Pancreatitis	0.14% 1/709 • From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.
Gastrointestinal disorders Stomatitis	0.14% 1/709 • From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.
Infections and infestations Mediastinitis	0.14% 1/709 • From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.
Infections and infestations Pneumonia	0.14% 1/709 • From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.
Infections and infestations Rhinitis	0.14% 1/709 • From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.
Eye disorders Vitreous haemorrhage	0.14% 1/709 • From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.
General disorders Pyrexia	0.14% 1/709 • From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.
Injury, poisoning and procedural complications Ligament sprain	0.14% 1/709 • From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.
Musculoskeletal and connective tissue disorders Flank pain	0.14% 1/709 • From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.14% 1/709 • From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.14% 1/709 • From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.

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