Diabetes Mellitus, Type 2
Conditions
Brief summary
This is a prospective, non-interventional, open label, multi center, post marketing surveillance study designed to assess the safety, tolerability and efficacy of Linagliptin among Filipino patients with type 2 Diabetes Mellitus (DM) within the study duration of 24 weeks.
Interventions
DRUGLinagliptin
tablet
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Filipino of Asian race 2. Patient using Linagliptin within label or locally approved indication. The prescription of Linagliptin to the patient must be in the course of normal clinical practice and independent of the decision to include the patient in the study. 3. Male or female patients more than 18 years old 4. Body mass index less than or equal to 40 5. Diagnosed with type 2 DM 6. Uncontrolled type 2 DM with fasting blood sugar of more than 126 mg/dl and/or HbA1c more than 7%.
Exclusion criteria
1. Diagnosed with type 1 DM 2. Patients with acute illness requiring hospitalization in the past one month 3. Patients participating in a different study that includes an investigational drug 4. Patients with known hypersensitivity reaction to Linagliptin or any of tis components 5. Pregnant women and those women who have intentions of getting pregnant within the study duration 6. Nursing women 7. Patients with concomitant conditions that contraindicates Linagliptin use as described in its product information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Events and Serious Adverse Events | Week 24 | Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 24 of HbA1c | Baseline and 24 weeks | Change from baseline to week 24 of glycosylated hemoglobin (HbA1c) |
| Change From Baseline to Week 24 of Fasting Blood Sugar | Baseline and 24 weeks | Change from baseline to week 24 of fasting blood sugar |
Countries
Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Linagliptin Linagliptin 5 mg was administered orally once a day for 24 weeks | 660 |
| Total | 660 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | Other reason not defined above | 2 |
| Overall Study | Protocol Violation | 6 |
Baseline characteristics
| Characteristic | Linagliptin |
|---|---|
| Age, Continuous | 57.67 years STANDARD_DEVIATION 13.3 |
| Gender Female | 360 participants |
| Gender Male | 296 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 660 |
| serious Total, serious adverse events | 0 / 660 |
Outcome results
Primary
Frequency of Adverse Events and Serious Adverse Events
Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events.
Time frame: Week 24
Population: Safety analysis set which consisted of all patients who have taken at least one dose of linagliptin and participated in the follow-up visit, thus, having a baseline and end-point evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Linagliptin | Frequency of Adverse Events and Serious Adverse Events | Adverse Events | 0.8 percentage of participants |
| Linagliptin | Frequency of Adverse Events and Serious Adverse Events | Serious Adverse Events | 0.0 percentage of participants |
Secondary
Change From Baseline to Week 24 of Fasting Blood Sugar
Change from baseline to week 24 of fasting blood sugar
Time frame: Baseline and 24 weeks
Population: Effectiveness analysis set which included patients with complete baseline and follow up secondary outcomes. For this outcome measure this include patients with baseline and end-point data for fasting blood sugar.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Linagliptin | Change From Baseline to Week 24 of Fasting Blood Sugar | -65.0 mg/dl | Standard Deviation 66.5 |
Secondary
Change From Baseline to Week 24 of HbA1c
Change from baseline to week 24 of glycosylated hemoglobin (HbA1c)
Time frame: Baseline and 24 weeks
Population: Effectiveness analysis set which included patients with complete baseline and follow up secondary outcomes. For this outcome measure this include patients with baseline and end-point data for HbA1c.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Linagliptin | Change From Baseline to Week 24 of HbA1c | -1.7 percentage of HbA1c | Standard Deviation 1.5 |