Diabetes Mellitus, Type 2
Conditions
Brief summary
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics of patients with type 2 diabetes mellitus starting Trazenta® Tablets or any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug).
Sponsors
Eli Lilly and Company
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male and female patients with type 2 Diabetes Mellitus who have never been treated with Trazenta tablets / Linagliptin (monotherapy) before enrollment. (Trazenta group) * Patients with type 2 Diabetes Mellitus starting any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug (OAD)) except Trazenta tablets. (OAD group)
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Drug Reactions (ADRs) | From start of the treatment until the end of this PMS, i.e. up to week 156 | An adverse drug reactions (ADR) was defined as an adverse event (AE) if either the investigator or the sponsor (or both) assessed the causal relationship of Trazenta® Tablets either as Yes, Probably yes or Can't be denied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c at the Last Observation During the Observation Period. | Baseline and 156 week or last observation | Change from baseline in Haemoglobin A1c (HbA1c) at the last observation during the observation period is presented as mean change from baseline and standard deviation (SD). |
Countries
Japan
Participant flow
Recruitment details
In this post marketing surveillance (PMS) study 4876 patients were registered: 2513 patients (Pts.) in Trazenta® Tablets group & 2363 patients in other Oral Antidiabetic Drug (OAD) group (grp). 2414 out of 2513 patients were treated (trt) with Trazenta® Tablets. For other OAD group only baseline data & no observation period.
Pre-assignment details
Non-interventional,observational prospective study based on newly collected data under routine medical practice with 1 grp of Pts. treated with long-term daily use of Trazenta® Tablets for evaluation of baseline,safety& efficacy data & another grp of Pts. treated with any other oral antidiabetic monotherapy for collection of baseline data only.
Participants by arm
| Arm | Count |
|---|---|
| Trazenta® Tablets Patients with type 2 diabetes mellitus were administered orally with 5 milligram (mg) of Trazenta® tablets for 156 weeks or until discontinuation. | 2,233 |
| Other OAD Patients with type 2 diabetes mellitus who were treated with any other oral antidiabetic monotherapy except Trazenta® tablets | 2,128 |
| Total | 4,361 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 127 | 0 |
| Overall Study | CRF not collected | 98 | 82 |
| Overall Study | Improvement | 105 | 0 |
| Overall Study | Lack of Efficacy | 143 | 0 |
| Overall Study | Lost to Follow-up | 435 | 0 |
| Overall Study | Not treated | 1 | 7 |
| Overall Study | Other than listed | 64 | 146 |
| Overall Study | Patients had no visit after entry | 70 | 0 |
Baseline characteristics
| Characteristic | Trazenta® Tablets | Other OAD | Total |
|---|---|---|---|
| Age, Continuous | 66.7 Years STANDARD_DEVIATION 12.5 | 65.3 Years STANDARD_DEVIATION 12.6 | 66.0 Years STANDARD_DEVIATION 12.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 929 Participants | 910 Participants | 1839 Participants |
| Sex: Female, Male Male | 1304 Participants | 1218 Participants | 2522 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 34 / 2,235 |
| other Total, other adverse events | 0 / 2,235 |
| serious Total, serious adverse events | 116 / 2,235 |
Outcome results
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs)
An adverse drug reactions (ADR) was defined as an adverse event (AE) if either the investigator or the sponsor (or both) assessed the causal relationship of Trazenta® Tablets either as Yes, Probably yes or Can't be denied.
Time frame: From start of the treatment until the end of this PMS, i.e. up to week 156
Population: Safety Set (SS): SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trazenta® Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs) | 10.74 Percentage of Participants |
Secondary
Change From Baseline in HbA1c at the Last Observation During the Observation Period.
Change from baseline in Haemoglobin A1c (HbA1c) at the last observation during the observation period is presented as mean change from baseline and standard deviation (SD).
Time frame: Baseline and 156 week or last observation
Population: Efficacy Set: A subset of the safety set, which includes all patients in the safety set except those who had no available efficacy data and/or who did not suffer from type 2 diabetes mellitus from the safety set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trazenta® Tablets | Change From Baseline in HbA1c at the Last Observation During the Observation Period. | -0.67 percentage of HbA1c | Standard Deviation 1.27 |