Trial Outcomes & Findings for Empagliflozin Add on to Linagliptin Study in Japanese Patient With Type 2 Diabetes Mellitus (NCT NCT02453555)
NCT ID: NCT02453555
Last Updated: 2019-02-15
Results Overview
Change from baseline in Glycosylated haemoglobin A1c (HbA1c) at Week 24 was calculated as: HbA1c at Week 24 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
275 participants
Primary outcome timeframe
Baseline and 24 week
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
Empagliflozin 10 Milligram (mg)/Linagliptin 5 Milligram (mg)
Patients were administered a fixed dose combination (FDC) of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
Linagliptin 5 mg + Placebo 10 mg
Patients were administered a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
Empagliflozin 25 mg/Linagliptin 5 mg (Extension Period)
Patients with insufficient response based on Glycosylated haemoglobin A1c (HbA1c) after 24-week of double-blind treatment period were up-titrated to a FDC of 25 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of up-titration period (from Week 28 to Week 52).
|
Empagliflozin 10 mg/Linagliptin 5 mg (Extension Period)
Patients with sufficient response based on HbA1c after 24-week of double-blind treatment period were continued on a FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for subsequent 28 weeks of extension period.
|
Linagliptin 5 mg + Placebo 25 mg (Extension Period)
Patients with insufficient response based on HbA1c after 24-week of double-blind treatment period were up-titrated to receive a matching placebo of FDC of 25 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of up-titration period (from Week 28 to Week 52).
|
Linagliptin 5 mg + Placebo 10 mg (Extension Period)
Patients with sufficient response based on HbA1c after 24-week of double-blind treatment period were continued on a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for subsequent 28 weeks of extension period.
|
|---|---|---|---|---|---|---|
|
24-week Double-blind Treatment Period
STARTED
|
182
|
93
|
0
|
0
|
0
|
0
|
|
24-week Double-blind Treatment Period
COMPLETED
|
177
|
86
|
0
|
0
|
0
|
0
|
|
24-week Double-blind Treatment Period
NOT COMPLETED
|
5
|
7
|
0
|
0
|
0
|
0
|
|
Extension Period
STARTED
|
0
|
0
|
126
|
51
|
80
|
6
|
|
Extension Period
COMPLETED
|
0
|
0
|
123
|
49
|
79
|
5
|
|
Extension Period
NOT COMPLETED
|
0
|
0
|
3
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Empagliflozin 10 Milligram (mg)/Linagliptin 5 Milligram (mg)
Patients were administered a fixed dose combination (FDC) of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
Linagliptin 5 mg + Placebo 10 mg
Patients were administered a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
Empagliflozin 25 mg/Linagliptin 5 mg (Extension Period)
Patients with insufficient response based on Glycosylated haemoglobin A1c (HbA1c) after 24-week of double-blind treatment period were up-titrated to a FDC of 25 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of up-titration period (from Week 28 to Week 52).
|
Empagliflozin 10 mg/Linagliptin 5 mg (Extension Period)
Patients with sufficient response based on HbA1c after 24-week of double-blind treatment period were continued on a FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for subsequent 28 weeks of extension period.
|
Linagliptin 5 mg + Placebo 25 mg (Extension Period)
Patients with insufficient response based on HbA1c after 24-week of double-blind treatment period were up-titrated to receive a matching placebo of FDC of 25 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of up-titration period (from Week 28 to Week 52).
|
Linagliptin 5 mg + Placebo 10 mg (Extension Period)
Patients with sufficient response based on HbA1c after 24-week of double-blind treatment period were continued on a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for subsequent 28 weeks of extension period.
|
|---|---|---|---|---|---|---|
|
24-week Double-blind Treatment Period
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
0
|
|
24-week Double-blind Treatment Period
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
|
24-week Double-blind Treatment Period
Withdrawal by Subject
|
2
|
4
|
0
|
0
|
0
|
0
|
|
24-week Double-blind Treatment Period
Other than specified above
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Extension Period
Adverse Event
|
0
|
0
|
1
|
2
|
1
|
1
|
|
Extension Period
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Extension Period
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Empagliflozin Add on to Linagliptin Study in Japanese Patient With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Empagliflozin 10 mg/Linagliptin 5 mg
n=182 Participants
Patients were administered a fixed dose combination (FDC) of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
Linagliptin 5 mg + Placebo 10 mg
n=93 Participants
Patients were administered a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
Total
n=275 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 Years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
59.8 Years
STANDARD_DEVIATION 10.8 • n=107 Participants
|
59.9 Years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
214 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weekPopulation: The primary analysis was performed on the FAS (observed case \[OC\]) with treatment assignment as randomised.
Change from baseline in Glycosylated haemoglobin A1c (HbA1c) at Week 24 was calculated as: HbA1c at Week 24 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
Outcome measures
| Measure |
Empagliflozin 10 mg/Linagliptin 5 mg
n=182 Participants
Patients were administered a fixed dose combination (FDC) of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
Linagliptin 5 mg + Placebo 10 mg
n=93 Participants
Patients were administered a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
|---|---|---|
|
Change of Glycosylated Haemoglobin A1c (Glycosylated Haemoglobin A1c After 24 Weeks of Double-blind Treatment From Baseline)
|
-0.93 Percentage (%)
Standard Error 0.06
|
0.21 Percentage (%)
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 28 Week (pre up-titration) and 52 WeekPopulation: The full analysis set with up-titration-I (FASUT-I) consisted of all patients who were up-titrated and were treated with at least 1 dose of Empagliflozin 25 mg/linagliptin 5 mg or Linagliptin 5 mg + Placebo 25 mg after dose up-titration and who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment after dose up-titration.
Change from Week 28 in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at Week 28. Week 28 (pre up-titration) is referred to the last observed measurement prior to the first administration of any double-blind randomized trial medication in the up-titration period. Adjusted mean (Least square mean) and its standard error (SE) is presented. This endpoint was based on 1 group of the Full analysis set with up-titration (FASUT-II) whose dose was up-titrated to Empagliflozin 25 mg/Linagliptin 5 mg fixed dose combination thus there is no comparison group. Hence, no comparison is made. A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline eGFR, prior use of antidiabetic drug, visit as fixed effect(s). The covariance used to fit the model was unstructured.
Outcome measures
| Measure |
Empagliflozin 10 mg/Linagliptin 5 mg
n=124 Participants
Patients were administered a fixed dose combination (FDC) of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
Linagliptin 5 mg + Placebo 10 mg
Patients were administered a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
|---|---|---|
|
Change in HbA1c From Week 28 at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Only)
|
-0.21 Percentage (%)
Standard Error 0.03
|
—
|
SECONDARY outcome
Timeframe: Baseline and 52 weekPopulation: The analysis was performed on the FAS (observed case \[OC\]) with treatment assignment as randomised.
Change from baseline in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
Outcome measures
| Measure |
Empagliflozin 10 mg/Linagliptin 5 mg
n=182 Participants
Patients were administered a fixed dose combination (FDC) of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
Linagliptin 5 mg + Placebo 10 mg
n=93 Participants
Patients were administered a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
|---|---|---|
|
Change in HbA1c From Baseline at Week 52 (All Empagliflozin Versus All Placebo)
|
-1.16 Percentage (%)
Standard Error 0.06
|
0.06 Percentage (%)
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline and 52 weekPopulation: FASUT-I
Change from baseline in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
Outcome measures
| Measure |
Empagliflozin 10 mg/Linagliptin 5 mg
n=126 Participants
Patients were administered a fixed dose combination (FDC) of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
Linagliptin 5 mg + Placebo 10 mg
n=80 Participants
Patients were administered a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
|---|---|---|
|
Change in HbA1c From Baseline at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Versus Linagliptin 5 mg + Placebo 25 mg)
|
-1.10 Percentage (%)
Standard Error 0.07
|
0.11 Percentage (%)
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline and 52 weekPopulation: Full analysis set with up-titration-II consisted patients who were up-titrated to Empagliflozin 25/linagliptin 5 and were treated with at least 1 dose after dose up-titration and who were randomized to receive Linagliptin 5 + Placebo 10 or Linagliptin 5 + Placebo 25 and who had HbA1c assessment at baseline and at least once after dose up-titration.
Change from baseline in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
Outcome measures
| Measure |
Empagliflozin 10 mg/Linagliptin 5 mg
n=126 Participants
Patients were administered a fixed dose combination (FDC) of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
Linagliptin 5 mg + Placebo 10 mg
n=86 Participants
Patients were administered a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period.
|
|---|---|---|
|
Change in HbA1c From Baseline at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Versus All Placebo)
|
-1.10 Percentage (%)
Standard Error 0.07
|
-0.01 Percentage (%)
Standard Error 0.10
|
Adverse Events
All Empagliflozin
Serious events: 8 serious events
Other events: 62 other events
Deaths: 0 deaths
All Placebo
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Empagliflozin
n=182 participants at risk
Patients were administered a FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period. In the up-titration period (from Week 28 to Week 52), patients with insufficient response measured after 24 weeks of double-blind treatment got up-titrated to FDC of 25 mg Empagliflozin and 5 mg Linagliptin while the other patients kept the same dose.
|
All Placebo
n=93 participants at risk
Patients were administered a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period. In the up-titration period (from Week 28 to Week 52), patients with insufficient response measured after 24 weeks of double-blind treatment got up-titrated to matching placebo of FDC of 25 mg Empagliflozin and 5 mg Linagliptin while the other patients kept the same dose.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.55%
1/182 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
0.00%
0/93 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.55%
1/182 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
0.00%
0/93 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.55%
1/182 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
0.00%
0/93 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.55%
1/182 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
0.00%
0/93 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
|
Eye disorders
Glaucoma
|
0.55%
1/182 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
0.00%
0/93 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
|
Cardiac disorders
Prinzmetal angina
|
0.55%
1/182 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
0.00%
0/93 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.55%
1/182 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
0.00%
0/93 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/182 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
1.1%
1/93 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.55%
1/182 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
0.00%
0/93 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.55%
1/182 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
0.00%
0/93 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
Other adverse events
| Measure |
All Empagliflozin
n=182 participants at risk
Patients were administered a FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with matching placebo of Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period. In the up-titration period (from Week 28 to Week 52), patients with insufficient response measured after 24 weeks of double-blind treatment got up-titrated to FDC of 25 mg Empagliflozin and 5 mg Linagliptin while the other patients kept the same dose.
|
All Placebo
n=93 participants at risk
Patients were administered a matching placebo of FDC of 10 mg Empagliflozin and 5 mg Linagliptin tablet along with Linagliptin 5 mg orally once daily for 24 weeks of double-blind treatment period. In the up-titration period (from Week 28 to Week 52), patients with insufficient response measured after 24 weeks of double-blind treatment got up-titrated to matching placebo of FDC of 25 mg Empagliflozin and 5 mg Linagliptin while the other patients kept the same dose.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
19.2%
35/182 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
36.6%
34/93 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
7.1%
13/182 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
6.5%
6/93 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
7.7%
14/182 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
10.8%
10/93 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
|
Investigations
Blood ketone body increased
|
6.6%
12/182 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
1.1%
1/93 • From first drug administration till 52 weeks, up to 7 days after last drug administration.
TreatedSet(TS) included of patients who were randomised and treated with at least 1Dose of trial drug. Patients were randomized into 2Groups and remained in these groups after 28Weeks treatment. Patients got dose up-titrated after treatment,but had the same medication as it was before up-titrated.Data was reported for 2Arms based on randomization.
|
Additional Information
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