Trial Outcomes & Findings for Linagliptin as Add on to Basal Insulin in the Elderly (NCT NCT02240680)

Last Updated: 2018-07-03

Results Overview

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 randomised 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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

302 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2018-07-03

Participant Flow

This was randomised, double blinded, placebo controlled, parallel study. Total 525 patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control were screened. 302 patients were randomised into two groups. The trial was extended to 52 weeks for Japanese patients. 102 patients were identified and observed for the extended period.

All patients were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subject) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.

Participant milestones

Participant milestones
Measure	Placebo (Up to 24 Weeks) Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks	Linagliptin 5 Milligram (Up to 24 Weeks) Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.	Placebo (Up to 52 Weeks) Only Japanese patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 52 weeks	Linagliptin 5 Milligram (Up to 52 Weeks) Only Japanese patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 52 weeks
Overall Study (Up to 24 Weeks) STARTED	151	151	0	0
Overall Study (Up to 24 Weeks) COMPLETED	136	143	0	0
Overall Study (Up to 24 Weeks) NOT COMPLETED	15	8	0	0
Japanese Patients (Up to 52 Weeks) STARTED	0	0	50	52
Japanese Patients (Up to 52 Weeks) COMPLETED	0	0	42	45
Japanese Patients (Up to 52 Weeks) NOT COMPLETED	0	0	8	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo (Up to 24 Weeks) Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks	Linagliptin 5 Milligram (Up to 24 Weeks) Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.	Placebo (Up to 52 Weeks) Only Japanese patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 52 weeks	Linagliptin 5 Milligram (Up to 52 Weeks) Only Japanese patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 52 weeks
Overall Study (Up to 24 Weeks) Adverse Event	6	6	0	0
Overall Study (Up to 24 Weeks) Protocol Violation	4	1	0	0
Overall Study (Up to 24 Weeks) Lost to Follow-up	1	0	0	0
Overall Study (Up to 24 Weeks) Withdrawal by Subject	3	1	0	0
Overall Study (Up to 24 Weeks) Other than specified	1	0	0	0
Japanese Patients (Up to 52 Weeks) Adverse Event	0	0	6	7
Japanese Patients (Up to 52 Weeks) Protocol Violation	0	0	1	0
Japanese Patients (Up to 52 Weeks) Withdrawal by Subject	0	0	1	0

Baseline Characteristics

Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo (Up to 24 Weeks) n=151 Participants Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks	Linagliptin 5 Milligram (Up to 24 Weeks) n=151 Participants Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.	Total n=302 Participants Total of all reporting groups
Age, Continuous	72.5 Years STANDARD_DEVIATION 5.6 • n=151 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	72.3 Years STANDARD_DEVIATION 5.1 • n=151 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	72.4 Years STANDARD_DEVIATION 5.4 • n=302 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Sex: Female, Male Female	60 Participants n=151 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	59 Participants n=151 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	119 Participants n=302 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Sex: Female, Male Male	91 Participants n=151 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	92 Participants n=151 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	183 Participants n=302 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=151 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	15 Participants n=151 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	34 Participants n=302 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Ethnicity (NIH/OMB) Not Hispanic or Latino	132 Participants n=151 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	136 Participants n=151 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	268 Participants n=302 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=151 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0 Participants n=151 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0 Participants n=302 Participants • Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Race (NIH/OMB) American Indian or Alaska Native	7 Participants n=151 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	4 Participants n=151 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	11 Participants n=302 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Race (NIH/OMB) Asian	52 Participants n=151 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	52 Participants n=151 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	104 Participants n=302 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=151 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	1 Participants n=151 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	1 Participants n=302 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Race (NIH/OMB) Black or African American	10 Participants n=151 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	8 Participants n=151 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	18 Participants n=302 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Race (NIH/OMB) White	81 Participants n=151 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	84 Participants n=151 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	165 Participants n=302 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Race (NIH/OMB) More than one race	1 Participants n=151 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	2 Participants n=151 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	3 Participants n=302 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=151 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0 Participants n=151 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0 Participants n=302 Participants • Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Hemoglobin A1c (HbA1c) at baseline	8.1 Percentage of HbA1c (%) STANDARD_DEVIATION 0.7 • n=147 Participants • Full analysis set (FAS): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value.	8.2 Percentage of HbA1c (%) STANDARD_DEVIATION 0.8 • n=149 Participants • Full analysis set (FAS): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value.	8.2 Percentage of HbA1c (%) STANDARD_DEVIATION 0.8 • n=296 Participants • Full analysis set (FAS): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value.

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set observed cases (FAS (OC)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. These analyses used available data as observed while patients were on treatment. All values collected after a patient started rescue medication were excluded from the analysis.

Outcome measures

Outcome measures
Measure	Placebo (Up to 24 Weeks) n=147 Participants Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks	Linagliptin 5 Milligram (Up to 24 Weeks) n=149 Participants Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.
Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.	-0.38 Percentage (%) of HbA1c Standard Error 0.07	-1.01 Percentage (%) of HbA1c Standard Error 0.06

SECONDARY outcome

Timeframe: 24 weeks

Hypoglycaemia accompanied by a prespecified glucose value is defined as any investigator reported hypoglycaemia (event or AE) with a reported blood glucose level of less than 54 milligram/deciLitre (3.0 millimole/Litre) or any investigator reported symptomatic hypoglycaemic AE with a reported blood glucose level of less or equal 70 milligram/deciLitre (3.9millimole/Litre) or any severe hypoglycaemic AE. Severe hypoglycaemia is an event that requires the assistance of another person to actively administer carbohydrates or glucagon because the patient is unable to take the substance on his or her own. The confidence intervals mentioned in measure of dispersion are exact 95% confidence interval by Clopper and Pearson. The percentage of patients with at least one hypoglycaemia accompanied by a glucose value less than 54mg/dL alone has also represented separately according American Diabetes Association definition of clinically significant hypoglycaemia.

Outcome measures

Outcome measures
Measure	Placebo (Up to 24 Weeks) n=147 Participants Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks	Linagliptin 5 Milligram (Up to 24 Weeks) n=149 Participants Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.
Percentage of Patients Experiencing at Least One Hypoglycaemia Accompanied by a Prespecified Glucose Value. Prespecified glucose value	23.8 Percentage of patients (%) Interval 17.2 to 31.5	30.9 Percentage of patients (%) Interval 23.6 to 39.0
Percentage of Patients Experiencing at Least One Hypoglycaemia Accompanied by a Prespecified Glucose Value. Glucose value <54 mg/dL	15.0 Percentage of patients (%) Interval 9.6 to 21.8	16.8 Percentage of patients (%) Interval 11.2 to 23.8

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set (Non-completers considered failure)(FAS (NCF)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. This analyses regarded missing values for binary efficacy endpoints as failure.

This is the percentage of patients with HbA1c on treatment \<8.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.

Outcome measures

Outcome measures
Measure	Placebo (Up to 24 Weeks) n=147 Participants Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks	Linagliptin 5 Milligram (Up to 24 Weeks) n=149 Participants Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.
Percentage of Patients With HbA1c<8.0%	40.2 Percentage of patients (%) Interval 29.9 to 51.3	70.1 Percentage of patients (%) Interval 59.4 to 79.5

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set non-completers considered failure (FAS (NCF)): Includes all patients randomised in the treated set who had a baseline and at least one on-treatment HbA1c value. This analyses regarded missing values for binary efficacy endpoints as failure.

This is the percentage of patients with HbA1c on treatment \<7.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.

Outcome measures

Outcome measures
Measure	Placebo (Up to 24 Weeks) n=147 Participants Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks	Linagliptin 5 Milligram (Up to 24 Weeks) n=149 Participants Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.
Percentage of Patients With HbA1c on Treatment <7.0%	14.6 Percentage of Patients (%) Interval 9.3 to 21.4	37.8 Percentage of Patients (%) Interval 29.8 to 46.2

SECONDARY outcome

Timeframe: 24 weeks

The percentage of patients who attained lowering of HbA1c by ≥0.5% from baseline after 24 weeks of treatment were analysed. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.

Outcome measures

Outcome measures
Measure	Placebo (Up to 24 Weeks) n=147 Participants Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks	Linagliptin 5 Milligram (Up to 24 Weeks) n=149 Participants Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.
Percentage of Patients With HbA1c Lowering by at Least 0.5%.	37.4 Percentage of patients (%) Interval 29.6 to 45.8	69.1 Percentage of patients (%) Interval 61.0 to 76.4

SECONDARY outcome

Timeframe: Baseline and Week 24

This outcome has measured difference between FPG values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication

Outcome measures

Outcome measures
Measure	Placebo (Up to 24 Weeks) n=147 Participants Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks	Linagliptin 5 Milligram (Up to 24 Weeks) n=149 Participants Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.
Change From Baseline in Fasting Plasma Glucose (FPG)	0.2 milligram/decilitre Standard Error 3.6	-11.3 milligram/decilitre Standard Error 3.3

Adverse Events

Placebo (Up to 24 Weeks)

Serious events: 21 serious events

Other events: 58 other events

Deaths: 0 deaths

Linagliptin 5 mg (Up to 24 Weeks)

Serious events: 19 serious events

Other events: 72 other events

Deaths: 2 deaths

Placebo (Up to 52 Weeks)

Serious events: 7 serious events

Other events: 19 other events

Deaths: 0 deaths

Linagliptin 5mg (Up to 52 Weeks)

Serious events: 13 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo (Up to 24 Weeks) n=151 participants at risk Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks	Linagliptin 5 mg (Up to 24 Weeks) n=151 participants at risk Patients were orally administered with Linagliptin 5 mg film-coated tablets once daily up to 24 weeks.	Placebo (Up to 52 Weeks) n=50 participants at risk Japanese patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 52 weeks	Linagliptin 5mg (Up to 52 Weeks) n=52 participants at risk Japanese patients were orally administered with Linagliptin 5 mg film-coated tablets once daily up to 52 weeks.
Gastrointestinal disorders Constipation	0.66% 1/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	1.3% 2/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/50 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	5.8% 3/52 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Large intestine polyp	0.00% 0/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	1.3% 2/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/50 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	5.8% 3/52 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Bronchitis	2.6% 4/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	4.6% 7/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/50 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	9.6% 5/52 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Urinary tract infection	6.0% 9/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	6.6% 10/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	2.0% 1/50 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	1.9% 1/52 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Viral upper respiratory tract infection	5.3% 8/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	7.3% 11/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	6.0% 3/50 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	21.2% 11/52 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Hypoglycaemia	25.2% 38/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	33.8% 51/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	28.0% 14/50 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	38.5% 20/52 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Back pain	4.0% 6/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	3.3% 5/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	6.0% 3/50 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	3.8% 2/52 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.66% 1/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	2.0% 3/151 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/50 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	5.8% 3/52 • The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration. An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.

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