Trial Outcomes & Findings for A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms (NCT NCT02298192)
NCT ID: NCT02298192
Last Updated: 2017-05-23
Results Overview
Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
420 participants
Primary outcome timeframe
Week 0, week 32
Results posted on
2017-05-23
Participant Flow
The trial was conducted at 80 sites in 9 countries as follows:Austria: 6 sites; Bulgaria: 5 sites; Canada: 7 sites, Czech Republic:5 sites; Hungary: 4 sites, Russian Federation: 6 sites; Serbia: 4sites, Slovakia: 7 sites; United States: 36 sites.
Stable daily treatment with metformin (≥1500 mg or max tolerated dose) ± pioglitazone (≥30 mg) for at least 90 days prior to screening
Participant milestones
| Measure |
IDegLira (1WT)
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
|
IDegLira
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
|
|---|---|---|
|
Overall Study
STARTED
|
210
|
210
|
|
Overall Study
COMPLETED
|
191
|
204
|
|
Overall Study
NOT COMPLETED
|
19
|
6
|
Reasons for withdrawal
| Measure |
IDegLira (1WT)
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
|
IDegLira
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
|
|---|---|---|
|
Overall Study
Unclassified
|
3
|
2
|
|
Overall Study
Withdrawal criteria
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Adverse Event
|
6
|
2
|
Baseline Characteristics
A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms
Baseline characteristics by cohort
| Measure |
IDegLira (1WT)
n=210 Participants
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
|
IDegLira
n=210 Participants
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
56.8 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
HbA1c
|
8.2 percentage
STANDARD_DEVIATION 0.9 • n=5 Participants
|
8.1 percentage
STANDARD_DEVIATION 0.9 • n=7 Participants
|
8.1 percentage
STANDARD_DEVIATION 0.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 32Population: Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.
Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment.
Outcome measures
| Measure |
IDegLira (1WT)
n=189 Participants
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
|
IDegLira
n=200 Participants
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
|
|---|---|---|
|
Change From Baseline in HbA1c
|
-2.01 percentage
Standard Deviation 1.09
|
-2.02 percentage
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Week 0, week 32Population: Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.
Responders to HbA1c below 7% after 32 weeks of treatment.
Outcome measures
| Measure |
IDegLira (1WT)
n=189 Participants
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
|
IDegLira
n=200 Participants
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
|
|---|---|---|
|
HbA1c Below 7.0%
yes
|
170 participants
|
179 participants
|
|
HbA1c Below 7.0%
No
|
19 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Week 0, week 32Population: Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.
Responders to HbA1c below or equal to 6.5% after 32 weeks of treatment.
Outcome measures
| Measure |
IDegLira (1WT)
n=189 Participants
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
|
IDegLira
n=200 Participants
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
|
|---|---|---|
|
HbA1c Below or Equal to 6.5%
No
|
31 particpants
|
30 particpants
|
|
HbA1c Below or Equal to 6.5%
yes
|
158 particpants
|
170 particpants
|
SECONDARY outcome
Timeframe: Week 0-32Population: Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated". One subject in the IDegLira (1WT) arm did not contribute to the analysis for this endpoint.
An episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Outcome measures
| Measure |
IDegLira (1WT)
n=209 Participants
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
|
IDegLira
n=210 Participants
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
|
|---|---|---|
|
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
|
20 Number of episodes
|
97 Number of episodes
|
Adverse Events
IDegLira (1WT)
Serious events: 7 serious events
Other events: 24 other events
Deaths: 0 deaths
IDegLira
Serious events: 14 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDegLira (1WT)
n=209 participants at risk
Subjects received IDegLira once weekly in combination with metformin alone or in combination with pioglitazone in a 1:1 manner at visit 2 and were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), and the maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).The daily dose for metformin (≥1500 mg or max tolerated dose) and pioglitazone (≥30 mg) The dose of IDegLira was to be adjusted once weekly based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on the titration day. The first dose of trial product was to be administered either on the day of randomisation (visit 2) or the day after.
|
IDegLira
n=210 participants at risk
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/209 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.95%
2/210 • Number of events 2 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/209 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.48%
1/210 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Investigations
Blood glucose increased
|
0.00%
0/209 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.48%
1/210 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Infections and infestations
Cellulitis
|
0.00%
0/209 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.48%
1/210 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/209 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.48%
1/210 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/209 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.48%
1/210 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Gastrointestinal disorders
Colitis
|
0.48%
1/209 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.00%
0/210 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.48%
1/209 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.00%
0/210 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Gastrointestinal disorders
Enteritis
|
0.48%
1/209 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.00%
0/210 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/209 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.48%
1/210 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/209 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.48%
1/210 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.48%
1/209 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.00%
0/210 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Vascular disorders
Hypotension
|
0.48%
1/209 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.00%
0/210 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/209 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.48%
1/210 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Nervous system disorders
Migraine
|
0.48%
1/209 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.00%
0/210 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/209 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.95%
2/210 • Number of events 2 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
General disorders
Non-cardiac chest pain
|
0.48%
1/209 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.00%
0/210 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.48%
1/209 • Number of events 2 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.00%
0/210 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Infections and infestations
Pneumonia
|
0.00%
0/209 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.48%
1/210 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/209 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.48%
1/210 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/209 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.48%
1/210 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.48%
1/209 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.00%
0/210 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/209 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.48%
1/210 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/209 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
0.48%
1/210 • Number of events 1 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
Other adverse events
| Measure |
IDegLira (1WT)
n=209 participants at risk
Subjects received IDegLira once weekly in combination with metformin alone or in combination with pioglitazone in a 1:1 manner at visit 2 and were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), and the maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).The daily dose for metformin (≥1500 mg or max tolerated dose) and pioglitazone (≥30 mg) The dose of IDegLira was to be adjusted once weekly based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on the titration day. The first dose of trial product was to be administered either on the day of randomisation (visit 2) or the day after.
|
IDegLira
n=210 participants at risk
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.2%
13/209 • Number of events 16 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
4.3%
9/210 • Number of events 13 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
|
Gastrointestinal disorders
Nausea
|
5.3%
11/209 • Number of events 16 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
5.2%
11/210 • Number of events 20 • Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated".
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator (s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for upto 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER