Trial Outcomes & Findings for A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus (NCT NCT01952145)
NCT ID: NCT01952145
Last Updated: 2019-01-03
Results Overview
Change from baseline in HbA1c after 26 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
557 participants
Primary outcome timeframe
Week 0, week 26
Results posted on
2019-01-03
Participant Flow
The trial was conducted at 75 sites in 10 countries as follows: Argentina: 5 sites; Australia: 4 sites; Greece: 6 sites, Hungary: 4 sites; Mexico: 5 sites, Russian Federation: 11 sites; Slovakia: 11 sites, South Africa: 4 sites; Spain: 6 sites, United States: 19 sites.
Subjects who were recruited had T2DM and were required to have been on treatment with stable daily dose of insulin glargine between 20 units and 50 units (both inclusive) for at least 56 days prior to screening in combination with a stable daily dose of metformin (≥1500 mg or max tolerated dose) for at least 90 days prior to screening.
Participant milestones
| Measure |
Insulin Degludec/Liraglutide (IDegLira)
Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were \>5.0 mmol/L (or \>90 mg/dL) and \<4.0 mmol/L (or \<71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
Insulin Glargine (IGlar)
Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
|---|---|---|
|
Overall Study
STARTED
|
278
|
279
|
|
Overall Study
COMPLETED
|
250
|
265
|
|
Overall Study
NOT COMPLETED
|
28
|
14
|
Reasons for withdrawal
| Measure |
Insulin Degludec/Liraglutide (IDegLira)
Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were \>5.0 mmol/L (or \>90 mg/dL) and \<4.0 mmol/L (or \<71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
Insulin Glargine (IGlar)
Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Adverse Event
|
9
|
0
|
|
Overall Study
Withdrawal Criteria
|
16
|
11
|
|
Overall Study
Unclassified
|
1
|
1
|
Baseline Characteristics
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Insulin Degludec/Liraglutide (IDegLira)
n=278 Participants
Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were \>5.0 mmol/L (or \>90 mg/dL) and \<4.0 mmol/L (or \<71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
Insulin Glargine (IGlar)
n=279 Participants
Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
Total
n=557 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 Years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
59.1 Years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
58.8 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Glycated hemoglobin (HbA1c)
|
8.4 Percentage (%)
STANDARD_DEVIATION 0.9 • n=5 Participants
|
8.2 Percentage (%)
STANDARD_DEVIATION 0.9 • n=7 Participants
|
8.3 Percentage (%)
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Body weight
|
88.3 Kg
STANDARD_DEVIATION 17.5 • n=5 Participants
|
87.3 Kg
STANDARD_DEVIATION 15.8 • n=7 Participants
|
87.8 Kg
STANDARD_DEVIATION 16.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 26Population: FAS was used for analysis of this endpoint. And FAS included all randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.
Change from baseline in HbA1c after 26 weeks of treatment
Outcome measures
| Measure |
Insulin Degludec/Liraglutide (IDegLira)
n=278 Participants
Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were \>5.0 mmol/L (or \>90 mg/dL) and \<4.0 mmol/L (or \<71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
Insulin Glargine (IGlar)
n=279 Participants
Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
|---|---|---|
|
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
|
-1.81 Percentage (%)
Standard Deviation 1.08
|
-1.13 Percentage (%)
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: FAS which included all randomised subjects was used for analysis of this endpoint. Missing values (including intermittent missing values) were imputed using LOCF method.
Change from baseline in body weight after 26 weeks of treatment
Outcome measures
| Measure |
Insulin Degludec/Liraglutide (IDegLira)
n=278 Participants
Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were \>5.0 mmol/L (or \>90 mg/dL) and \<4.0 mmol/L (or \<71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
Insulin Glargine (IGlar)
n=279 Participants
Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
|---|---|---|
|
Change From Baseline in Body Weight
|
-1.4 Kg
Standard Deviation 3.5
|
1.8 Kg
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: During 26 weeks of treatmentPopulation: The safety analysis set was used for analysis of this endpoint and this set included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated". Confirmed hypoglycaemic episodes were reported by 79 subjects in IdegLira arm and by 137 subjects in IGlar arm.
Confirmed hypoglycaemic episodes were defined as either: Severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or an episode biochemically confirmed by a plasma glucose value of \<3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide (IDegLira)
n=278 Participants
Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were \>5.0 mmol/L (or \>90 mg/dL) and \<4.0 mmol/L (or \<71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
Insulin Glargine (IGlar)
n=279 Participants
Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
|---|---|---|
|
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
|
289 Number of episodes
|
683 Number of episodes
|
Adverse Events
Insulin Degludec/Liraglutide (IDegLira)
Serious events: 5 serious events
Other events: 52 other events
Deaths: 0 deaths
Insulin Glargine (IGlar)
Serious events: 9 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Degludec/Liraglutide (IDegLira)
n=278 participants at risk
Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were \>5.0 mmol/L (or \>90 mg/dL) and \<4.0 mmol/L (or \<71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
Insulin Glargine (IGlar)
n=279 participants at risk
Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/278 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
0.36%
1/279 • Number of events 1 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/278 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
0.36%
1/279 • Number of events 1 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/278 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
0.36%
1/279 • Number of events 1 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Ear and labyrinth disorders
Auricular perichondritis
|
0.00%
0/278 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
0.36%
1/279 • Number of events 1 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/278 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
0.36%
1/279 • Number of events 1 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/278 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
0.36%
1/279 • Number of events 1 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/278 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
0.36%
1/279 • Number of events 1 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.36%
1/278 • Number of events 1 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
0.00%
0/279 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/278 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
0.36%
1/279 • Number of events 1 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/278 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
0.36%
1/279 • Number of events 1 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.36%
1/278 • Number of events 1 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
0.00%
0/279 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.36%
1/278 • Number of events 1 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
0.00%
0/279 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.36%
1/278 • Number of events 1 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
0.00%
0/279 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.36%
1/278 • Number of events 1 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
0.00%
0/279 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
Other adverse events
| Measure |
Insulin Degludec/Liraglutide (IDegLira)
n=278 participants at risk
Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were \>5.0 mmol/L (or \>90 mg/dL) and \<4.0 mmol/L (or \<71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
Insulin Glargine (IGlar)
n=279 participants at risk
Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0-5.0 mmol/L (71-90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
|
|---|---|---|
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Gastrointestinal disorders
Diarrhoea
|
7.2%
20/278 • Number of events 23 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
2.5%
7/279 • Number of events 10 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Nervous system disorders
Headache
|
4.0%
11/278 • Number of events 12 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
5.0%
14/279 • Number of events 28 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Gastrointestinal disorders
Nausea
|
9.4%
26/278 • Number of events 34 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
1.1%
3/279 • Number of events 3 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
14/278 • Number of events 22 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
|
1.8%
5/279 • Number of events 5 • Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment)
All AEs described below are treatment-emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Analysis population: safety analysis set.
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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 up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER