Trial Outcomes & Findings for Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes (NCT NCT01973231)
NCT ID: NCT01973231
Last Updated: 2017-02-09
Results Overview
Change from baseline in HbA1c after 26 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
404 participants
Primary outcome timeframe
Week 0, week 26
Results posted on
2017-02-09
Participant Flow
The trial was conducted at 56 sites in 9 countries; Czech Republic (5), Finland (4), France (6), Germany (8), Hungary (6), Italy (5), Latvia (6), Lithuania (5) and UK (11).
Participant milestones
| Measure |
Liraglutide
Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
|
Lixisenatide
Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
|
|---|---|---|
|
Overall Study
STARTED
|
202
|
202
|
|
Overall Study
COMPLETED
|
191
|
190
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
Reasons for withdrawal
| Measure |
Liraglutide
Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
|
Lixisenatide
Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
unclassified
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
9
|
Baseline Characteristics
Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Liraglutide
n=202 Participants
Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
|
Lixisenatide
n=202 Participants
Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
|
Total
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
56.1 years
STANDARD_DEVIATION 10.0 • n=107 Participants
|
56.2 years
STANDARD_DEVIATION 10.3 • n=206 Participants
|
|
Gender
Female
|
70 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Gender
Male
|
132 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
244 Participants
n=206 Participants
|
|
Glycosylated Haemoglobin (HbA1c)
|
8.40 Percent (%) glycosylated haemoglobin
STANDARD_DEVIATION 0.723 • n=99 Participants
|
8.43 Percent (%) glycosylated haemoglobin
STANDARD_DEVIATION 0.785 • n=107 Participants
|
8.41 Percent (%) glycosylated haemoglobin
STANDARD_DEVIATION 0.754 • n=206 Participants
|
|
Fasting plasma glucose (FPG)
|
10.47 mmol/L
STANDARD_DEVIATION 2.368 • n=99 Participants
|
10.25 mmol/L
STANDARD_DEVIATION 2.254 • n=107 Participants
|
10.36 mmol/L
STANDARD_DEVIATION 2.312 • n=206 Participants
|
|
Body Weight
|
101.89 kg
STANDARD_DEVIATION 23.344 • n=99 Participants
|
100.58 kg
STANDARD_DEVIATION 19.949 • n=107 Participants
|
101.24 kg
STANDARD_DEVIATION 21.696 • n=206 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 26Population: The full analysis set (FAS) included all randomised subjects. Missing values were imputed using predicted values from the mixed model for repeated measurements (MMRM) model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.
Change from baseline in HbA1c after 26 weeks of treatment.
Outcome measures
| Measure |
Liraglutide
n=194 Participants
Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
|
Lixisenatide
n=191 Participants
Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
|
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c) From Baseline
|
-1.809 Percent (%) glycosylated haemoglobin
Standard Deviation 0.9159
|
-1.238 Percent (%) glycosylated haemoglobin
Standard Deviation 1.0085
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing FPG post baseline data, 194 and 189 subjects in liraglutide and lixisenatide treatment group, respectively were included in the FPG analysis.
Change from baseline in FPG after 26 weeks of treatment.
Outcome measures
| Measure |
Liraglutide
n=194 Participants
Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
|
Lixisenatide
n=189 Participants
Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Baseline
|
-2.904 mmol/L
Standard Deviation 2.2309
|
-1.644 mmol/L
Standard Deviation 2.1511
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing body weight post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the body weight analysis.
Change from baseline in body weight after 26 weeks of treatment.
Outcome measures
| Measure |
Liraglutide
n=194 Participants
Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
|
Lixisenatide
n=191 Participants
Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
|
|---|---|---|
|
Change in Body Weight From Baseline
|
-4.24 kg
Standard Deviation 4.273
|
-3.69 kg
Standard Deviation 4.746
|
SECONDARY outcome
Timeframe: After 26 weeks of treatmentPopulation: The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.
Subjects who achieved HbA1c below 7.0% (53 mmol/mol) after 26 weeks of treatment (yes/no).
Outcome measures
| Measure |
Liraglutide
n=194 Participants
Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
|
Lixisenatide
n=191 Participants
Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
|
|---|---|---|
|
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)
Yes
|
74.2 percentage (%) of subjects
|
45.5 percentage (%) of subjects
|
|
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)
No
|
25.8 percentage (%) of subjects
|
54.5 percentage (%) of subjects
|
SECONDARY outcome
Timeframe: After 26 weeks of treatmentPopulation: The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.
Subjects who achieved HbA1c below equal to or below 6.5% (48 mmol/mol) after 26 weeks of treatment (yes/no).
Outcome measures
| Measure |
Liraglutide
n=194 Participants
Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
|
Lixisenatide
n=191 Participants
Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
|
|---|---|---|
|
Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no)
Yes
|
54.6 percentage (%) of subjects
|
26.2 percentage (%) of subjects
|
|
Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no)
No
|
45.4 percentage (%) of subjects
|
73.8 percentage (%) of subjects
|
SECONDARY outcome
Timeframe: After 26 weeks of treatmentPopulation: The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post-baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.
Subjects who achieved HbA1c below 7.0% (53 mmol/mol) and no weight gain after 26 weeks of treatment (yes/no).
Outcome measures
| Measure |
Liraglutide
n=194 Participants
Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
|
Lixisenatide
n=191 Participants
Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
|
|---|---|---|
|
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no)
Yes
|
66.5 percentage (%) of subjects
|
41.9 percentage (%) of subjects
|
|
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no)
No
|
33.5 percentage (%) of subjects
|
58.1 percentage (%) of subjects
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: The safety analysis set (SAS) included all subjects who received at least one dose of any of the trial products.
A Treatment Emergent Adverse Event (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. Severity was assessed by investigator.
Outcome measures
| Measure |
Liraglutide
n=202 Participants
Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
|
Lixisenatide
n=202 Participants
Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
|
|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Events
|
540 events
|
435 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Serious
|
13 events
|
7 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Severe
|
10 events
|
3 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Moderate
|
109 events
|
84 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Mild
|
421 events
|
348 events
|
Adverse Events
Liraglutide
Serious events: 12 serious events
Other events: 90 other events
Deaths: 0 deaths
Lixisenatide
Serious events: 7 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liraglutide
n=202 participants at risk
Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
|
Lixisenatide
n=202 participants at risk
Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
General disorders
Pyrexia
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Infections and infestations
Diabetic foot infection
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Infections and infestations
Influenza
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Nervous system disorders
Ischaemic stroke
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Nervous system disorders
Syncope
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Reproductive system and breast disorders
Prostatic dysplasia
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.50%
1/202 • Number of events 1 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/202 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
Other adverse events
| Measure |
Liraglutide
n=202 participants at risk
Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
|
Lixisenatide
n=202 participants at risk
Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.4%
25/202 • Number of events 39 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
9.9%
20/202 • Number of events 22 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.4%
11/202 • Number of events 11 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
3.0%
6/202 • Number of events 9 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Gastrointestinal disorders
Nausea
|
21.8%
44/202 • Number of events 67 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
21.8%
44/202 • Number of events 60 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
14/202 • Number of events 18 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
8.9%
18/202 • Number of events 22 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
13/202 • Number of events 13 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
9.9%
20/202 • Number of events 22 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Investigations
Lipase increased
|
8.4%
17/202 • Number of events 17 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
2.5%
5/202 • Number of events 5 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.4%
13/202 • Number of events 13 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
2.5%
5/202 • Number of events 5 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
|
Nervous system disorders
Headache
|
7.4%
15/202 • Number of events 31 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
8.4%
17/202 • Number of events 35 • Weeks 0-26
The SAS included all subjects who received at least one dose of any of the trial products.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk maintains the right to be informed of plans by any investigator to publish and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager before submission for comments. Comments will be given within four weeks from receipt of the planned communication.
- Publication restrictions are in place
Restriction type: OTHER