Trial Outcomes & Findings for Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin (NCT NCT01907854)
NCT ID: NCT01907854
Last Updated: 2018-10-02
Results Overview
Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
407 participants
Primary outcome timeframe
From baseline to week 26
Results posted on
2018-10-02
Participant Flow
The trial was conducted at 86 sites in 6 countries: Canada (14); Hungary (8); India (7); Israel (8); Spain (6); and United States (43).
Screening details: Subjects were adult males or females with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control with stable doses of sitagliptin and metformin for 90 days prior to screening.
Participant milestones
| Measure |
Liraglutide
Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \[under the skin\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose
≥1000 mg/day\]) + OD sitagliptin placebo tablets.
|
Sitagliptin
Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose ≥1000 mg/day\]) + OD s.c., injection of liraglutide placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
204
|
|
Overall Study
Exposed
|
202
|
204
|
|
Overall Study
COMPLETED
|
187
|
191
|
|
Overall Study
NOT COMPLETED
|
16
|
13
|
Reasons for withdrawal
| Measure |
Liraglutide
Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \[under the skin\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose
≥1000 mg/day\]) + OD sitagliptin placebo tablets.
|
Sitagliptin
Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose ≥1000 mg/day\]) + OD s.c., injection of liraglutide placebo.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
7
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Unclassified
|
4
|
3
|
Baseline Characteristics
Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin
Baseline characteristics by cohort
| Measure |
Liraglutide
n=202 Participants
Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \[under the skin\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose
≥1000 mg/day\]) + OD sitagliptin placebo tablets.
|
Sitagliptin
n=204 Participants
Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose ≥1000 mg/day\]) + OD s.c., injection of liraglutide placebo.
|
Total
n=406 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
56.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
HbA1c
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.6 • n=5 Participants
|
8.2 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.6 • n=7 Participants
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Body Weight
|
88.9 kg
STANDARD_DEVIATION 19.8 • n=5 Participants
|
91.2 kg
STANDARD_DEVIATION 19.6 • n=7 Participants
|
90.1 kg
STANDARD_DEVIATION 19.7 • n=5 Participants
|
|
Fasting Plasma Glucose
|
10.0 mmol/L
STANDARD_DEVIATION 2.7 • n=5 Participants
|
9.7 mmol/L
STANDARD_DEVIATION 2.5 • n=7 Participants
|
9.9 mmol/L
STANDARD_DEVIATION 2.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 26Population: Full analysis set (FAS) -All randomised subjects receiving at least one dose of any of the trial product.
Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM).
Outcome measures
| Measure |
Liraglutide
n=176 Participants
Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \[under the skin\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose
≥1000 mg/day\]) + OD sitagliptin placebo tablets.
|
Sitagliptin
n=182 Participants
Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose ≥1000 mg/day\]) + OD s.c., injection of liraglutide placebo.
|
|---|---|---|
|
Change in HbA1c (Glycosylated Haemoglobin)
|
-1.146 percentage of glycosylated haemoglobin
Standard Deviation 0.9748
|
-0.529 percentage of glycosylated haemoglobin
Standard Deviation 1.0148
|
SECONDARY outcome
Timeframe: From baseline to week 26Population: FAS - All randomised subjects receiving at least one dose of any of the trial product.
Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: FAS: all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM.
Outcome measures
| Measure |
Liraglutide
n=192 Participants
Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \[under the skin\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose
≥1000 mg/day\]) + OD sitagliptin placebo tablets.
|
Sitagliptin
n=200 Participants
Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose ≥1000 mg/day\]) + OD s.c., injection of liraglutide placebo.
|
|---|---|---|
|
Change in Body Weight
|
-3.32 kg
Standard Deviation 3.135
|
-1.80 kg
Standard Deviation 2.974
|
SECONDARY outcome
Timeframe: From baseline to week 26Population: FAS - All randomised subjects receiving at least one dose of any of the trial product.
Change from baseline in fasting plasma glucose was analysed after 26 weeks of treatment. Missing values were imputed using MMRM.
Outcome measures
| Measure |
Liraglutide
n=190 Participants
Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \[under the skin\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose
≥1000 mg/day\]) + OD sitagliptin placebo tablets.
|
Sitagliptin
n=199 Participants
Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose ≥1000 mg/day\]) + OD s.c., injection of liraglutide placebo.
|
|---|---|---|
|
Change in Fasting Plasma Glucose
|
-1.967 nmol/L
Standard Deviation 2.3585
|
-0.588 nmol/L
Standard Deviation 2.1363
|
SECONDARY outcome
Timeframe: From baseline to week 26Population: FAS-All randomised subjects receiving at least one dose of any of the trial product. There were missing baseline values for free fatty acids in 1 subject in the liraglutide arm and 6 subjects in the sitagliptin arm.
Ratio to baseline in fasting blood lipids (total cholesterol, low density lipoprotein \[LDL\], very low density lipoprotein \[VLDL\], high density lipoprotein \[HDL\], triglycerides, and free fatty acids) were analysed after 26 weeks treatment. Missing values were imputed using MMRM. Here we are presenting ratio to baseline data.
Outcome measures
| Measure |
Liraglutide
n=155 Participants
Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \[under the skin\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose
≥1000 mg/day\]) + OD sitagliptin placebo tablets.
|
Sitagliptin
n=156 Participants
Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose ≥1000 mg/day\]) + OD s.c., injection of liraglutide placebo.
|
|---|---|---|
|
Change in Fasting Blood Lipids
Total cholesterol
|
1.011 ratio
Standard Deviation 0.1906
|
1.045 ratio
Standard Deviation 0.2323
|
|
Change in Fasting Blood Lipids
LDL cholesterol
|
1.049 ratio
Standard Deviation 0.3899
|
1.121 ratio
Standard Deviation 0.4661
|
|
Change in Fasting Blood Lipids
VLDL cholesterol
|
1.062 ratio
Standard Deviation 0.4236
|
1.075 ratio
Standard Deviation 0.4625
|
|
Change in Fasting Blood Lipids
HDL cholesterol
|
1.004 ratio
Standard Deviation 0.1528
|
0.997 ratio
Standard Deviation 0.1548
|
|
Change in Fasting Blood Lipids
Triglycerides
|
1.089 ratio
Standard Deviation 0.4975
|
1.099 ratio
Standard Deviation 0.4889
|
|
Change in Fasting Blood Lipids
Free Fatty acids
|
1.086 ratio
Standard Deviation 0.774
|
1.104 ratio
Standard Deviation 0.5839
|
SECONDARY outcome
Timeframe: From baseline to week 26Population: FAS - All randomised subjects receiving at least one dose of any of the trial product
Change from baseline in systolic and diastolic blood pressure were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.
Outcome measures
| Measure |
Liraglutide
n=192 Participants
Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \[under the skin\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose
≥1000 mg/day\]) + OD sitagliptin placebo tablets.
|
Sitagliptin
n=200 Participants
Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose ≥1000 mg/day\]) + OD s.c., injection of liraglutide placebo.
|
|---|---|---|
|
Change in Systolic Blood Pressure and Diastolic Blood Pressure
Systolic Blood Pressure
|
-3.6 mmHg
Standard Deviation 11.596
|
-2.57 mmHg
Standard Deviation 11.593
|
|
Change in Systolic Blood Pressure and Diastolic Blood Pressure
Diastolic Blood Pressure
|
-0.23 mmHg
Standard Deviation 7.085
|
-0.81 mmHg
Standard Deviation 7.193
|
SECONDARY outcome
Timeframe: After 26 weeks of treatmentPopulation: FAS-All randomised subjects receiving at least one dose of any of the trial product.
Number of subjects who achieve HbA1c \<7.0% were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.
Outcome measures
| Measure |
Liraglutide
n=176 Participants
Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \[under the skin\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose
≥1000 mg/day\]) + OD sitagliptin placebo tablets.
|
Sitagliptin
n=182 Participants
Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose ≥1000 mg/day\]) + OD s.c., injection of liraglutide placebo.
|
|---|---|---|
|
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)
Yes
|
50.6 percentage (%)
|
26.9 percentage (%)
|
|
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)
No
|
49.4 percentage (%)
|
73.1 percentage (%)
|
SECONDARY outcome
Timeframe: During 26 weeks of treatment plus one week follow-up period.Population: Safety analysis set-All randomised subjects receiving at least one dose of any of the trial product.
A treatment emergent adverse event (TEAE) was defined as an event that had an onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. The number of TEAEs was recorded during 26 weeks of treatment plus one week follow-up period.
Outcome measures
| Measure |
Liraglutide
n=202 Participants
Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \[under the skin\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose
≥1000 mg/day\]) + OD sitagliptin placebo tablets.
|
Sitagliptin
n=204 Participants
Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose ≥1000 mg/day\]) + OD s.c., injection of liraglutide placebo.
|
|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs)
|
455 number of events
|
318 number of events
|
Adverse Events
Liraglutide
Serious events: 6 serious events
Other events: 96 other events
Deaths: 0 deaths
Sitagliptin
Serious events: 7 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liraglutide
n=202 participants at risk
Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \[under the skin\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose
≥1000 mg/day\]) + OD sitagliptin placebo tablets.
|
Sitagliptin
n=204 participants at risk
Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose ≥1000 mg/day\]) + OD s.c., injection of liraglutide placebo.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.50%
1/202 • Number of events 1 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/204 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.50%
1/202 • Number of events 1 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/204 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/202 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
0.49%
1/204 • Number of events 1 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Cardiac disorders
Prinzmetal angina
|
0.50%
1/202 • Number of events 1 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/204 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/202 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
0.49%
1/204 • Number of events 1 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/202 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
0.49%
1/204 • Number of events 1 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Infections and infestations
Pneumonia
|
0.50%
1/202 • Number of events 1 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
0.49%
1/204 • Number of events 1 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Injury, poisoning and procedural complications
Fall
|
0.99%
2/202 • Number of events 2 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/204 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/202 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
0.49%
1/204 • Number of events 1 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/202 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
0.49%
1/204 • Number of events 1 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/202 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
0.49%
1/204 • Number of events 1 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Psychiatric disorders
Depression
|
0.50%
1/202 • Number of events 1 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/204 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/202 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
0.49%
1/204 • Number of events 1 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.50%
1/202 • Number of events 1 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
0.00%
0/204 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that 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
Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., \[under the skin\] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose
≥1000 mg/day\]) + OD sitagliptin placebo tablets.
|
Sitagliptin
n=204 participants at risk
Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day \[or documented maximum tolerated dose ≥1000 mg/day\]) + OD s.c., injection of liraglutide placebo.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
16.3%
33/202 • Number of events 45 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
9.3%
19/204 • Number of events 21 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that 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 59 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
7.8%
16/204 • Number of events 21 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
15/202 • Number of events 18 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
4.9%
10/204 • Number of events 15 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
12/202 • Number of events 14 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
3.4%
7/204 • Number of events 7 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
12/202 • Number of events 12 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
6.4%
13/204 • Number of events 15 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Investigations
Lipase increased
|
5.4%
11/202 • Number of events 12 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
4.4%
9/204 • Number of events 9 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.9%
18/202 • Number of events 18 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
3.4%
7/204 • Number of events 7 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
|
Nervous system disorders
Headache
|
6.4%
13/202 • Number of events 16 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
|
5.9%
12/204 • Number of events 16 • 27 weeks (26 weeks of treatment period + 1 week of follow-up)
Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more public disclosures 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. The results of this trial will be subject to public disclosure on external web sites according to international regulations, as reflected in the Novo Nordisk Code of Conduct for Clinical Trial Disclosure.
- Publication restrictions are in place
Restriction type: OTHER