Trial Outcomes & Findings for Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes (NCT NCT00789191)
NCT ID: NCT00789191
Last Updated: 2017-03-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
222 participants
Primary outcome timeframe
Week 26
Results posted on
2017-03-14
Participant Flow
48 sites in 8 countries: Canada, Finland, France, Hungary, Slovakia, Republic of Korea, Turkey, and the United States of America (USA)
Between screening and randomisation, eligible subjects were to continue their usual pre-trial oral anti-diabetic drug (OAD) dose and dosing frequency. Subjects on sulphonylurea (SU) treatment randomised to the insulin detemir group had their SU discontinued
Participant milestones
| Measure |
Comb
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
111
|
|
Overall Study
Exposed
|
107
|
110
|
|
Overall Study
COMPLETED
|
97
|
92
|
|
Overall Study
NOT COMPLETED
|
14
|
19
|
Reasons for withdrawal
| Measure |
Comb
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Lack of Efficacy
|
0
|
5
|
|
Overall Study
Protocol Violation
|
5
|
3
|
|
Overall Study
Withdrawal Criteria
|
2
|
4
|
|
Overall Study
Unclassified
|
5
|
3
|
Baseline Characteristics
Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Comb
n=107 Participants
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
n=110 Participants
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.70 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
57.10 years
STANDARD_DEVIATION 8.41 • n=7 Participants
|
56.90 years
STANDARD_DEVIATION 9.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
HbA1c
|
8.52 Percent (%) glycosylated haemoglobin
STANDARD_DEVIATION 0.65 • n=5 Participants
|
8.52 Percent (%) glycosylated haemoglobin
STANDARD_DEVIATION 0.65 • n=7 Participants
|
8.52 Percent (%) glycosylated haemoglobin
STANDARD_DEVIATION 0.65 • n=5 Participants
|
|
Height
|
1.71 meters
STANDARD_DEVIATION 0.10 • n=5 Participants
|
1.66 meters
STANDARD_DEVIATION 0.09 • n=7 Participants
|
1.68 meters
STANDARD_DEVIATION 0.10 • n=5 Participants
|
|
Body Weight
|
93.1 kg
STANDARD_DEVIATION 20.2 • n=5 Participants
|
88.2 kg
STANDARD_DEVIATION 19.2 • n=7 Participants
|
90.6 kg
STANDARD_DEVIATION 19.8 • n=5 Participants
|
|
BMI
|
31.79 kg/m^2
STANDARD_DEVIATION 5.20 • n=5 Participants
|
31.90 kg/m^2
STANDARD_DEVIATION 5.91 • n=7 Participants
|
31.85 kg/m^2
STANDARD_DEVIATION 5.56 • n=5 Participants
|
|
Stratification
Previous Metformin + Other OAD therapy
|
83 participants
n=5 Participants
|
86 participants
n=7 Participants
|
169 participants
n=5 Participants
|
|
Stratification
Previous Metformin Monotherapy
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
FPG
|
9.69 mmol/L
STANDARD_DEVIATION 2.23 • n=5 Participants
|
9.79 mmol/L
STANDARD_DEVIATION 2.36 • n=7 Participants
|
9.74 mmol/L
STANDARD_DEVIATION 2.29 • n=5 Participants
|
|
Diabetes History
|
9.58 years
STANDARD_DEVIATION 5.62 • n=5 Participants
|
9.90 years
STANDARD_DEVIATION 5.65 • n=7 Participants
|
9.74 years
STANDARD_DEVIATION 5.63 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: Sample size calculation: Assuming a standard deviation of 1.0 for HbA1c, 100 subjects in each treatment arm would be required to obtain a power of 80% for detecting a HbA1c difference of 0.4%. FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.
Outcome measures
| Measure |
Comb
n=103 Participants
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
n=106 Participants
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
HbA1c (Glycosylated Haemoglobin A1c)
|
7.08 Percent (%) glycosylated haemoglobin
Standard Error 0.09
|
7.64 Percent (%) glycosylated haemoglobin
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Week 26Population: FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.
Outcome measures
| Measure |
Comb
n=103 Participants
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
n=106 Participants
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%
Target achieved
|
46 Subjects
|
25 Subjects
|
|
Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%
Target not achieved
|
57 Subjects
|
81 Subjects
|
SECONDARY outcome
Timeframe: Week 26Population: FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.
Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia
Outcome measures
| Measure |
Comb
n=103 Participants
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
n=106 Participants
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia
Target achieved
|
37 Subjects
|
21 Subjects
|
|
Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia
Target not achieved
|
66 Subjects
|
85 Subjects
|
SECONDARY outcome
Timeframe: Week 26Population: FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.
Outcome measures
| Measure |
Comb
n=103 Participants
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
n=106 Participants
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%
Target achieved
|
20 Subjects
|
11 Subjects
|
|
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%
Target not achieved
|
83 Subjects
|
95 Subjects
|
SECONDARY outcome
Timeframe: Week 26Population: FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.
Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia
Outcome measures
| Measure |
Comb
n=103 Participants
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
n=106 Participants
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia
Target achieved
|
15 Subjects
|
8 Subjects
|
|
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia
Target not achieved
|
88 Subjects
|
98 Subjects
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.
Outcome measures
| Measure |
Comb
n=103 Participants
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
n=107 Participants
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
Change in BMI (Body Mass Index)
|
-0.30 kg/m^2
Standard Error 0.15
|
-0.58 kg/m^2
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.
Outcome measures
| Measure |
Comb
n=103 Participants
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
n=107 Participants
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
Change in Body Weight
|
-0.81 kg
Standard Error 0.44
|
-1.66 kg
Standard Error 0.42
|
SECONDARY outcome
Timeframe: Week 26Population: FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.
Outcome measures
| Measure |
Comb
n=103 Participants
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
n=106 Participants
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
FPG (Fasting Plasma Glucose)
|
6.08 mmol/L
Standard Error 0.24
|
8.52 mmol/L
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.
Overall: All episodes. Minor: Symptomatic, with PG \< 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L
Outcome measures
| Measure |
Comb
n=107 Participants
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
n=110 Participants
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
Hypoglycemic Episodes
Overall
|
1 episodes
|
1 episodes
|
|
Hypoglycemic Episodes
Minor
|
0 episodes
|
0 episodes
|
|
Hypoglycemic Episodes
Symptoms Only
|
0 episodes
|
0 episodes
|
|
Hypoglycemic Episodes
Unclassified
|
0 episodes
|
0 episodes
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.
Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG \< 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L
Outcome measures
| Measure |
Comb
n=107 Participants
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
n=110 Participants
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
Hypoglycemic Episodes: Day Time
Overall
|
1 episodes
|
1 episodes
|
|
Hypoglycemic Episodes: Day Time
Minor
|
0 episodes
|
0 episodes
|
|
Hypoglycemic Episodes: Day Time
Symptoms Only
|
0 episodes
|
0 episodes
|
|
Hypoglycemic Episodes: Day Time
Unclassified
|
0 episodes
|
0 episodes
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.
Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG \< 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L
Outcome measures
| Measure |
Comb
n=107 Participants
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
n=110 Participants
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
Hypoglycemic Episodes: Night Time
Overall
|
0 episodes
|
0 episodes
|
|
Hypoglycemic Episodes: Night Time
Minor
|
0 episodes
|
0 episodes
|
|
Hypoglycemic Episodes: Night Time
Symptoms Only
|
0 episodes
|
0 episodes
|
|
Hypoglycemic Episodes: Night Time
Unclassified
|
0 episodes
|
0 episodes
|
SECONDARY outcome
Timeframe: Week 26Population: FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.
Outcome measures
| Measure |
Comb
n=98 Participants
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
n=98 Participants
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
Self-measured 9-point Plasma Glucose Profile
Before breakfast the following day
|
6.07 mmol/L
Standard Error 0.19
|
7.87 mmol/L
Standard Error 0.19
|
|
Self-measured 9-point Plasma Glucose Profile
Before breakfast
|
6.16 mmol/L
Standard Error 0.20
|
8.17 mmol/L
Standard Error 0.20
|
|
Self-measured 9-point Plasma Glucose Profile
120 minutes after start of breakfast
|
8.82 mmol/L
Standard Error 0.28
|
10.50 mmol/L
Standard Error 0.28
|
|
Self-measured 9-point Plasma Glucose Profile
Before Lunch
|
6.99 mmol/L
Standard Error 0.26
|
8.01 mmol/L
Standard Error 0.26
|
|
Self-measured 9-point Plasma Glucose Profile
120 minutes after start of lunch
|
8.69 mmol/L
Standard Error 0.28
|
9.99 mmol/L
Standard Error 0.28
|
|
Self-measured 9-point Plasma Glucose Profile
Before dinner
|
7.85 mmol/L
Standard Error 0.31
|
8.61 mmol/L
Standard Error 0.31
|
|
Self-measured 9-point Plasma Glucose Profile
120 minutes after start of dinner
|
9.30 mmol/L
Standard Error 0.32
|
10.20 mmol/L
Standard Error 0.32
|
|
Self-measured 9-point Plasma Glucose Profile
Bedtime
|
8.38 mmol/L
Standard Error 0.32
|
9.42 mmol/L
Standard Error 0.31
|
|
Self-measured 9-point Plasma Glucose Profile
At 03:00 A.M.
|
6.85 mmol/L
Standard Error 0.26
|
8.02 mmol/L
Standard Error 0.26
|
Adverse Events
Comb
Serious events: 2 serious events
Other events: 76 other events
Deaths: 0 deaths
Sita
Serious events: 4 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Comb
n=107 participants at risk
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
n=110 participants at risk
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/107 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
0.91%
1/110 • Number of events 1 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/107 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
0.91%
1/110 • Number of events 1 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/107 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
0.91%
1/110 • Number of events 1 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/107 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
0.91%
1/110 • Number of events 1 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibromatosis
|
0.93%
1/107 • Number of events 1 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
0.00%
0/110 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.93%
1/107 • Number of events 1 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
0.00%
0/110 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
Other adverse events
| Measure |
Comb
n=107 participants at risk
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
|
Sita
n=110 participants at risk
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
13.2%
10/76 • Number of events 13 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
19.4%
14/72 • Number of events 16 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.2%
7/76 • Number of events 7 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
13.9%
10/72 • Number of events 12 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Blood and lymphatic system disorders
Influenza
|
10.5%
8/76 • Number of events 9 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
5.6%
4/72 • Number of events 4 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Blood and lymphatic system disorders
Bronchitis
|
5.3%
4/76 • Number of events 4 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
5.6%
4/72 • Number of events 4 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Gastrointestinal disorders
Nausea
|
6.6%
5/76 • Number of events 7 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
11.1%
8/72 • Number of events 20 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.6%
5/76 • Number of events 11 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
4.2%
3/72 • Number of events 11 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Nervous system disorders
Headache
|
14.5%
11/76 • Number of events 17 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
18.1%
13/72 • Number of events 32 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Nervous system disorders
Dizziness
|
3.9%
3/76 • Number of events 3 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
5.6%
4/72 • Number of events 21 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.9%
3/76 • Number of events 4 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
5.6%
4/72 • Number of events 4 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
8/76 • Number of events 9 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
2.8%
2/72 • Number of events 2 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.9%
3/76 • Number of events 4 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
6.9%
5/72 • Number of events 5 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
4/76 • Number of events 4 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
2.8%
2/72 • Number of events 2 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
General disorders
Fatigue
|
9.2%
7/76 • Number of events 8 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
1.4%
1/72 • Number of events 1 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
General disorders
Asthenia
|
0.00%
0/76 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
6.9%
5/72 • Number of events 12 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.9%
3/76 • Number of events 3 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
6.9%
5/72 • Number of events 5 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
2/76 • Number of events 2 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
15.3%
11/72 • Number of events 12 • Weeks 0-26
Safety Analysis Set is all participants treated with trial product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk reserves the right not to release data before passing specified milestones. This includes the right not to release interim results that may later be found to be incorrect. At the end of the trial, one or more manuscripts will be prepared in collaboration between Investigator(s) and Novo Nordisk. Novo Nordisk will not suppress or veto publications but will reserve the right to postpone publication and/or communication for a short time to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER