Trial Outcomes & Findings for A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (NCT NCT01849289)
NCT ID: NCT01849289
Last Updated: 2017-04-07
Results Overview
Change from baseline in HbA1c (%) after 26 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
833 participants
Primary outcome timeframe
Week 0, week 26
Results posted on
2017-04-07
Participant Flow
The trial was conducted at 68 sites in six countries as follows: Brazil: 3 sites; Canada: 7 sites; China: 37 sites; South Africa: 4 sites; Ukraine: 6 sites; United States: 11 sites.
The subjects discontinued their current Oral Antidiabetic drug (OAD) treatment at Visit 2 (randomisation visit) except for metformin, before starting the treatment with trial drugs.
Participant milestones
| Measure |
IDeg OD
Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
IGlar OD
Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
|---|---|---|
|
Overall Study
STARTED
|
555
|
278
|
|
Overall Study
Exposed
|
553
|
278
|
|
Overall Study
COMPLETED
|
523
|
254
|
|
Overall Study
NOT COMPLETED
|
32
|
24
|
Reasons for withdrawal
| Measure |
IDeg OD
Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
IGlar OD
Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Protocol Violation
|
3
|
3
|
|
Overall Study
Withdrawal criteria
|
1
|
0
|
|
Overall Study
Unclassified
|
25
|
18
|
Baseline Characteristics
A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
IDeg OD
n=555 Participants
Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
IGlar OD
n=278 Participants
Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
Total
n=833 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
256 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
402 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
299 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
431 Participants
n=5 Participants
|
|
HbA1c
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=5 Participants
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.8 • n=7 Participants
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Fasting Plasma Glucose (FPG)
|
9.4 mmol/L
STANDARD_DEVIATION 2.4 • n=5 Participants
|
9.4 mmol/L
STANDARD_DEVIATION 2.5 • n=7 Participants
|
9.4 mmol/L
STANDARD_DEVIATION 2.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 26Population: The FAS included all randomised subjects. Last Observation Carried Forward (LOCF) values were presented for this endpoint.
Change from baseline in HbA1c (%) after 26 weeks of treatment.
Outcome measures
| Measure |
IDeg OD
n=555 Participants
Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
IGlar OD
n=278 Participants
Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
|---|---|---|
|
Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)
|
-1.3 percentage of glycosylated haemoglobin
Standard Deviation 1.1
|
-1.2 percentage of glycosylated haemoglobin
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)Population: The Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or its comparator.
Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed PG value of less than 3.1 mmol/L (56 mg/dL).Minor hypoglycaemic episode is defined as an episode with symptoms consistent with hypoglycaemia with confirmation by full blood glucose \< 2.8 mmol/L (50 mg/dL), or PG \< 3.1 mmol/L (56 mg/dL) and which is handled by the subject himself/herself or any asymptomatic full blood glucose value \< 2.8 mmol/L (50 mg/dL) or PG value \< 3.1 mmol/L (56 mg/dL).
Outcome measures
| Measure |
IDeg OD
n=553 Participants
Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
IGlar OD
n=278 Participants
Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
|---|---|---|
|
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
|
85 Episodes/100 years of patient exposure
|
97 Episodes/100 years of patient exposure
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: The FAS included all randomised subjects. LOCF values are presented for this endpoint. 7 subjects were not included in the analysis.
Change from baseline in FPG after 26 weeks of treatment.
Outcome measures
| Measure |
IDeg OD
n=549 Participants
Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
IGlar OD
n=277 Participants
Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
|---|---|---|
|
Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)
|
-3.35 mmol/L
Standard Deviation 2.91
|
-3.14 mmol/L
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: Week 26Population: The FAS included all randomised subjects. Missing data were imputed using LOCF. For 2 subjects in the IDeg OD arm it was not possible to estimate CV(%) due to missing data.
Within subject Coefficient of variation(CV\[%\]) in pre-breakfast self measured plasma glucose for dose adjustment after 26 treatment weeks are displayed below.
Outcome measures
| Measure |
IDeg OD
n=553 Participants
Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
IGlar OD
n=278 Participants
Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
|---|---|---|
|
Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)
|
10.65 percentage
Standard Deviation 9.15
|
10.01 percentage
Standard Deviation 7.95
|
SECONDARY outcome
Timeframe: Week 26Population: The FAS included all randomised subjects.
A responder for HbA1c without severe or confirmed hypoglycaemia is defined as a subject, who meets the HbA1c target at end of trial without treatment emergent severe or confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days from last treatment.
Outcome measures
| Measure |
IDeg OD
n=555 Participants
Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
IGlar OD
n=278 Participants
Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
|---|---|---|
|
Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes
|
252 participants
|
114 participants
|
SECONDARY outcome
Timeframe: On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)Population: The SAS included all subjects receiving at least one dose of investigational product.
Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Outcome measures
| Measure |
IDeg OD
n=553 Participants
Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
IGlar OD
n=278 Participants
Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
|---|---|---|
|
Number of Treatment Emergent AEs (Adverse Events)
|
612 number of events
|
387 number of events
|
Adverse Events
IDeg OD
Serious events: 16 serious events
Other events: 100 other events
Deaths: 0 deaths
IGlar OD
Serious events: 10 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDeg OD
n=553 participants at risk
Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
IGlar OD
n=278 participants at risk
Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
|---|---|---|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/553 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.36%
1/278 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.18%
1/553 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.00%
0/278 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/553 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.36%
1/278 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/553 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.36%
1/278 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.18%
1/553 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.00%
0/278 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.18%
1/553 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.00%
0/278 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.18%
1/553 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.00%
0/278 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Appendicitis
|
0.18%
1/553 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.36%
1/278 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Diverticulitis
|
0.18%
1/553 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.00%
0/278 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Gastroenteritis
|
0.18%
1/553 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.00%
0/278 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/553 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.36%
1/278 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/553 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.36%
1/278 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Pyelonephritis
|
0.18%
1/553 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.00%
0/278 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.18%
1/553 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.00%
0/278 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.18%
1/553 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.72%
2/278 • Number of events 2 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/553 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.36%
1/278 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.18%
1/553 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.00%
0/278 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.18%
1/553 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.00%
0/278 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/553 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.36%
1/278 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.18%
1/553 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.36%
1/278 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Nervous system disorders
Cerebral infarction
|
0.36%
2/553 • Number of events 2 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.36%
1/278 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
2/553 • Number of events 2 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.00%
0/278 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.18%
1/553 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
0.00%
0/278 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
Other adverse events
| Measure |
IDeg OD
n=553 participants at risk
Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
IGlar OD
n=278 participants at risk
Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.4%
41/553 • Number of events 49 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
9.7%
27/278 • Number of events 40 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.8%
60/553 • Number of events 77 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
11.5%
32/278 • Number of events 40 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety Analysis Set (SAS) included all subjects receiving at least one dose of investigational product.
|
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 Novo Nordisk 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