Trial Outcomes & Findings for Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes (NCT NCT01076647)
NCT ID: NCT01076647
Last Updated: 2017-03-06
Results Overview
Change from baseline in HbA1c after 26 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
467 participants
Primary outcome timeframe
Week 0, Week 26
Results posted on
2017-03-06
Participant Flow
The trial was conducted at 89 sites in 7 countries: Bulgaria, Canada, France, Hungary, Netherlands, Romania, and United States.
Participant milestones
| Measure |
IDeg 3TW
Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
|
IGlar OD
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
233
|
234
|
|
Overall Study
COMPLETED
|
208
|
209
|
|
Overall Study
NOT COMPLETED
|
25
|
25
|
Reasons for withdrawal
| Measure |
IDeg 3TW
Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
|
IGlar OD
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
7
|
9
|
|
Overall Study
Withdrawal criteria
|
2
|
2
|
|
Overall Study
Unclassified
|
12
|
12
|
Baseline Characteristics
Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
IDeg 3TW
n=233 Participants
Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
|
IGlar OD
n=234 Participants
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
|
Total
n=467 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
57.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Glycosylated haemoglobin (HbaA1c)
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.8 • 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
|
|
Body Weight
|
92.3 kg
STANDARD_DEVIATION 18.3 • n=5 Participants
|
91.4 kg
STANDARD_DEVIATION 18.7 • n=7 Participants
|
91.8 kg
STANDARD_DEVIATION 18.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 26Population: The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).
Change from baseline in HbA1c after 26 weeks of treatment
Outcome measures
| Measure |
IDeg 3TW
n=233 Participants
Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
|
IGlar OD
n=234 Participants
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
|
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c)
|
-1.05 percentage of glycosylated haemoglobin
Standard Deviation 0.94
|
-1.36 percentage of glycosylated haemoglobin
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: The FAS included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).
Change from baseline in body weight after 26 weeks of treatment
Outcome measures
| Measure |
IDeg 3TW
n=233 Participants
Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
|
IGlar OD
n=234 Participants
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
|
|---|---|---|
|
Change in Body Weight
|
0.8 kg
Standard Deviation 3.9
|
0.5 kg
Standard Deviation 3.7
|
Adverse Events
IDeg 3TW
Serious events: 13 serious events
Other events: 34 other events
Deaths: 0 deaths
IGlar OD
Serious events: 12 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDeg 3TW
n=233 participants at risk
Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
|
IGlar OD
n=234 participants at risk
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.43%
1/233 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/234 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/233 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.43%
1/234 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Cardiac disorders
Angina unstable
|
0.43%
1/233 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/234 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Cardiac disorders
Atrial fibrillation
|
0.43%
1/233 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.43%
1/234 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Cardiac disorders
Cardiac asthma
|
0.00%
0/233 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.43%
1/234 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Cardiac disorders
Tachycardia
|
0.43%
1/233 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/234 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/233 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.43%
1/234 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Gastrointestinal disorders
Periodontitis
|
0.43%
1/233 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/234 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
General disorders
Chest pain
|
0.00%
0/233 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.43%
1/234 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/233 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.85%
2/234 • Number of events 2 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.43%
1/233 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/234 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.43%
1/233 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/234 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Metabolism and nutrition disorders
Hyponatraemic syndrome
|
0.43%
1/233 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/234 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/233 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.43%
1/234 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/233 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.43%
1/234 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.43%
1/233 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/234 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.43%
1/233 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/234 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/233 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.43%
1/234 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/233 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.43%
1/234 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/233 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.43%
1/234 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Nervous system disorders
Vertigo CNS origin
|
0.43%
1/233 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/234 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Psychiatric disorders
Depression
|
0.00%
0/233 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.43%
1/234 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/233 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.43%
1/234 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/233 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.43%
1/234 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.43%
1/233 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/234 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Surgical and medical procedures
Lithotripsy
|
0.43%
1/233 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/234 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/233 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.43%
1/234 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Vascular disorders
Deep vein thrombosis
|
0.43%
1/233 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/234 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Vascular disorders
Hypotension
|
0.00%
0/233 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
0.43%
1/234 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
Other adverse events
| Measure |
IDeg 3TW
n=233 participants at risk
Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
|
IGlar OD
n=234 participants at risk
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
11/233 • Number of events 13 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
5.6%
13/234 • Number of events 16 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
13/233 • Number of events 14 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
2.6%
6/234 • Number of events 6 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
|
Nervous system disorders
Headache
|
6.0%
14/233 • Number of events 18 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
3.4%
8/234 • Number of events 9 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk maintains the right to be informed of any Investigator plans for publication 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 prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
- Publication restrictions are in place
Restriction type: OTHER