Trial Outcomes & Findings for Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes (NCT NCT01068665)
NCT ID: NCT01068665
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
460 participants
Primary outcome timeframe
Week 0, Week 26
Results posted on
2017-03-06
Participant Flow
The trial was conducted at 106 sites in 8 countries: Canada (11), France (6), Ireland (3), Russian Federation (7), South Africa (4), Ukraine (2), United Kingdom (18) and United States of America (55).
Subjects continued on metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitors at the pre-randomisation dose level and dosing frequency.
Participant milestones
| Measure |
IDeg 200 U/mL OD
Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
|
IGlar OD
Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
230
|
230
|
|
Overall Study
Full Analysis Set
|
228
|
229
|
|
Overall Study
Exposed
|
228
|
228
|
|
Overall Study
COMPLETED
|
200
|
201
|
|
Overall Study
NOT COMPLETED
|
30
|
29
|
Reasons for withdrawal
| Measure |
IDeg 200 U/mL OD
Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
|
IGlar OD
Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Protocol Violation
|
5
|
2
|
|
Overall Study
Withdrawal Criteria
|
3
|
9
|
|
Overall Study
Other
|
17
|
12
|
Baseline Characteristics
Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
IDeg 200 U/mL OD
n=228 Participants
Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
|
IGlar OD
n=229 Participants
Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
|
Total
n=457 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
57.5 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.0 • n=5 Participants
|
8.2 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=7 Participants
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Fasting plasma glucose (FPG)
|
9.6 mmol/L
STANDARD_DEVIATION 2.9 • n=5 Participants
|
9.7 mmol/L
STANDARD_DEVIATION 2.6 • n=7 Participants
|
9.6 mmol/L
STANDARD_DEVIATION 2.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 26Population: Full analysis set (FAS) includes all randomised subjects and missing data was imputed using last observation carried forward (LOCF). 2 subjects were withdrawn prior to exposure to the study drug in the IDeg arm as they were randomised in error and 1 subject in the IGlar arm.
Change from baseline in HbA1c after 26 weeks of treatment
Outcome measures
| Measure |
IDeg 200 U/mL OD
n=228 Participants
Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
|
IGlar OD
n=229 Participants
Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
|
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c)
|
-1.30 percentage of glycosylated haemoglobin
Standard Deviation 1.04
|
-1.32 percentage of glycosylated haemoglobin
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 3 subjects baseline values were missing.
Change from baseline in FPG after 26 weeks of treatment
Outcome measures
| Measure |
IDeg 200 U/mL OD
n=228 Participants
Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
|
IGlar OD
n=226 Participants
Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG)
|
-3.70 mmol/L
Standard Deviation 3.06
|
-3.38 mmol/L
Standard Deviation 2.96
|
Adverse Events
IDeg 200 U/mL OD
Serious events: 15 serious events
Other events: 51 other events
Deaths: 0 deaths
IGlar OD
Serious events: 10 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDeg 200 U/mL OD
n=228 participants at risk
Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
|
IGlar OD
n=228 participants at risk
Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/228 • 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.
|
0.44%
1/228 • 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
|
0.44%
1/228 • 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%
0/228 • 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
Coronary artery disease
|
0.88%
2/228 • 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.
|
0.00%
0/228 • 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
Myocardial infarction
|
0.44%
1/228 • 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%
0/228 • 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
Myocardial ischaemia
|
0.00%
0/228 • 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.
|
0.44%
1/228 • 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
Gastrooesophageal reflux disease
|
0.00%
0/228 • 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.
|
0.44%
1/228 • 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
Peritoneal haemorrhage
|
0.44%
1/228 • 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%
0/228 • 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
|
1.8%
4/228 • Number of events 4 • 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%
0/228 • 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
Polyp
|
0.44%
1/228 • 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%
0/228 • 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
Arthritis bacterial
|
0.44%
1/228 • 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%
0/228 • 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
Campylobacter infection
|
0.00%
0/228 • 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.
|
0.44%
1/228 • 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
Cellulitis
|
0.44%
1/228 • 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%
0/228 • 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
Herpes zoster
|
0.44%
1/228 • 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%
0/228 • 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
Localised infection
|
0.88%
2/228 • 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.
|
0.00%
0/228 • 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
Pneumonia
|
0.00%
0/228 • 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.
|
0.44%
1/228 • 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.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/228 • 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.
|
0.44%
1/228 • 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.
|
|
Injury, poisoning and procedural complications
Traumatic shock
|
0.44%
1/228 • 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%
0/228 • 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
Hypercalcaemia
|
0.00%
0/228 • 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.
|
0.44%
1/228 • 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.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/228 • 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.
|
0.44%
1/228 • 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 chest pain
|
0.00%
0/228 • 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.
|
0.44%
1/228 • 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
Osteoarthritis
|
0.88%
2/228 • 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.
|
0.00%
0/228 • 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)
Colon cancer
|
0.44%
1/228 • 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%
0/228 • 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)
Laryngeal cancer
|
0.44%
1/228 • 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%
0/228 • 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)
Lung neoplasm malignant
|
0.44%
1/228 • 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%
0/228 • 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)
Pancreatic carcinoma
|
0.00%
0/228 • 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.
|
0.44%
1/228 • 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
Ischaemic stroke
|
0.00%
0/228 • 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.
|
0.44%
1/228 • 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
Anxiety
|
0.44%
1/228 • 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%
0/228 • 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.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/228 • 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.
|
0.44%
1/228 • 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.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/228 • 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.
|
0.44%
1/228 • 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
Epistaxis
|
0.00%
0/228 • 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.
|
0.44%
1/228 • 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
|
0.44%
1/228 • 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%
0/228 • 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 200 U/mL OD
n=228 participants at risk
Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
|
IGlar OD
n=228 participants at risk
Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
17/228 • Number of events 24 • 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.
|
8.3%
19/228 • Number of events 22 • 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
|
7.5%
17/228 • 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.
|
5.3%
12/228 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
7/228 • Number of events 7 • 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.
|
6.6%
15/228 • 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.
|
|
Nervous system disorders
Headache
|
8.8%
20/228 • Number of events 27 • 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.
|
10.5%
24/228 • Number of events 36 • 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