Trial Outcomes & Findings for Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes (NCT NCT01059799)
NCT ID: NCT01059799
Last Updated: 2017-03-30
Results Overview
Change from baseline in HbA1c after 26 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
435 participants
Primary outcome timeframe
Week 0, Week 26
Results posted on
2017-03-30
Participant Flow
The trial was conducted at 52 sites in 6 countries: Hong Kong (1), Japan (12), Malaysia (8), South Korea (19), Thailand (6) and Taiwan (6)
Subjects continued on their current treatment with oral antidiabetic drug(s) (OAD(s) treatment except for dipeptyl peptidase-4 (DPP-4) inhibitors, at the pre-randomisation dose level and dosing frequency.
Participant milestones
| Measure |
IDeg OD
Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
IGlar OD
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Overall Study
STARTED
|
289
|
146
|
|
Overall Study
Exposed
|
284
|
146
|
|
Overall Study
COMPLETED
|
258
|
136
|
|
Overall Study
NOT COMPLETED
|
31
|
10
|
Reasons for withdrawal
| Measure |
IDeg OD
Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
IGlar OD
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Withdrawal criteria
|
13
|
2
|
|
Overall Study
Other
|
12
|
3
|
Baseline Characteristics
Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
IDeg OD
n=289 Participants
Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
IGlar OD
n=146 Participants
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
Total
n=435 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
58.6 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
158 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
8.4 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.8 • n=5 Participants
|
8.5 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.8 • n=7 Participants
|
8.5 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Fasting plasma glucose (FPG)
|
8.4 mmol/L
STANDARD_DEVIATION 2.1 • n=5 Participants
|
8.6 mmol/L
STANDARD_DEVIATION 1.9 • n=7 Participants
|
8.5 mmol/L
STANDARD_DEVIATION 2.0 • 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 OD
n=289 Participants
Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
IGlar OD
n=146 Participants
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c)
|
-1.24 percentage of glycosylated haemoglobin
Standard Deviation 0.87
|
-1.35 percentage of glycosylated haemoglobin
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Week 0 to Week 26 + 7 days follow upPopulation: The Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Outcome measures
| Measure |
IDeg OD
n=284 Participants
Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
IGlar OD
n=146 Participants
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Rate of Confirmed Hypoglycaemic Episodes
|
298 Episodes/100 years of patient exposure
|
370 Episodes/100 years of patient exposure
|
SECONDARY outcome
Timeframe: Week 0 to Week 26 + 7 days follow upPopulation: The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Outcome measures
| Measure |
IDeg OD
n=284 Participants
Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
IGlar OD
n=146 Participants
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
|
78 Episodes/100 years of patient exposure
|
124 Episodes/100 years of patient exposure
|
SECONDARY outcome
Timeframe: Week 26Population: The FAS included all randomised subjects.The missing data is imputed using last observation carried forward (LOCF). For 25 subjects all 9-point SMPG values were missing.
Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast.
Outcome measures
| Measure |
IDeg OD
n=270 Participants
Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
IGlar OD
n=140 Participants
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
|
8.2 mmol/L
Standard Deviation 1.8
|
8.0 mmol/L
Standard Deviation 1.9
|
Adverse Events
IDeg OD
Serious events: 8 serious events
Other events: 58 other events
Deaths: 0 deaths
IGlar OD
Serious events: 8 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDeg OD
n=284 participants at risk
Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
IGlar OD
n=146 participants at risk
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.35%
1/284 • 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%
0/146 • 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 failure congestive
|
0.00%
0/284 • 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.
|
0.68%
1/146 • 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
Coronary artery disease
|
0.00%
0/284 • 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.
|
0.68%
1/146 • 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
Coronary artery occlusion
|
0.35%
1/284 • 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%
0/146 • 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
Colonic polyp
|
0.00%
0/284 • 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.
|
0.68%
1/146 • 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.
|
|
General disorders
Drowning
|
0.35%
1/284 • 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%
0/146 • 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
Diverticulitis
|
0.35%
1/284 • 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%
0/146 • 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
Cataract operation complication
|
0.35%
1/284 • 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%
0/146 • 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
Muscle strain
|
0.00%
0/284 • 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.
|
0.68%
1/146 • 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
Rib fracture
|
0.35%
1/284 • 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%
0/146 • 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
|
0.00%
0/284 • 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.
|
0.68%
1/146 • 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
Hypoglycaemia
|
0.00%
0/284 • 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.
|
0.68%
1/146 • 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)
Breast cancer
|
0.00%
0/284 • 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.
|
0.68%
1/146 • 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)
Endometrial cancer
|
0.00%
0/284 • 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.
|
0.68%
1/146 • 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)
Large intestine carcinoma
|
0.35%
1/284 • 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%
0/146 • 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
Cerebrovascular accident
|
0.35%
1/284 • 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%
0/146 • 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
Pneumothorax
|
0.35%
1/284 • 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%
0/146 • 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
Ureteric calculus removal
|
0.35%
1/284 • 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%
0/146 • 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 OD
n=284 participants at risk
Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
IGlar OD
n=146 participants at risk
Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
|
|---|---|---|
|
Eye disorders
Diabetic retinopathy
|
5.3%
15/284 • 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.
|
4.1%
6/146 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
9.2%
26/284 • Number of events 32 • 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.
|
13.7%
20/146 • Number of events 26 • 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
|
7.7%
22/284 • Number of events 29 • 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.
|
11.0%
16/146 • Number of events 21 • 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