Trial Outcomes & Findings for Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes (NCT NCT01068678)

NCT ID: NCT01068678

Last Updated: 2017-03-06

Results Overview

Change from baseline in HbA1c after week 26

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

460 participants

Primary outcome timeframe

Week 26

Results posted on

2017-03-06

Participant Flow

The trial was conducted at 94 sites in 7 countries: Canada (14 sites), Czech Republic (5 sites), Israel (5 sites), Slovakia (5 sites), South Africa (3 sites), United Kingdom (8 sites) and United States (54 sites). In addition, 9 sites (United Kingdom (1 site) and United States (8 sites)) were approved, but did not enroll any subjects.

Participant milestones

Participant milestones
Measure	IDeg 3TW Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.	IGlar OD Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
Overall Study STARTED	230	230
Overall Study Exposed	227	229
Overall Study COMPLETED	192	206
Overall Study NOT COMPLETED	38	24

Reasons for withdrawal

Reasons for withdrawal
Measure	IDeg 3TW Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.	IGlar OD Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
Overall Study Lack of Efficacy	3	2
Overall Study Protocol Violation	5	1
Overall Study Withdrawal criteria	12	6
Overall Study Unclassified	18	15

Baseline Characteristics

Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IDeg 3TW n=229 Participants Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.	IGlar OD n=230 Participants Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.	Total n=459 Participants Total of all reporting groups
Age, Continuous	58.4 years STANDARD_DEVIATION 9.9 • n=5 Participants	57.9 years STANDARD_DEVIATION 9.7 • n=7 Participants	58.1 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	93 Participants n=7 Participants	198 Participants n=5 Participants
Sex: Female, Male Male	124 Participants n=5 Participants	137 Participants n=7 Participants	261 Participants n=5 Participants
Glycosylated haemoglobin (HbA1c)	8.2 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.8 • n=5 Participants	8.3 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.9 • n=7 Participants	8.2 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.8 • n=5 Participants
Body weight	90.8 kg STANDARD_DEVIATION 18.6 • n=5 Participants	95.7 kg STANDARD_DEVIATION 19.0 • n=7 Participants	93.3 kg STANDARD_DEVIATION 18.9 • n=5 Participants
Fasting Plasma Glucose	9.3 mmol/L STANDARD_DEVIATION 2.4 • n=5 Participants	9.6 mmol/L STANDARD_DEVIATION 2.4 • n=7 Participants	9.5 mmol/L STANDARD_DEVIATION 2.4 • n=5 Participants

PRIMARY outcome

Timeframe: Week 26

Population: The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).1 subject was randomised despite being a screening failure.

Change from baseline in HbA1c after week 26

Outcome measures

Outcome measures
Measure	IDeg 3TW n=229 Participants Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.	IGlar OD n=230 Participants Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
Change in Glycosylated Haemoglobin (HbA1c)	-1.00 percentage of glycosylated haemoglobin Standard Deviation 0.95	-1.40 percentage of glycosylated haemoglobin Standard Deviation 1.07

SECONDARY outcome

Timeframe: Week 26

Population: The Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF). For 3 subjects baseline values were missing.

Change from baseline in body weight after week 26

Outcome measures

Outcome measures
Measure	IDeg 3TW n=227 Participants Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.	IGlar OD n=229 Participants Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
Change in Body Weight	0.8 kg Standard Deviation 3.6	1.0 kg Standard Deviation 3.7

Adverse Events

IDeg 3TW

Serious events: 11 serious events

Other events: 69 other events

Deaths: 0 deaths

IGlar OD

Serious events: 4 serious events

Other events: 77 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	IDeg 3TW n=227 participants at risk Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.	IGlar OD n=229 participants at risk Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
Gastrointestinal disorders Diarrhoea	7.0% 16/227 • Number of events 17 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	7.4% 17/229 • Number of events 20 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Gastrointestinal disorders Nausea	5.3% 12/227 • Number of events 12 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	6.6% 15/229 • Number of events 16 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
General disorders Injection site haematoma	4.8% 11/227 • Number of events 15 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	5.2% 12/229 • Number of events 12 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Infections and infestations Nasopharyngitis	6.6% 15/227 • Number of events 16 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	7.4% 17/229 • Number of events 18 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Infections and infestations Upper respiratory tract infection	2.2% 5/227 • Number of events 5 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	7.0% 16/229 • Number of events 19 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Musculoskeletal and connective tissue disorders Back pain	6.2% 14/227 • Number of events 18 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	6.1% 14/229 • Number of events 21 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Nervous system disorders Headache	11.5% 26/227 • Number of events 38 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	9.2% 21/229 • Number of events 26 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.

Additional Information

Public Access to Clinical Trials

Novo Nordisk A/S

Email: [email protected]

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

Measure	IDeg 3TW n=227 participants at risk Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.	IGlar OD n=229 participants at risk Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
Cardiac disorders Angina unstable	0.88% 2/227 • Number of events 2 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	0.00% 0/229 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Gastrointestinal disorders Abdominal pain	0.00% 0/227 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	0.44% 1/229 • Number of events 1 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
General disorders Non-cardiac chest pain	0.44% 1/227 • Number of events 1 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	0.00% 0/229 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Infections and infestations Appendicitis	0.44% 1/227 • Number of events 1 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	0.00% 0/229 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Infections and infestations Cellulitis	0.44% 1/227 • Number of events 1 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	0.00% 0/229 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Infections and infestations Diverticulitis	0.00% 0/227 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	0.44% 1/229 • Number of events 1 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Injury, poisoning and procedural complications Ankle fracture	0.44% 1/227 • Number of events 1 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	0.00% 0/229 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Injury, poisoning and procedural complications Forearm fracture	0.44% 1/227 • Number of events 1 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	0.00% 0/229 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Injury, poisoning and procedural complications Incisional hernia	0.44% 1/227 • Number of events 1 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	0.00% 0/229 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Metabolism and nutrition disorders Hypoglycaemia	0.44% 1/227 • Number of events 1 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	0.00% 0/229 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/227 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	0.44% 1/229 • Number of events 1 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/227 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	0.44% 1/229 • Number of events 1 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Renal and urinary disorders Calculus bladder	0.44% 1/227 • Number of events 1 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	0.00% 0/229 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Renal and urinary disorders Renal colic	0.00% 0/227 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	0.44% 1/229 • Number of events 1 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.
Vascular disorders Peripheral arterial occlusive disease	0.44% 1/227 • Number of events 2 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.	0.00% 0/229 • Adverse events were collected in a time frame of 26 weeks + 7 days follow up The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis.