Trial Outcomes & Findings for Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin (NCT NCT01046110)

NCT ID: NCT01046110

Last Updated: 2017-03-03

Results Overview

Change from baseline in HbA1c after 26 weeks of treatment

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 458 participants
• Primary outcome timeframe: Week 0, Week 26
• Results posted on: 2017-03-03

Participant Flow

The trial was conducted at 78 sites in 7 countries: Argentina (2 sites), Canada (11 sites), India (8 sites), Mexico (2 sites), South Africa (3 sites), Turkey (5 sites) and the United States (47 sites).

Participant milestones

Measure	IDeg OD Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).	DPP-IV Inhibitor Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
Overall Study STARTED	229	229
Overall Study Exposed	226	228
Overall Study COMPLETED	174	174
Overall Study NOT COMPLETED	55	55

Reasons for withdrawal

Measure	IDeg OD Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).	DPP-IV Inhibitor Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
Overall Study Adverse Event	9	2
Overall Study Lack of Efficacy	0	1
Overall Study Protocol Violation	7	12
Overall Study Withdrawal Criteria	3	5
Overall Study Unclassified	36	35

Baseline Characteristics

Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin

Baseline characteristics by cohort

Measure	IDeg OD n=225 Participants Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).	DPP-IV Inhibitor n=222 Participants Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.	Total n=447 Participants Total of all reporting groups
Age, Continuous	56.4 years STANDARD_DEVIATION 10.2 • n=5 Participants	54.9 years STANDARD_DEVIATION 11.4 • n=7 Participants	55.7 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	101 Participants n=7 Participants	185 Participants n=5 Participants
Sex: Female, Male Male	141 Participants n=5 Participants	121 Participants n=7 Participants	262 Participants n=5 Participants
Glycosylated haemoglobin (HbA1c)	8.8 percentage of glycosylated haemoglobin STANDARD_DEVIATION 1.0 • n=5 Participants	9.0 percentage of glycosylated haemoglobin STANDARD_DEVIATION 1.0 • n=7 Participants	8.9 percentage of glycosylated haemoglobin STANDARD_DEVIATION 1.0 • n=5 Participants
Fasting plasma glucose (FPG)	9.4 mmol/L STANDARD_DEVIATION 2.6 • n=5 Participants	9.9 mmol/L STANDARD_DEVIATION 3.1 • n=7 Participants	9.7 mmol/L STANDARD_DEVIATION 2.9 • n=5 Participants

PRIMARY outcome

Timeframe: Week 0, Week 26

Population: The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). A site was closed, hence 11 randomised subjects (4 subjects with IDeg; 7 subjects with DPP-IV group/arm) were excluded from the FAS.

Change from baseline in HbA1c after 26 weeks of treatment

Outcome measures

Measure	IDeg OD n=225 Participants Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).	DPP-IV Inhibitor n=222 Participants Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
Change in Glycosylated Haemoglobin (HbA1c)	-1.56 percentage of glycosylated haemoglobin Standard Deviation 1.09	-1.22 percentage of glycosylated haemoglobin Standard Deviation 1.16

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: The FAS included all randomised subjects and missing data was imputed using LOCF. One site was closed, hence 11 randomised subjects (4 in IDeg and 7 in DPP-IV group/arm) were excluded from the FAS. Fasting plasma glucose values were missing for another 8 subjects, hence did not contribute to the analysis.

Change from baseline in FPG after 26 weeks of treatment

Outcome measures

Measure	IDeg OD n=221 Participants Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).	DPP-IV Inhibitor n=218 Participants Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
Change in Fasting Plasma Glucose (FPG)	-3.22 mmol/L Standard Deviation 3.17	-1.39 mmol/L Standard Deviation 3.11

Adverse Events

IDeg OD

Serious events: 14 serious events

Other events: 44 other events

Deaths: 0 deaths

DPP-IV Inhibitor

Serious events: 10 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Measure	IDeg OD n=226 participants at risk Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).	DPP-IV Inhibitor n=228 participants at risk Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
Cardiac disorders Acute coronary syndrome	0.00% 0/226 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Cardiac disorders Acute myocardial infarction	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Cardiac disorders Cardiac failure congestive	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Cardiac disorders Cardiomyopathy	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Cardiac disorders Myocardial infarction	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Cardiac disorders Myocardial ischaemia	0.00% 0/226 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Gastrointestinal disorders Constipation	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Gastrointestinal disorders Food poisoning	0.00% 0/226 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Hepatobiliary disorders Cholelithiasis	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Infections and infestations Cellulitis	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Infections and infestations Diverticulitis	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Infections and infestations Lobar pneumonia	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Infections and infestations Pneumonia	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Injury, poisoning and procedural complications Accident	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Injury, poisoning and procedural complications Hip fracture	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Injury, poisoning and procedural complications Traumatic brain injury	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/226 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/226 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/226 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/226 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Nervous system disorders Cerebrovascular accident	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Nervous system disorders Transient ischaemic attack	0.00% 0/226 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Renal and urinary disorders Urinary retention	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Reproductive system and breast disorders Fallopian tube cyst	0.00% 0/226 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Vascular disorders Peripheral ischaemia	0.44% 1/226 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included 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 The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.

Other adverse events

Measure	IDeg OD n=226 participants at risk Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).	DPP-IV Inhibitor n=228 participants at risk Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
Gastrointestinal disorders Diarrhoea	5.8% 13/226 • Number of events 29 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.	8.3% 19/228 • Number of events 27 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Gastrointestinal disorders Nausea	3.5% 8/226 • Number of events 8 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.	6.1% 14/228 • Number of events 14 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Infections and infestations Nasopharyngitis	5.8% 13/226 • Number of events 14 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.	7.9% 18/228 • Number of events 22 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Nervous system disorders Headache	10.6% 24/226 • Number of events 38 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.	6.6% 15/228 • Number of events 24 • The adverse events were collected in a time frame of 26 weeks + 7 days follow-up The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.

Additional Information

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