A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01569841
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy of insulin decludec with insulin glargine on glycaemic control using continuous glucose monitoring in patients with type 1 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 1	Drug: insulin degludec; Drug: insulin glargine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDeg	Drug: insulin degludec; Administered subcutaneously (s.c., under the skin) once daily.
Active Comparator: IGlar	Drug: insulin glargine; Administered subcutaneously (s.c., under the skin) once daily.

Outcome Measures

Primary Outcome Measures

1. Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL) [CGM occured during the last 2 weeks of the 6 weeks treatment period.]

   Time within the glycaemic target range [> 70 mg/dL (3.9 mmol/L) and < 130 mg/dL (7.2 mmol/L)] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period.

Secondary Outcome Measures

1. Mean Interstitial Glucose (IG) Based on 14 Days of CGM [CGM monitoring occurred during the last 2 weeks of the 6-week treatment period.]

   The observed mean of IG profile was obtained as the average value of area under the IG profile divided by the actual assessment time interval during the last 2 weeks of the 6-week treatment period.

2. Fasting Plasma Glucose (FPG) [At the end of each 6 week treatment period.]

   FPG after 6 weeks of treatment in each treatment period.

3. Glycosylated Haemoglobin (HbA1c) [At the end of each 6 week treatment period.]

   HbA1c after 6 weeks of treatment in each treatment period.

4. Number of Treatment Emergent Adverse Events (AEs) [Within each week 6 treatment period]

   Number of treatment emergent adverse events (TEAEs). An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.

5. Number of Treatment Emergent Confirmed Hypoglycaemic Episodes [Hypoglycemic episodes reported within each 6 week treatment period.]

   A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product (IMP), and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type 1 diabetes

• HbA1c (glycosylated haemoglobin) below or equal to 8.5%

• Current treatment with IGlar (insulin glargine) in a basal-bolus regimen with a total daily dose below 120 U

• BMI (body mass index) below 35 kg/m^2

Exclusion Criteria:

• Use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucose lowering drug other than insulin/insulin analogues

• Subjects with regular use of acetaminophen who are not willing to use another analgetic during CGM (Continuous Glucose Monitoring) periods

• Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty within 24 weeks prior to visit 1

• Recurrent severe hypoglycemia (more than one severe hypoglycemic event during the last 12 months) or hypoglycemia unawareness or hospitalization for diabetic ketoacidosis during the previous 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Clinical Trial Call Center	Minneapolis	Minnesota	United States	55416-2699

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01569841
• Other Study ID Numbers: NN1250-3874; U1111-1125-7495
• First Posted: Apr 3, 2012
• Last Update Posted: Feb 18, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin; Insulin, Globin Zinc; Insulin Glargine

Study Results

Participant Flow

Recruitment Details	The trial was conducted at one site in the United States of America (USA).
Pre-assignment Detail	All subjects were on basal-bolus insulin regimens at screening using insulin glargine (IGlar) and either insulin aspart (IAsp) or insulin lispro (ILis). During the run-in period, IGlar 100 U/mL was administered subcutaneously (under the skin) once daily (OD) in the morning (before breakfast) along with IAsp 100 U/mL as meal-time insulin.

Arm/Group Title	IDeg/IGlar	IGlar/IDeg
Arm/Group Description	The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B. Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks.	The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B. Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks.
Period Title: Period A (6 Weeks)
STARTED	12	12
Exposed	12	12
COMPLETED	12	11
NOT COMPLETED	0	1
Period Title: Period A (6 Weeks)
STARTED	12	11
Exposed	12	11
COMPLETED	12	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Full Analysis Set
Arm/Group Description	The full analysis set (FAS) included all randomised subjects.
Overall Participants	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.3 (14.9)
Sex: Female, Male (Count of Participants)
Female	9 37.5%
Male	15 62.5%
Fasting Plasma Glucose (FPG) (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]	10.7 (3.4)
Glycosylated Haemoglobin (HbA1c) (percentage of glycosylated haemoglobin) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of glycosylated haemoglobin]	7.1 (0.6)

Outcome Measures

1. Primary Outcome

Title	Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)
Description	Time within the glycaemic target range [> 70 mg/dL (3.9 mmol/L) and < 130 mg/dL (7.2 mmol/L)] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period.
Time Frame	CGM occured during the last 2 weeks of the 6 weeks treatment period.

Outcome Measure Data

Analysis Population Description

The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.

Arm/Group Title	IDeg	IGlar
Arm/Group Description	The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks. Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks.	The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks. Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.
Measure Participants	23	23
Mean (Standard Deviation) [hours]	1.39 (0.71)	1.09 (0.77)

2. Secondary Outcome

Title	Mean Interstitial Glucose (IG) Based on 14 Days of CGM
Description	The observed mean of IG profile was obtained as the average value of area under the IG profile divided by the actual assessment time interval during the last 2 weeks of the 6-week treatment period.
Time Frame	CGM monitoring occurred during the last 2 weeks of the 6-week treatment period.

Outcome Measure Data

Analysis Population Description

The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.

Arm/Group Title	IDeg	IGlar
Arm/Group Description	The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks. Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks.	The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks. Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.
Measure Participants	23	23
Mean (Standard Deviation) [mmol/L]	9.6 (1.5)	9.8 (1.7)

3. Secondary Outcome

Title	Fasting Plasma Glucose (FPG)
Description	FPG after 6 weeks of treatment in each treatment period.
Time Frame	At the end of each 6 week treatment period.

Outcome Measure Data

Analysis Population Description

The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.

Arm/Group Title	IDeg/IGlar	IGlar/IDeg
Arm/Group Description	The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B. Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks.	The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B. Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks.
Measure Participants	12	11
Treatment period A	8.8 (4.6)	10.9 (4.8)
Treatment period B	10.4 (3.4)	10.9 (4.4)

4. Secondary Outcome

Title	Glycosylated Haemoglobin (HbA1c)
Description	HbA1c after 6 weeks of treatment in each treatment period.
Time Frame	At the end of each 6 week treatment period.

Outcome Measure Data

Analysis Population Description

The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.

Arm/Group Title	IDeg/IGlar	IGlar/IDeg
Arm/Group Description	The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B. Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks.	The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B. Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks.
Measure Participants	12	11
Treatment period A	6.6 (0.5)	7.1 (0.6)
Treatment period B	6.9 (0.7)	7.3 (0.6)

5. Secondary Outcome

Title	Number of Treatment Emergent Adverse Events (AEs)
Description	Number of treatment emergent adverse events (TEAEs). An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.
Time Frame	Within each week 6 treatment period

Outcome Measure Data

Analysis Population Description

The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.

Arm/Group Title	IDeg	IGlar
Arm/Group Description	The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks. Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks.	The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks. Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.
Measure Participants	23	24
Adverse Events	18	16
Serious Adverse Events	0	0
Severe Adverse Events	3	0
Moderate Adverse Events	5	0
Mild Adverse Events	10	16
Fatal Adverse Events	0	0

6. Secondary Outcome

Title	Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
Description	A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product (IMP), and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time Frame	Hypoglycemic episodes reported within each 6 week treatment period.

Outcome Measure Data

Analysis Population Description

The SAS included all subjects who received at least one dose of the investigational product or its comparator.

Arm/Group Title	IDeg	IGlar
Arm/Group Description	The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks. Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks.	The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks. Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.
Measure Participants	23	24
Number [events]	283	239

Adverse Events

Time Frame	Treatment emergent adverse events were collected during each 6 week treatment period + 7 days follow up.
Adverse Event Reporting Description	The SAS included all subjects who received at least one dose of the investigational product or its comparator.
Arm/Group Title	IDeg		IGlar
Arm/Group Description	The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks. Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks.		The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks. Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks. Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.
All Cause Mortality
	IDeg		IGlar
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	IDeg		IGlar
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	IDeg		IGlar
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		8/24 (33.3%)
Infections and infestations
Nasopharyngitis	0/23 (0%)	0	8/24 (33.3%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Novo Nordisk maintains the right to be informed of plans by any investigator to publish 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 Novo Nordisk before submission for comments. Comments will be given within four weeks from receipt of the planned communication.