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Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens (BOOST™)

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ClinicalTrials.gov Identifier: NCT01365507
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : November 20, 2015
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Intervention Drug: insulin degludec/insulin aspart
Enrollment 276
Recruitment Details This trial was conducted at 38 sites in 6 countries: Malaysia, Mexico, South Korea, Thailand, Turkey and the United States (U.S.).
Pre-assignment Details Subjects continued their metformin monotherapy or metformin in any combination with 1 or 2 additional oral antidiabetic drugs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV inhibitors, α-glucosidase inhibitors, thiazolidinediones, all with unchanged dosing for at least 12 weeks prior to randomisation.
Arm/Group Title IDegAsp Simple IDegAsp Step Wise
Hide Arm/Group Description Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration. Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
Period Title: Overall Study
Started 136 140
Exposed 134 [1] 140
Completed 127 131
Not Completed 9 9
Reason Not Completed
Withdrawal Criteria             8             5
Unclassified             1             4
[1]
Two subjects withdrew before exposure to trial drug
Arm/Group Title IDegAsp Simple IDegAsp Step Wise Total
Hide Arm/Group Description Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration. Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration. Total of all reporting groups
Overall Number of Baseline Participants 136 140 276
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 136 participants 140 participants 276 participants
57.0  (9.4) 55.8  (9.7) 56.4  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 140 participants 276 participants
Female
59
  43.4%
84
  60.0%
143
  51.8%
Male
77
  56.6%
56
  40.0%
133
  48.2%
Glycosylated haemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of glycosylated haemoglobin
Number Analyzed 136 participants 140 participants 276 participants
8.3  (0.8) 8.2  (0.8) 8.3  (0.8)
Fasting plasma glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 136 participants 140 participants 276 participants
8.9  (2.4) 9.0  (2.3) 8.9  (2.4)
1.Primary Outcome
Title Change in Glycosylated Haemoglobin (HbA1c)
Hide Description Change from baseline in HbA1c after 26 weeks of treatment.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).
Arm/Group Title IDegAsp Simple IDegAsp Step Wise
Hide Arm/Group Description:
Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
Overall Number of Participants Analyzed 136 140
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated haemoglobin
-1.33  (1.03) -1.09  (0.82)
2.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG)
Hide Description Change from baseline in FPG after 26 weeks of treatment.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 2 subjects baseline values were missing, hence not included in the analysis.
Arm/Group Title IDegAsp Simple IDegAsp Step Wise
Hide Arm/Group Description:
Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
Overall Number of Participants Analyzed 135 139
Mean (Standard Deviation)
Unit of Measure: mmol/L
-2.99  (3.03) -2.73  (2.91)
3.Secondary Outcome
Title Rate of Treatment Emergent Adverse Events (AEs)
Hide Description Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Time Frame Week 0 to Week 26 + 7 days follow up
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who received at least one dose of the investigational product.
Arm/Group Title IDegAsp Simple IDegAsp Step Wise
Hide Arm/Group Description:
Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
Overall Number of Participants Analyzed 134 140
Measure Type: Number
Unit of Measure: Events/100 years of patient exposure
Adverse events (AEs) 226 342
Serious AEs 2 13
Severe AEs 3 3
Moderate AEs 68 112
Mild AEs 155 228
Fatal AEs 0 0
4.Secondary Outcome
Title Rate of Confirmed Hypoglycaemic Episodes
Hide Description Rate of 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 were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time Frame Week 0 to Week 26 + 7 days follow up
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who received at least one dose of the investigational product.
Arm/Group Title IDegAsp Simple IDegAsp Step Wise
Hide Arm/Group Description:
Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
Overall Number of Participants Analyzed 134 140
Measure Type: Number
Unit of Measure: Episodes/100 years of patient exposure
326 207
5.Secondary Outcome
Title Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Hide Description 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 were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.
Time Frame Week 0 to Week 26 + 7 days follow up
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who received at least one dose of the investigational product.
Arm/Group Title IDegAsp Simple IDegAsp Step Wise
Hide Arm/Group Description:
Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
Overall Number of Participants Analyzed 134 140
Measure Type: Number
Unit of Measure: Episodes/100 years of patient exposure
52 41
Time Frame The adverse events were collected in a time frame of 26 weeks + 7 days follow up.
Adverse Event Reporting Description The safety analysis set included all subjects who received at least one dose of the investigational product.
 
Arm/Group Title IDegAsp Simple IDegAsp Step Wise
Hide Arm/Group Description Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration. Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
All-Cause Mortality
IDegAsp Simple IDegAsp Step Wise
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IDegAsp Simple IDegAsp Step Wise
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/134 (0.75%)      6/140 (4.29%)    
Gastrointestinal disorders     
Diverticular perforation  1  1/134 (0.75%)  1 0/140 (0.00%)  0
Rectal haemorrhage  1  0/134 (0.00%)  0 1/140 (0.71%)  1
Hepatobiliary disorders     
Cholelithiasis  1  0/134 (0.00%)  0 1/140 (0.71%)  1
Infections and infestations     
Gastroenteritis  1  0/134 (0.00%)  0 1/140 (0.71%)  1
Injury, poisoning and procedural complications     
Facial bones fracture  1  0/134 (0.00%)  0 1/140 (0.71%)  1
Subcutaneous haematoma  1  0/134 (0.00%)  0 1/140 (0.71%)  1
Nervous system disorders     
Cerebral infarction  1  0/134 (0.00%)  0 1/140 (0.71%)  1
Convulsion  1  0/134 (0.00%)  0 1/140 (0.71%)  1
Dizziness postural  1  0/134 (0.00%)  0 1/140 (0.71%)  1
Thalamic infarction  1  0/134 (0.00%)  0 1/140 (0.71%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IDegAsp Simple IDegAsp Step Wise
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/134 (14.93%)      26/140 (18.57%)    
Infections and infestations     
Nasopharyngitis  1  8/134 (5.97%)  10 11/140 (7.86%)  13
Upper respiratory tract infection  1  12/134 (8.96%)  15 15/140 (10.71%)  18
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
EMail: clinicaltrials@novonordisk.com
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01365507     History of Changes
Other Study ID Numbers: NN5401-3844
U1111-1117-0558 ( Other Identifier: WHO )
First Submitted: May 31, 2011
First Posted: June 3, 2011
Results First Submitted: October 19, 2015
Results First Posted: November 20, 2015
Last Update Posted: March 17, 2017