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Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen (Full STEP™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01165684
First received: July 16, 2010
Last updated: January 2, 2017
Last verified: January 2017
Results First Received: April 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: insulin aspart
Drug: insulin detemir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial was conducted at 69 sites in 7 countries: Argentina (7), Brazil (5), Canada (12), France (7), Macedonia (1), Slovenia (4), and the US (31). Of 12 sites in Canada, one site (Site 303) closed early on 07-Mar-2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects on pre-trial metformin and pioglitazone continued their medication.

Reporting Groups
  Description
Step-wise In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
Basal-bolus In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.

Participant Flow:   Overall Study
    Step-wise   Basal-bolus
STARTED   201   200 
Exposed   198 [1]   199 [2] 
COMPLETED   173   148 
NOT COMPLETED   28   52 
Adverse Event                1                1 
Lack of Efficacy                2                1 
Protocol Violation                7                15 
Withdrawal Criteria                2                13 
Unclassified                16                22 
[1] 3 subjects withdrew prior to exposure to trial drug
[2] 1 subject withdrew prior to exposure to trial drug



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Step-wise In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
Basal-bolus In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
Total Total of all reporting groups

Baseline Measures
   Step-wise   Basal-bolus   Total 
Overall Participants Analyzed 
[Units: Participants]
 201   200   401 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.0  (9.1)   59.6  (9.5)   59.8  (9.3) 
Gender 
[Units: Participants]
Count of Participants
     
Female      97  48.3%      101  50.5%      198  49.4% 
Male      104  51.7%      99  49.5%      203  50.6% 
Body weight 
[Units: Kg]
Mean (Standard Deviation)
 88.9  (18.7)   86.1  (15.2)   87.5  (17.1) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 31.5  (4.8)   30.7  (4.6)   31.1  (4.7) 
Glycosylated haemoglobin (HbA1c) 
[Units: Percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
 7.9  (0.6)   7.9  (0.6)   7.9  (0.6) 
Fasting plasma glucose (FPG) 
[Units: mmol/L]
Mean (Standard Deviation)
 7.0  (1.9)   6.9  (1.6)   6.9  (1.8) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32   [ Time Frame: Week 0, Week 32 ]

2.  Secondary:   Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10   [ Time Frame: Week 0, Week 10 ]

3.  Secondary:   Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21   [ Time Frame: Week 0, Week 21 ]

4.  Secondary:   Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10   [ Time Frame: Week 10 ]

5.  Secondary:   Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21   [ Time Frame: Week 21 ]

6.  Secondary:   Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32   [ Time Frame: Week 32 ]

7.  Secondary:   Fasting Plasma Glucose (FPG) at Week 10   [ Time Frame: Week 10 ]

8.  Secondary:   Fasting Plasma Glucose (FPG) at Week 21   [ Time Frame: Week 21 ]

9.  Secondary:   Fasting Plasma Glucose (FPG) at Week 32   [ Time Frame: Week 32 ]

10.  Secondary:   Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10   [ Time Frame: Week 10 ]

11.  Secondary:   Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 21   [ Time Frame: Week 21 ]

12.  Secondary:   Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 32   [ Time Frame: Week 32 ]

13.  Secondary:   Body Weight at Week 32   [ Time Frame: Week 32 ]

14.  Secondary:   Body Mass Index (BMI) at Week 32   [ Time Frame: Week 32 ]

15.  Secondary:   Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes)   [ Time Frame: Week 0 to Week 32 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
A higher proportion of subjects did not complete the trial in the basal-bolus arm (52 subjects, 26.0%) than in the step-wise arm (28 subjects, 13.9%).


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


Publications of Results:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01165684     History of Changes
Other Study ID Numbers: ANA-3786
2010-018974-19 ( EudraCT Number )
U1111-1116-0908 ( Other Identifier: WHO )
Study First Received: July 16, 2010
Results First Received: April 25, 2013
Last Updated: January 2, 2017