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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: July 3, 2013
Last verified: July 2013
Results First Received: April 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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  
Number of Participants  
[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]
     
Female     97     101     198  
Male     104     99     203  
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


No publications provided by Novo Nordisk A/S

Publications automatically indexed to this study:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01165684     History of Changes
Other Study ID Numbers: ANA-3786, 2010-018974-19, U1111-1116-0908
Study First Received: July 16, 2010
Results First Received: April 25, 2013
Last Updated: July 3, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Brazil: National Health Surveillance Agency
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia
Slovenia: Agency of Drugs and Medicinal Products of the Slovenian Republic
United States: Food and Drug Administration