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Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01046110
First received: January 8, 2010
Last updated: November 19, 2015
Last verified: November 2015
Results First Received: October 19, 2015  
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 degludec
Drug: sitagliptin

  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 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).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    IDeg OD   DPP-IV Inhibitor
STARTED   229   229 
Exposed   226 [1]   228 [2] 
COMPLETED   174   174 
NOT COMPLETED   55   55 
Adverse Event                9                2 
Lack of Efficacy                0                1 
Protocol Violation                7                12 
Withdrawal Criteria                3                5 
Unclassified                36                35 
[1] 2 subjects were randomised in error and 1 subject did not want to take insulin
[2] 1 subject was randomised in error



  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.
The full analysis set (FAS) included all randomised patients except for 11 subjects whose site was closed (4 subjects with IDeg; 7 subjects with DPP-IV group/arm). For 4 subjects each in IDeg OD and DPP-IV inhibitor arm, the fasting plasma glucose (FPG) values were missing at baseline.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   IDeg OD   DPP-IV Inhibitor   Total 
Overall Participants Analyzed 
[Units: Participants]
 225   222   447 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.4  (10.2)   54.9  (11.4)   55.7  (10.9) 
Gender 
[Units: Participants]
     
Female   84   101   185 
Male   141   121   262 
Glycosylated haemoglobin (HbA1c) 
[Units: Percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
 8.8  (1.0)   9.0  (1.0)   8.9  (1.0) 
Fasting plasma glucose (FPG) 
[Units: mmol/L]
Mean (Standard Deviation)
 9.4  (2.6)   9.9  (3.1)   9.7  (2.9) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Glycosylated Haemoglobin (HbA1c)   [ Time Frame: Week 0, Week 26 ]

2.  Secondary:   Change in Fasting Plasma Glucose (FPG)   [ Time Frame: Week 0, Week 26 ]


  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
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  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



Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01046110     History of Changes
Other Study ID Numbers: NN1250-3580
U1111-1111-7126 ( Other Identifier: WHO )
Study First Received: January 8, 2010
Results First Received: October 19, 2015
Last Updated: November 19, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Canada: Health Canada
India: Drugs Controller General of India
Mexico: Federal Commission for Protection Against Health Risks
South Africa: Medicines Control Council
Turkey: Ministry of Health
United States: Food and Drug Administration