Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00972283
First received: September 3, 2009
Last updated: November 24, 2015
Last verified: November 2015
Results First Received: October 14, 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: insulin glargine
Drug: insulin aspart

  Participant Flow
  Hide Participant Flow

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 123 sites in 12 countries: Bulgaria (8 sites), Germany (8), Hong Kong (1), Ireland (4), Italy (11), Romania (5), Russia (6), Slovakia (4), South Africa (5), Spain (9), Turkey (3) and the United States (U.S.) (59). Some sites did not enroll subjects in the extension period. One site from United States was closed.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects who completed the 52-week main trial (NN1250-3582, NCT00972283) and were found to be eligible for the extension trial were offered to participate in the 26-week extension trial (NN1250-3667). The total duration of treatment was up to 78 weeks (52 weeks + 26 weeks).

Reporting Groups
  Description
IDeg OD Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
IGlar OD Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.

Participant Flow for 2 periods

Period 1:   Main: Week 0 to 52 (NN1250-3582)
    IDeg OD     IGlar OD  
STARTED     755     251  
Full Analysis Set     744 [1]   248 [2]
Exposed     753 [3]   251  
COMPLETED     618     211  
NOT COMPLETED     137     40  
Adverse Event                 31                 9  
Lack of Efficacy                 3                 0  
Protocol Violation                 23                 12  
Withdrawal criteria                 8                 2  
Unclassified                 72                 17  
[1] 11 subjects were excluded due to closure of a site
[2] 3 subjects were excluded due to closure of a site
[3] 2 subjects were withdrawn prior to exposure to trial products

Period 2:   Extension: Week 53 to 78 (NN1250-3667)
    IDeg OD     IGlar OD  
STARTED     566 [1]   191 [2]
COMPLETED     539     183  
NOT COMPLETED     27     8  
Adverse Event                 4                 0  
Lack of Efficacy                 1                 1  
Protocol Violation                 5                 0  
Withdrawal criteria                 6                 2  
Unclassified                 11                 5  
[1] 52 subjects did not continue into the extension from main trial
[2] 20 subjects did not continue into the extension from main trial



  Baseline Characteristics
  Hide Baseline Characteristics

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
IDeg OD Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
IGlar OD Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
Total Total of all reporting groups

Baseline Measures
    IDeg OD     IGlar OD     Total  
Number of Participants  
[units: participants]
  744     248     992  
Age  
[units: years]
Mean (Standard Deviation)
  59.2  (9.1)     58.1  (10.0)     58.9  (9.3)  
Gender  
[units: participants]
     
Female     339     115     454  
Male     405     133     538  
Glycosylated Haemoglobin (HbA1c)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  8.3  (0.8)     8.4  (0.9)     8.3  (0.8)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment   [ Time Frame: Week 0, Week 52 ]

2.  Primary:   Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 78 + 7 days follow up ]

3.  Primary:   Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 78 + 7 days follow up ]

4.  Primary:   Rate of Treatment Emergent Adverse Events (AEs)   [ Time Frame: Week 0 to Week 78 + 7 days follow up ]

5.  Secondary:   Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment   [ Time Frame: Week 0, Week 78 ]

6.  Secondary:   Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52   [ Time Frame: Week 52 ]

7.  Secondary:   Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 78   [ Time Frame: Week 78 ]

8.  Secondary:   Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 52 + 7 days follow up ]

9.  Secondary:   Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 52 + 7 days follow up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00972283     History of Changes
Obsolete Identifiers: NCT01193322
Other Study ID Numbers: NN1250-3582
2008-005777-35 ( EudraCT Number )
U1111-1111-8648 ( Other Identifier: WHO )
2009-015816-17 ( EudraCT Number )
U1111-1114-9067 ( Other Identifier: WHO )
Study First Received: September 3, 2009
Results First Received: October 14, 2015
Last Updated: November 24, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Bulgaria: Bulgarian Drug Agency
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Ireland: Irish Medicines Board
Spain: Spanish agency of medicines and health care products
South Africa: Medicines Control Council
Hong Kong: Department of Health
Russia: Federal Service for Control of Health Care and Social Development
Turkey: Ministry of Health Drug and Pharmaceutical Department
United States: Food and Drug Administration