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Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin (BEGIN™)

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ClinicalTrials.gov Identifier: NCT01388361
Recruitment Status : Completed
First Posted : July 6, 2011
Results First Posted : November 26, 2015
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes.

Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.


Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec Drug: insulin aspart Drug: liraglutide Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 413 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Comparing the Efficacy and Safety of Adding Liraglutide Versus Addition of Insulin Aspart With the Largest Meal to Insulin Degludec, Both in Combination With Metformin, in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification (BEGIN™: VICTOZA® ADD-ON)
Study Start Date : September 2011
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: IDeg (non-randomised) Drug: insulin degludec
Injected s.c. (under the skin) once daily. The doses will be individually adjusted
Experimental: IDeg + IAsp Drug: insulin degludec
Injected s.c. (under the skin) once daily. The doses will be individually adjusted
Drug: insulin aspart
Injected s.c. (under the skin) once daily. The doses will be individually adjusted.
Experimental: IDeg + liraglutide Drug: insulin degludec
Injected s.c. (under the skin) once daily. The doses will be individually adjusted
Drug: liraglutide
Injected s.c. (under the skin) once daily. The doses will be individually adjusted.


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin) [ Time Frame: week 0, week 26 ]
    Values for change in HbA1c from baseline to 26 weeks of treatment period.


Secondary Outcome Measures :
  1. Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: week 0, week 26 ]
    Values for change in FPG in mmol/L from baseline to week 26 of randomised period.

  2. Change From Baseline in Body Weight [ Time Frame: week 0, week 26 ]
    Corresponds to the values of change in body weight in kilograms from baseline to week 26.

  3. Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes [ Time Frame: Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product. ]
    Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value < 3.1 mmol/L (56 mg/dL).


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
  • The subject must have completed the end of treatment visit of NN1250-3643 with Insulin degludec once daily + metformin.
  • Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol

Exclusion Criteria:

  • Participated in NN1250-3643 and treated with insulin glargine
  • Previous treatment with glucacon like peptide (GLP-1) receptor agonists (e.g. exenatide, liraglutide)
  • Impaired liver function, defined as alanine aminotransferase (ALAT) 2.5 times the upper limit of normal at end of treatment in NN1250-3643
  • Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for metformin [For France: glomerular filtration rate below 60 ml/min, calculated by the Cockroft & Gault formula] at end of treatment in NN1250-3643.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388361


  Show 124 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01388361     History of Changes
Other Study ID Numbers: NN1250-3948
2011-001493-25 ( EudraCT Number )
U1111-1120-2782 ( Other Identifier: WHO )
First Posted: July 6, 2011    Key Record Dates
Results First Posted: November 26, 2015
Last Update Posted: March 6, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Metformin
Liraglutide
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists