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NCT Number: NCT01388361

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Feldkirch, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin degludec

Drug

Injected s.c. (under the skin) once daily. The doses will be individually adjusted

insulin aspart

Drug

Injected s.c. (under the skin) once daily. The doses will be individually adjusted.

liraglutide

Drug

Injected s.c. (under the skin) once daily. The doses will be individually adjusted.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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)

Acronym: BEGIN™

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 6, 2011
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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