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Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01326026
First received: March 29, 2011
Last updated: January 20, 2017
Last verified: January 2017
  Purpose
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different self-titration algorithms (dose individually adjusted) in combination with metformin.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Trial Comparing the Efficacy and Safety of Insulin Degludec Once Daily in Insulin naïve Subjects With Type 2 Diabetes Mellitus When Titrated Using Two Different Titration Algorithms (BEGIN™: ONCE SIMPLE USE)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ]
    Change from baseline in HbA1c after 26 weeks of treatment.


Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, Week 26 ]
    Change from baseline in FPG after 26 weeks of treatment.

  • Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 26 + 7 days follow up ]
    Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.

  • Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ]
    Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.

  • Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ]
    Observed rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.


Enrollment: 222
Study Start Date: March 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg Simple Drug: insulin degludec
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Experimental: IDeg Step wise Drug: insulin degludec
Injected subcutaneously (under the skin) once daily. Dose individually adjusted in a stepwise manner.

  Eligibility

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

Inclusion Criteria:

  • Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation (Visit 2)
  • Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
  • HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
  • BMI (Body Mass Index) no higher than 45.0 kg/m^2

Exclusion Criteria:

  • Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2
  • Suffer from a life threatening disease (e.g. cancer)
  • Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise [for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner])
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326026

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35216
Novo Nordisk Investigational Site
Huntsville, Alabama, United States, 35801
United States, California
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801
Novo Nordisk Investigational Site
La Jolla, California, United States, 92037
Novo Nordisk Investigational Site
Mission Hills, California, United States, 91345
Novo Nordisk Investigational Site
National City, California, United States, 91950
Novo Nordisk Investigational Site
North Hollywood, California, United States, 91606
Novo Nordisk Investigational Site
San Diego, California, United States, 92111
United States, Colorado
Novo Nordisk Investigational Site
Golden, Colorado, United States, 80401
United States, Florida
Novo Nordisk Investigational Site
Kissimmee, Florida, United States, 34741
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33603
United States, Georgia
Novo Nordisk Investigational Site
Columbus, Georgia, United States, 31909
United States, Illinois
Novo Nordisk Investigational Site
Springfield, Illinois, United States, 62711
United States, Indiana
Novo Nordisk Investigational Site
Evansville, Indiana, United States, 47714
United States, Louisiana
Novo Nordisk Investigational Site
Slidell, Louisiana, United States, 70461-4231
United States, Montana
Novo Nordisk Investigational Site
Billings, Montana, United States, 59102
United States, New York
Novo Nordisk Investigational Site
Staten Island, New York, United States, 10301
United States, North Carolina
Novo Nordisk Investigational Site
Greensboro, North Carolina, United States, 27408
United States, Ohio
Novo Nordisk Investigational Site
Franklin, Ohio, United States, 45005
United States, Pennsylvania
Novo Nordisk Investigational Site
Melrose Park, Pennsylvania, United States, 19027
United States, Rhode Island
Novo Nordisk Investigational Site
East Providence, Rhode Island, United States, 02914
United States, Tennessee
Novo Nordisk Investigational Site
Humboldt, Tennessee, United States, 38343
United States, Texas
Novo Nordisk Investigational Site
Houston, Texas, United States, 77095
Novo Nordisk Investigational Site
Killeen, Texas, United States, 76543-5600
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78224
United States, Utah
Novo Nordisk Investigational Site
Ogden, Utah, United States, 84403
Novo Nordisk Investigational Site
St. George, Utah, United States, 84790
Finland
Novo Nordisk Investigational Site
Helsinki, Finland, 00260
Novo Nordisk Investigational Site
Kerava, Finland, FI-04200
Novo Nordisk Investigational Site
Tampere, Finland, 33210
Novo Nordisk Investigational Site
Turku, Finland, 20520
Novo Nordisk Investigational Site
Turku, Finland, FI-20100
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 12163
Novo Nordisk Investigational Site
Friedrichsthal, Germany, 66299
Novo Nordisk Investigational Site
Hohenmölsen, Germany, 06679
Novo Nordisk Investigational Site
Münster, Germany, 48145
Novo Nordisk Investigational Site
Neuwied, Germany, 56564
Novo Nordisk Investigational Site
Völklingen, Germany, 66333
Spain
Novo Nordisk Investigational Site
Almería, Spain, 04001
Novo Nordisk Investigational Site
Antequera, Spain, 29200
Novo Nordisk Investigational Site
Gijón, Spain, 33206
Novo Nordisk Investigational Site
Málaga, Spain, 29006
Novo Nordisk Investigational Site
Palma de Mallorca, Spain, 07014
Novo Nordisk Investigational Site
Palma de Mallorca, Spain, 07198
Novo Nordisk Investigational Site
Pozuelo de Alarcon, Spain, 28223
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: NCT01326026     History of Changes
Other Study ID Numbers: NN1250-3846
U1111-1117-0616 ( Other Identifier: WHO )
2010-022337-29 ( EudraCT Number )
Study First Received: March 29, 2011
Results First Received: October 16, 2015
Last Updated: January 20, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017