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A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01849289
First Posted: May 8, 2013
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: Insulin Degludec Drug: Insulin Glargine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™: ONCE)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change From Baseline in HbA1c (%) (Analysed by Central Laboratory) [ Time Frame: Week 0, week 26 ]
    Change from baseline in HbA1c (%) after 26 weeks of treatment.


Secondary Outcome Measures:
  • Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes [ Time Frame: On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27) ]
    Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed PG value of less than 3.1 mmol/L (56 mg/dL).Minor hypoglycaemic episode is defined as an episode with symptoms consistent with hypoglycaemia with confirmation by full blood glucose < 2.8 mmol/L (50 mg/dL), or PG < 3.1 mmol/L (56 mg/dL) and which is handled by the subject himself/herself or any asymptomatic full blood glucose value < 2.8 mmol/L (50 mg/dL) or PG value < 3.1 mmol/L (56 mg/dL).

  • Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory) [ Time Frame: Week 0, week 26 ]
    Change from baseline in FPG after 26 weeks of treatment.

  • Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose) [ Time Frame: Week 26 ]
    Within subject Coefficient of variation(CV[%]) in pre-breakfast self measured plasma glucose for dose adjustment after 26 treatment weeks are displayed below.

  • Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes [ Time Frame: Week 26 ]
    A responder for HbA1c without severe or confirmed hypoglycaemia is defined as a subject, who meets the HbA1c target at end of trial without treatment emergent severe or confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days from last treatment.

  • Number of Treatment Emergent AEs (Adverse Events) [ Time Frame: On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27) ]
    Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)


Enrollment: 833
Actual Study Start Date: June 2, 2013
Study Completion Date: May 15, 2014
Primary Completion Date: May 15, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin Degludec Drug: Insulin Degludec
Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.
Other Name: NN1250
Experimental: Insulin Glargine Drug: Insulin Glargine
Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.

  Eligibility

Information from the National Library of Medicine

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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:

  • Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
  • Insulin naïve subjects (Allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
  • Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to randomisation (Visit 2) with the minimum doses stated: metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling, DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
  • HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratory analysis
  • BMI (Body Mass Index) below or equal to 40.0 kg/m^2

Exclusion Criteria:

  • Treatment with TZDs (thiazoledinedione), or GLP-1 (glucagon-like peptide 1) receptor agonists within the last 3 months prior to Visit 1 (screening)
  • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (monoamine oxidase) inhibitors
  • Cardiovascular disease within the last 6 months prior to Visit 1 (screening) defined as stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes mellitus, which in the Investigator's opinion could interfere with the results of the trial
  • Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
  • Known or suspected hypersensitivity to trial product(s) or related products
  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): NCT01849289


  Hide Study Locations
Locations
United States, California
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801
Novo Nordisk Investigational Site
Lomita, California, United States, 90717
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90057
United States, Colorado
Novo Nordisk Investigational Site
Golden, Colorado, United States, 80401
United States, Florida
Novo Nordisk Investigational Site
Clearwater, Florida, United States, 33765
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60607
United States, Kentucky
Novo Nordisk Investigational Site
Crestview Hills, Kentucky, United States, 41017-3464
United States, Louisiana
Novo Nordisk Investigational Site
Metairie, Louisiana, United States, 70002
United States, Michigan
Novo Nordisk Investigational Site
Troy, Michigan, United States, 48098
United States, Missouri
Novo Nordisk Investigational Site
Chesterfield, Missouri, United States, 63017
United States, New Hampshire
Novo Nordisk Investigational Site
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Novo Nordisk Investigational Site
Toms River, New Jersey, United States, 08755-8050
United States, New York
Novo Nordisk Investigational Site
Smithtown, New York, United States, 11787
United States, South Carolina
Novo Nordisk Investigational Site
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Novo Nordisk Investigational Site
Jackson, Tennessee, United States, 38305
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
United States, Virginia
Novo Nordisk Investigational Site
Newport News, Virginia, United States, 23606
United States, Wisconsin
Novo Nordisk Investigational Site
Kenosha, Wisconsin, United States, 53142
Brazil
Novo Nordisk Investigational Site
São Paulo, Sao Paulo, Brazil, 01244-030
Novo Nordisk Investigational Site
Porto Alegre, Brazil, 90035-170
Novo Nordisk Investigational Site
São Paulo, Brazil, 04022-002
Canada, Alberta
Novo Nordisk Investigational Site
Calgary, Alberta, Canada, T2N 4L7
Canada, British Columbia
Novo Nordisk Investigational Site
Burnaby, British Columbia, Canada, V5G 1T4
Novo Nordisk Investigational Site
Surrey, British Columbia, Canada, V3S 2N6
Novo Nordisk Investigational Site
Victoria, British Columbia, Canada, V8V 4A1
Canada, Ontario
Novo Nordisk Investigational Site
Burlington, Ontario, Canada, L7M 4Y1
Novo Nordisk Investigational Site
London, Ontario, Canada, N5W 6A2
Novo Nordisk Investigational Site
London, Ontario, Canada, N6P 1A9
Novo Nordisk Investigational Site
Newmarket, Ontario, Canada, L3Y 5G8
Novo Nordisk Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
Novo Nordisk Investigational Site
Strathroy, Ontario, Canada, N7G 1Y7
Canada, Quebec
Novo Nordisk Investigational Site
Trois Rivieres, Quebec, Canada, G8T7A1
Canada
Novo Nordisk Investigational Site
Quebec, Canada, G3K 2P8
China, Anhui
Novo Nordisk Investigational Site
Hefei, Anhui, China, 230001
China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100029
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100039
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100191
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100700
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100730
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100853
China, Chongqing
Novo Nordisk Investigational Site
Chongqing, Chongqing, China, 400010
Novo Nordisk Investigational Site
Chongqing, Chongqing, China, 400016
Novo Nordisk Investigational Site
ChongQing, Chongqing, China, 404000
China, Fujian
Novo Nordisk Investigational Site
Fuzhou, Fujian, China, 350025
China, Guangdong
Novo Nordisk Investigational Site
Guangzhou, Guangdong, China, 510120
China, Guangxi
Novo Nordisk Investigational Site
Nanning, Guangxi, China, 530007
China, Guizhou
Novo Nordisk Investigational Site
Guiyang, Guizhou, China, 550004
China, Hebei
Novo Nordisk Investigational Site
Shijiazhuang, Hebei, China, 050051
Novo Nordisk Investigational Site
Shijiazhuang, Hebei, China, 050082
China, Heilongjiang
Novo Nordisk Investigational Site
Harbin, Heilongjiang, China, 150086
China, Hubei
Novo Nordisk Investigational Site
Wuhan, Hubei, China, 430030
Novo Nordisk Investigational Site
Wuhan, Hubei, China, 430034
China, Hunan
Novo Nordisk Investigational Site
Yueyang, Hunan, China, 414000
China, Jiangsu
Novo Nordisk Investigational Site
Yangzhou, Jiangsu, China, 225001
Novo Nordisk Investigational Site
Zhenjiang, Jiangsu, China, 212001
China, Jiangxi
Novo Nordisk Investigational Site
Nanchang, Jiangxi, China, 330006
China, Jilin
Novo Nordisk Investigational Site
Changchun, Jilin, China, 130041
Novo Nordisk Investigational Site
Siping, Jilin, China, 136000
China, Liaoning
Novo Nordisk Investigational Site
Shenyang, Liaoning, China, 110004
Novo Nordisk Investigational Site
Shenyang, Liaoning, China, 110021
China, Shaanxi
Novo Nordisk Investigational Site
Xi'an, Shaanxi, China, 710032
China, Shanghai
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200040
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200072
China, Yunnan
Novo Nordisk Investigational Site
Kunming, Yunnan, China, 650101
China, Zhejiang
Novo Nordisk Investigational Site
Hangzhou, Zhejiang, China, 310003
Novo Nordisk Investigational Site
Wenzhou, Zhejiang, China, 325000
Romania
Novo Nordisk Investigational Site
Oradea, Bihor, Romania, 410469
Novo Nordisk Investigational Site
Bucharest, Romania, 020614
Novo Nordisk Investigational Site
Buzau, Romania, 120203
Novo Nordisk Investigational Site
Galati, Romania, 800578
Novo Nordisk Investigational Site
Sibiu, Romania, 550176
South Africa
Novo Nordisk Investigational Site
George, Eastern Cape, South Africa, 6529
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 1812
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2193
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4001
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4091
Ukraine
Novo Nordisk Investigational Site
Dnepropetrovsk, Ukraine, 49005
Novo Nordisk Investigational Site
Dnepropetrovsk, Ukraine, 49038
Novo Nordisk Investigational Site
Kiev, Ukraine, 04114
Novo Nordisk Investigational Site
Mykolaiv, Ukraine, 54003
Novo Nordisk Investigational Site
Vinnitsa, Ukraine, 21010
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: NCT01849289     History of Changes
Other Study ID Numbers: NN1250-3587
U1111-1121-5325 ( Other Identifier: WHO )
First Submitted: May 6, 2013
First Posted: May 8, 2013
Results First Submitted: October 16, 2015
Results First Posted: January 14, 2016
Last Update Posted: April 7, 2017
Last Verified: March 2017

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