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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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01849289
First received: May 6, 2013
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

This trial is conducted in Africa, Asia, North and South America. The aim of the trial is 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • Change from baseline in FPG (fasting plasma glucose) (analysed by central laboratory) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Within-subject variability as measured by coefficient of variation (CV%) in pre-breakfast SMPG (self-measured plasma glucose) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Responder for HbA1c (below 7.0%) at end of trial without severe and minor hypoglycaemic episodes [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 833
Study Start Date: June 2013
Study Completion Date: May 2014
Primary Completion Date: May 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
Active Comparator: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01849289

  Show 19 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:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01849289     History of Changes
Other Study ID Numbers: NN1250-3587, U1111-1121-5325, CTR20130105, 2009-017813-32
Study First Received: May 6, 2013
Last Updated: September 30, 2014
Health Authority: Brazil: National Health Surveillance Agency
Canada: Public Health Agency of Canada
China: Ministry of Health
South Africa: Medicines Control Council
Ukraine: Ministry of Health Ukraine
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014