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Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus (BEGIN™)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01364428
First received: May 31, 2011
Last updated: May 10, 2012
Last verified: May 2012
History of Changes
  Purpose

This trial is conducted in the United States of America (USA). The aim of the trial is to compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: insulin degludec
 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 the Efficacy and Safety of Two Different Formulations of Insulin Degludec in Subjects With Type 2 Diabetes Mellitus ("BEGIN™: COMPARE")

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Percentage change from baseline in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in FPG (fasting plasma glucose) [ Time Frame: Week 0, week 22 ] [ Designated as safety issue: No ]
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: Weeks -1-23 ] [ Designated as safety issue: No ]
  • Number of severe and minor treatment emergent hypoglycaemic episodes [ Time Frame: Weeks 0-23 ] [ Designated as safety issue: No ]

Enrollment: 373
Study Start Date: June 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg formulation A Drug: insulin degludec

Injected subcutaneously, s.c. (under the skin) once daily, in combination with unchanged pre-trial OAD (oral anti-diabetic drug) treatment.

The dose will be individually adjusted.
Experimental: IDeg formulation B Drug: insulin degludec

Injected subcutaneously, s.c. (under the skin) once daily, in combination with unchanged pre-trial OAD (oral anti-diabetic drug) treatment.

The dose will be individually adjusted.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation (visit 2)
  • Current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir OD (once daily), insulin glargine OD or NPH insulin OD/BID for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of OAD(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase IV (DPP-IV inhibitor) in any approved (according to label) dose or combination. Stable OAD doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2)
  • HbA1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central laboratory analysis
  • BMI (Body Mass Index) below or equal to 45 kg/m^2
  • Ability and willingness to adhere to the protocol including SMPG (self-measured plasma glucose) according to the protocol

Exclusion Criteria:

  • Treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2)
  • Treatment with glucagon like peptide-1 (GLP-1) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
  • Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
  • Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
  • Known or suspected hypersensitivity to trial products or related products
  • The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364428

  Show 45 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Hani Yassin Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01364428     History of Changes
Other Study ID Numbers: NN1250-3923, U1111-1119-2518
Study First Received: May 31, 2011
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013