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Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01135992
First received: May 31, 2010
Last updated: September 22, 2011
Last verified: September 2011
History of Changes
  Purpose

This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess the implications of switching from insulin glargine to insulin degludec in subjects with type 2 diabetes mellitus.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial Assessing the Implications of Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™: SIMPLIFY)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: after 12 weeks of insulin degludec treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in fasting plasma glucose (FPG) [ Time Frame: after 12 weeks of insulin degludec treatment ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: after 12 weeks of insulin degludec treatment ] [ Designated as safety issue: No ]
  • Number of treatment emergent adverse events (AEs) [ Time Frame: weeks 0-4, weeks 4-16 ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: weeks 0-4, weeks 4-16 ] [ Designated as safety issue: No ]

Enrollment: 143
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: insulin degludec
Individually adjusted insulin degludec administered three times weekly with continued unchanged pre-trial OAD (oral anti-diabetic drug) treatment for 12 weeks
Drug: insulin glargine
Subjects continue their pre-trial insulin glargine once daily plus OAD (oral anti-diabetic drug) treatment for four weeks before switch to insulin degludec

  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
  • HbA1c below or equal to 10% by central laboratory analysis
  • Current treatment with basal-oral therapy (no prandial insulin) of insulin glargine once daily for at least three months combined with OAD treatment

Exclusion Criteria:

  • Use within the last three months prior to trial start of: exenatide, liraglutide or thiazoledinediones (TZDs) other than pioglitazone
  • Recent (within the last 6 months) cardiovascular disease (CVD) or congestive heart failure (CHF) (NYHA class III or IV)
  • Recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the last 12 months), or hypoglycaemic unawareness as judged by the physician, or hospitalisation for diabetic ketoacidosis during the previous six months
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
  • Previous participation in this trial. Participation is defined as started on trial medication. Re-screening of screening failures is allowed only once within the limits of the recruitment period
  • Known or suspected hypersensitivity to trial products or related products
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01135992

  Show 28 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: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01135992     History of Changes
Other Study ID Numbers: NN1250-3839, U1111-1114-8802
Study First Received: May 31, 2010
Last Updated: September 22, 2011
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
Glargine
 Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013