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Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01059799
First received: January 29, 2010
Last updated: February 23, 2011
Last verified: December 2010
History of Changes
  Purpose

This trial is conducted in Asia and Japan. The aim of this trial is to compare NN1250 with insulin glargine both combined with oral anti-diabetic drugs (OADs) in subjects with type 2 diabetes never treated with insulin.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: NN1250
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 Pan Asian Trial Comparing Efficacy and Safety of Insulin NN1250 and Insulin Glargine as Add on to OAD(s) in Subjects With Type 2 Diabetes (BEGIN™: ONCE ASIA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of hypoglycaemic episodes [ Time Frame: over 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Plasma glucose profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 435
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NN1250 Drug: NN1250
NN1250 injected subcutaneously (under the skin) once daily. The doses will be individually adjusted
Active Comparator: Insulin glargine Drug: insulin glargine
Insulin glargine injected subcutaneously (under the skin) once daily. The doses 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:

  • For Japan only: minimum age is 20 years
  • Type 2 diabetes mellitus
  • Treatment with oral antidiabetic drugs for at least three months before trial start at an unchanged dose
  • HbA1c between 7.0 - 10.0%
  • BMI (Body Mass Index) no higher than 35.0 kg/m2

Exclusion Criteria:

  • Treatment with exenatide or liraglutide in the 3 months before trial start is not allowed
  • Cardiovascular disease within the last 6 months
  • Uncontrolled treated/untreated severe hypertension
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
  • Cancer and medical history of cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059799

Locations
Hong Kong
Hong Kong, Hong Kong
Japan
Sapporo-shi, Japan, 060 0002
Korea, Republic of
Incheon, Korea, Republic of, 400-103
Malaysia
Kubang Kerian, Kota Bharu, Malaysia, 16150
Taiwan
Pan-Chiao, Taiwan, 220
Thailand
Songkla, Thailand, 90110
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Sidse Schøtz, MSc 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: NCT01059799     History of Changes
Other Study ID Numbers: NN1250-3586, U1111-1113-2441, 101039
Study First Received: January 29, 2010
Last Updated: February 23, 2011
Health Authority: Hong Kong: Department of Health
Japan: Ministry of Health, Labor and Welfare
Malaysia: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Thailand: FDA Thailand

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 May 21, 2013