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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01059799
First received: January 29, 2010
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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


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 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:


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

Primary Outcome Measures:
  • Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) [ Time Frame: Week 26 ] [ 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: IDeg OD Drug: insulin degludec
Insulin degludec injected subcutaneously (under the skin) once daily. The doses will be individually adjusted
Active Comparator: IGlar OD 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 (diagnosed clinically) for at least 6 months
  • Current treatment with monotherapy or combination of an insulin secretagouge (sulfonylurea or glinide) and metformin, with or without addition of alfa-glucosidase-inhibitors or a DPP-4 inhibitor with unchanged dosing for at least 3 months prior to visit 1. The dose(s) should as minimum be as stated: -Insulin secretagogue (sulfonylurea or glinide): Minimum half of the daily maximal dose according to local labelling -Metformin: alone or in combination (including fixed combination): Maximum tolerated dose - alfa-glucosidase-inhibitors: Minimum half of the daily maximal dose or maximum tolerated dose -DPP-4 (dipeptyl peptidase 4) inhibitor: According to local labelling
  • HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
  • Body Mass Index (BMI) no higher than 35.0 kg/m^2

Exclusion Criteria:

  • Use within the last 3 months prior to Visit 1 of: TZDs (thiazolidinediones), exenatide or liraglutide
  • Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
  • Pregnancy, breast-feeding, or the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for Thailand: adequate contraceptive measures are: diaphragm, condom (by the partner), intrauterine device in place for last three months before trial starts, sponge, cap with spermicide, contraceptive patch, approved hormonal implant (i.e. Norplant), oral contraceptives taken without difficulty for the last three months before trial starts, post menopausal state or sterilisation.)
  • Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
  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: NCT01059799

Locations
Hong Kong
Hong Kong, Hong Kong
Japan
Sapporo-shi, Japan, 060 0002
Korea, Republic of
Incheon, Korea, Republic of, 400-103
Malaysia
Kota Bharu, Kelantan, Malaysia, 16150
Taiwan
Pan-Chiao, Taiwan, 220
Thailand
Songkla, Thailand, 90110
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Sidse Schøtz, MSc Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01059799     History of Changes
Other Study ID Numbers: NN1250-3586, U1111-1113-2441, JapicCTI-101039
Study First Received: January 29, 2010
Last Updated: November 21, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Malaysia: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Hong Kong: Department of Health
Thailand: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014