NCT01059799|CompletedPhase 3Results

Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes

BEGIN™

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)

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN1250-3586U1111-1113-2441JapicCTI-101039

Study Type

interventional

Target

435

Locations

6 countries

Sites

Timeline

RegisteredFeb 2010

StartedFeb 2010

CompletionDec 2010

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

435

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Feb 2010

Shorter than P25 for phase_3 diabetes

Geographic Reach

6 countries

53 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

January 29, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2010

Completed

Same day until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2010

Completed

4.9 years until next milestone

Results Posted

Study results publicly available

November 13, 2015

Completed

Last Updated

March 30, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

January 29, 2010

Results QC Date

October 12, 2015

Last Update Submit

February 28, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline in HbA1c after 26 weeks of treatment
Week 0, Week 26

Secondary Outcomes (3)

Rate of Confirmed Hypoglycaemic Episodes
Week 0 to Week 26 + 7 days follow up
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Week 0 to Week 26 + 7 days follow up
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Week 26

Study Arms (2)

IDeg OD

EXPERIMENTAL

Drug: insulin degludec

IGlar OD

ACTIVE COMPARATOR

Drug: insulin glargine

Interventions

insulin degludecDRUG

Insulin degludec injected subcutaneously (under the skin) once daily. The doses will be individually adjusted

IDeg OD

insulin glargineDRUG

Insulin glargine injected subcutaneously (under the skin) once daily. The doses will be individually adjusted

IGlar OD

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.