NCT01076647|CompletedPhase 3Results

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

BEGIN™

A 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of Insulin naïve Subjects With Type 2 Diabetes Mellitus Currently Treated With OADs Qualifying for Intensified Treatment (BEGIN™: EASY™)

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN1250-37182009-011399-31U1111-1112-8770

Study Type

interventional

Target

467

Locations

7 countries

Sites

105

Timeline

RegisteredFeb 2010

StartedMar 2010

CompletionDec 2010

Brief Summary

This trial was conducted in Europe and North America. The aim of this clinical trial was to compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs).

Trial Health

On Track

Trial Health Score

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

Enrollment

467

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Mar 2010

Shorter than P25 for phase_3 diabetes

Geographic Reach

7 countries

105 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

9 months study duration

First Submitted

Initial submission to the registry

February 25, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed

3 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed

4.9 years until next milestone

Results Posted

Study results publicly available

November 10, 2015

Completed

Last Updated

March 6, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

February 25, 2010

Results QC Date

October 13, 2015

Last Update Submit

January 20, 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 (1)

Change in Body Weight
Week 0, Week 26

Study Arms (2)

IDeg 3TW

EXPERIMENTAL

Drug: insulin degludec

IGlar OD

ACTIVE COMPARATOR

Drug: insulin glargine

Interventions

insulin degludecDRUG

Will be injected subcutaneously (under the skin) once daily three times weekly.

IDeg 3TW

insulin glargineDRUG

Will be injected subcutaneously (under the skin) once daily administered at the same time each day.

IGlar OD

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes (diagnosed clinically) for at least 6 months
Insulin naïve subjects (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
Current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily)-Insulin secretagogue (sulfonylurea (SU) or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
BMI (Body Mass Index) below or equal to 45.0 kg/m\^2

You may not qualify if:

Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs), 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, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

Contact the study team to confirm eligibility.