NCT01006291|CompletedPhase 3Results

Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes

BEGIN™

A 26 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Three-arm, Treat to Target Trial Comparing Efficacy and Safety of Three Different Dosing Regimens of Either Soluble Insulin Basal Analogue (SIBA) or Insulin Glargine With or Without Combination With OAD Treatment, in Subjects With Type 2 Diabetes Mellitus (BEGIN™ : FLEX)

Novo Nordisk A/S ClinicalTrials.gov

Compare

3 other identifiers

NN1250-3668U1111-1111-70842008-005771-10

Study Type

interventional

Target

687

Locations

13 countries

Sites

Timeline

RegisteredNov 2009

StartedNov 2009

CompletionSep 2010

Brief Summary

This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should continue their current OAD treatment at the stable, prerandomisation dose level and dosing frequency.

Trial Health

On Track

Trial Health Score

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

Enrollment

687

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Nov 2009

Shorter than P25 for phase_3 diabetes

Geographic Reach

13 countries

71 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

10 months study duration

First Submitted

Initial submission to the registry

October 30, 2009

Completed

2 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed

5.2 years until next milestone

Results Posted

Study results publicly available

November 13, 2015

Completed

Last Updated

February 9, 2017

Status Verified

December 1, 2016

Enrollment Period

10 months

First QC Date

October 30, 2009

Results QC Date

October 12, 2015

Last Update Submit

December 16, 2016

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)

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Week 26
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

Study Arms (3)

IDeg OD FF

EXPERIMENTAL

Drug: insulin degludec

IDeg OD

EXPERIMENTAL

Drug: insulin degludec

IGlar OD

EXPERIMENTAL

Drug: insulin glargine

Interventions

insulin degludecDRUG

Injected s.c. (under the skin) once daily (alternative regimen). Dose was individually adjusted.

IDeg OD FF

insulin glargineDRUG

Insulin glargine injected s.c. (under the skin) once daily. Dose was individually adjusted.

IGlar OD

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1
HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs users 7.0-10.0% (both inclusive) by central laboratory analysis
Body Mass Index (BMI) below or equal to 40.0 kg/m\^2

You may not qualify if:

Cancer and medical history of cancer hereof
Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase-inhibitors
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 and squamous cell skin cancer)

Contact the study team to confirm eligibility.