NCT01326026|CompletedPhase 3Results

Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus

BEGIN™

A Trial Comparing the Efficacy and Safety of Insulin Degludec Once Daily in Insulin naïve Subjects With Type 2 Diabetes Mellitus When Titrated Using Two Different Titration Algorithms (BEGIN™: ONCE SIMPLE USE)

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN1250-3846U1111-1117-06162010-022337-29

Study Type

interventional

Target

222

Locations

4 countries

Sites

Timeline

RegisteredMar 2011

StartedMar 2011

CompletionDec 2011

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different self-titration algorithms (dose individually adjusted) in combination with metformin.

Trial Health

On Track

Trial Health Score

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

Enrollment

222

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Mar 2011

Shorter than P25 for phase_3 diabetes

Geographic Reach

4 countries

45 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

Study Start

First participant enrolled

March 1, 2011

Completed

28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed

4 years until next milestone

Results Posted

Study results publicly available

November 17, 2015

Completed

Last Updated

March 6, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

March 29, 2011

Results QC Date

October 16, 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 (4)

Change in Fasting Plasma Glucose (FPG)
Week 0, Week 26
Rate of Treatment Emergent Adverse Events (AEs)
Week 0 to Week 26 + 7 days follow up
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 (2)

IDeg Simple

EXPERIMENTAL

Drug: insulin degludec

IDeg Step wise

EXPERIMENTAL

Drug: insulin degludec

Interventions

insulin degludecDRUG

Injected subcutaneously (under the skin) once daily. Dose individually adjusted.

IDeg Simple

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 24 weeks prior to randomisation (Visit 2)
Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
BMI (Body Mass Index) no higher than 45.0 kg/m\^2

You may not qualify if:

Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2
Suffer from a life threatening disease (e.g. cancer)
Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise \[for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner\])

Contact the study team to confirm eligibility.