NCT01364428|CompletedPhase 3Results

Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus

BEGIN™

A Trial Comparing the Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Subjects With Type 2 Diabetes Mellitus (BEGIN™: COMPARE)

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN1250-3923U1111-1119-2518

Study Type

interventional

Target

373

Locations

1 country

Sites

Timeline

RegisteredJun 2011

StartedJun 2011

CompletionJan 2012

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

373

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Jun 2011

Shorter than P25 for phase_3 diabetes

Geographic Reach

1 country

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

7 months study duration

First Submitted

Initial submission to the registry

May 31, 2011

Completed

1 day until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed

3.9 years until next milestone

Results Posted

Study results publicly available

November 18, 2015

Completed

Last Updated

March 6, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

May 31, 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 22 weeks of treatment
Week 0, Week 22

Secondary Outcomes (4)

Change in Fasting Plasma Glucose (FPG)
Week 0, Week 22
Rate of Treatment Emergent Adverse Events (AEs)
Week 0 to Week 22 + 7 days follow up
Rate of Confirmed Hypoglycaemic Episodes
Week 0 to Week 22 + 7 days follow up
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Week 0 to Week 22 + 7 days follow up

Study Arms (2)

IDeg 200 U/mL

EXPERIMENTAL

Drug: insulin degludec

IDeg 100 U/mL

EXPERIMENTAL

Drug: insulin degludec

Interventions

insulin degludecDRUG

Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment. Dose was individually adjusted.

IDeg 200 U/mL

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation (visit 2)
Current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir once daily (OD), insulin glargine OD or neutral protamine hagedorn (NPH) insulin OD/twice daily (BID) for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of OAD(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase IV (DPP-IV) inhibitor in any approved (according to label) dose or combination. Stable OAD doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2)
HbA1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central laboratory analysis
Body mass index (BMI) below or equal to 45 kg/m\^2
Ability and willingness to adhere to the protocol including self-measured plasma glucose (SMPG) according to the protocol

You may not qualify if:

Treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2)
Treatment with glucagon like peptide-1 (GLP-1) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
Known or suspected hypersensitivity to trial products or related products
The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)

Contact the study team to confirm eligibility.