NCT01135992|CompletedPhase 3Results

Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)

BEGIN™

A Trial Assessing the Implications of Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™: SIMPLIFY)

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN1250-3839U1111-1114-8802

Study Type

interventional

Target

143

Locations

1 country

Sites

Timeline

RegisteredJun 2010

StartedJun 2010

CompletionNov 2010

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in subjects with type 2 diabetes mellitus.

Trial Health

On Track

Trial Health Score

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

Enrollment

143

participants targeted

Target at below P25 for phase_3 diabetes

Timeline

Completed

Started Jun 2010

Shorter than P25 for phase_3 diabetes

Geographic Reach

1 country

27 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

5 months study duration

First Submitted

Initial submission to the registry

May 31, 2010

Completed

1 day until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed

5.2 years until next milestone

Results Posted

Study results publicly available

January 22, 2016

Completed

Last Updated

January 22, 2016

Status Verified

December 1, 2015

Enrollment Period

5 months

First QC Date

May 31, 2010

Results QC Date

October 16, 2015

Last Update Submit

December 14, 2015

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c (Glycosylated Haemoglobin)
HbA1C at week 4 and 16
Week 4 and Week 16

Secondary Outcomes (5)

Fasting Plasma Glucose (FPG)
Week 4 and Week 16
Change in Body Weight
Week 0, Week 4, Week 16
Rate of Treatment Emergent Adverse Events (AEs)
Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)
Rate of Confirmed Hypoglycaemic Episodes
Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)

Study Arms (2)

IGlar/IDeg

EXPERIMENTAL

Drug: insulin glargine

IDeg 3TW

EXPERIMENTAL

Drug: insulin degludec

Interventions

insulin degludecDRUG

Individually adjusted insulin degludec administered three times weekly with continued unchanged pre-trial OAD (oral anti-diabetic drug) treatment for 12 weeks

IDeg 3TW

insulin glargineDRUG

Subjects continue their pre-trial insulin glargine once daily plus OAD (oral anti-diabetic drug) treatment for four weeks before switch to insulin degludec

IGlar/IDeg

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
HbA1c maximum 10 % by central laboratory analysis
Current treatment with basal-oral therapy (BOT) (no prandial insulin ever) consisting of: at least three months with insulin glargine once daily (average prescribed dose must have been unchanged (within plus/minus 10%) for four weeks prior to Visit 1 as confirmed by patient records or verbal confirmation by the subject) in combination with stable (unchanged doses for at least 3 months prior to Visit 1) OAD (metformin, insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor) treatment in any approved (according to label) dose or combination

You may not qualify if:

Use within the last three months prior to Visit 1 of: Exenatide, Liraglutide or Thiazoledinediones (TZDs) other than Pioglitazone
Cardiovascular disease (CVD) 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 within the last six months prior to Visit 1
Recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the last 12 months), or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous six months
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Previous participation in this trial. Participation is defined as started on trial medication. Rescreening of screening failures is allowed only once within the limits of the recruitment period
Known or suspected hypersensitivity to trial products or related products

Contact the study team to confirm eligibility.