NCT00982228|CompletedPhase 3Results

Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes

BEGIN™

NN1250-3583: A 52 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Parallel, Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (BEGIN™: BB T1 LONG) / NN1250-3644: An Extension Trial to Trial NN1250-3583 Comparing Safety and Efficacy of NN1250 With Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin, in Type 1 Diabetes (BEGIN™: T1)

Novo Nordisk A/S ClinicalTrials.gov

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5 other identifiers

NN1250-35832008-005774-13U1111-1111-87892009-015755-24U1111-1116-1578

Study Type

interventional

Target

629

Locations

6 countries

Sites

Timeline

RegisteredSep 2009

StartedSep 2009

CompletionNov 2010

Brief Summary

This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes. The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.

Trial Health

On Track

Trial Health Score

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

Enrollment

629

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Sep 2009

Geographic Reach

6 countries

91 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

1.2 years study duration

Study Start

First participant enrolled

September 1, 2009

Completed

21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2010

Completed

5.1 years until next milestone

Results Posted

Study results publicly available

December 29, 2015

Completed

Last Updated

April 6, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

September 22, 2009

Results QC Date

October 14, 2015

Last Update Submit

March 8, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (4)

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Change from baseline in HbA1c after 52 weeks of treatment
Week 0, Week 52
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Week 0 to Week 104 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Week 0 to Week 104 + 7 days follow up
Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin
The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period.
Week 0, Week 106

Secondary Outcomes (6)

Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Week 0 to Week 104 + 7 days follow up
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment
Week 0, Week 104
Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment
Treatment week 104
Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Week 0 to Week 52 + 7 days follow up
Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Week 0 to Week 52 + 7 days follow up
+1 more secondary outcomes

Study Arms (2)

IDeg OD

EXPERIMENTAL

Drug: insulin degludecDrug: insulin aspart

IGlar OD

ACTIVE COMPARATOR

Drug: insulin glargineDrug: insulin aspart

Interventions

insulin degludecDRUG

Injected subcutaneously once daily. Dose was individually adjusted.

IDeg OD

insulin glargineDRUG

Injected subcutaneously once daily. Dose individually adjusted.

IGlar OD

insulin aspartDRUG

Injected subcutaneously as mealtime insulin. Dose was individually adjusted.

IDeg ODIGlar OD

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 1 diabetes mellitus for at least 12 months
Current treatment with any basal bolus insulin for at least 12 months
HbA1c below or equal to 10.0%
BMI (Body Mass Index) below or equal to 35.0 kg/m\^2
For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228)

You may not qualify if:

Use of any other antidiabetic drug than insulin within the last 3 months
Cardiovascular disease within the last 6 months
Uncontrolled treated/untreated severe hypertension
Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Cancer and medical history of cancer

Contact the study team to confirm eligibility.