NCT01074268|CompletedPhase 3Results

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

BEGIN™

NN1250-3585: A Trial Investigating the Efficacy and Safety of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen / NN1250-3725: An Extension Trial to NN1250-3585 Investigating Safety and Efficacy of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen (BEGIN™: BB T1)

Novo Nordisk A/S ClinicalTrials.gov

Compare

7 other identifiers

NN1250-35852009-011672-29U1111-1111-7249JapicCTI-1010672009-015721-36U1111-1114-9479JapicCTI-22-0677

Study Type

interventional

Target

456

Locations

8 countries

Sites

Timeline

RegisteredFeb 2010

StartedFeb 2010

CompletionDec 2010

Brief Summary

This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec (\[Deg\]) with insulin detemir (IDet), both combined with insulin aspart. The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.

Trial Health

On Track

Trial Health Score

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

Enrollment

456

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Feb 2010

Shorter than P25 for phase_3 diabetes

Geographic Reach

8 countries

69 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

10 months study duration

Study Start

First participant enrolled

February 1, 2010

Completed

21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2010

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed

5 years until next milestone

Results Posted

Study results publicly available

November 16, 2015

Completed

Last Updated

March 6, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

February 22, 2010

Results QC Date

October 15, 2015

Last Update Submit

January 20, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Change from baseline in HbA1c after 26 weeks of treatment
Week 0, Week 26
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no/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 or important medical issues
Week 0 to Week 52 + 7 days follow up

Secondary Outcomes (9)

Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Week 0, Week 52
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
Week 26
Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52
Week 52
Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment
Week 0, Week 26
Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
Week 0, Week 52
+4 more secondary outcomes

Study Arms (2)

IDeg OD

EXPERIMENTAL

Drug: insulin degludecDrug: insulin aspart

IDet

ACTIVE COMPARATOR

Drug: insulin detemirDrug: insulin aspart

Interventions

insulin degludecDRUG

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

IDeg OD

insulin detemirDRUG

Injected s.c. (under the skin) once daily or twice daily (BID). Dose was individually adjusted.

IDet

insulin aspartDRUG

Injected s.c. (under the skin) as mealtime insulin. Dose was individually adjusted.

IDeg ODIDet

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%
Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
For Japan only: Minimum age is 20 years
For the extension trial only: Completed the six-month treatment period in trial NN1250-3585 (NCT01074268)

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
Cancer and medical history of cancer

Contact the study team to confirm eligibility.