NCT00972283|CompletedPhase 3Results

Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes

BEGIN™

NN1250-3582: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational 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 ± Treatment With Metformin, ± Pioglitazone in Subjects With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment/NN1250-3667: An Extension Trial to NN1250-3582 Comparing Safety and Efficacy of NN1250 and Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin ± OADs in Type 2 Diabetes (BEGIN™: BB)

Novo Nordisk A/S ClinicalTrials.gov

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5 other identifiers

NN1250-35822008-005777-35U1111-1111-86482009-015816-17U1111-1114-9067

Study Type

interventional

Target

1,006

Locations

12 countries

Sites

136

Timeline

RegisteredSep 2009

StartedSep 2009

CompletionOct 2010

Brief Summary

This trial is conducted in Africa, Asia, Europe, and the United States of America (USA). The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes. All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone. Subjects who consent to participate in the extension trial (NN1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582. The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension period is registered as NN1250-3667.

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

1,006

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Sep 2009

Geographic Reach

12 countries

136 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

2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2010

Completed

5 years until next milestone

Results Posted

Study results publicly available

November 13, 2015

Completed

Last Updated

April 6, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

September 3, 2009

Results QC Date

October 14, 2015

Last Update Submit

March 8, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

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 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 78 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Nocturnal 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. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Week 0 to Week 78 + 7 days follow up
Rate of Treatment Emergent Adverse Events (AEs)
Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): 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 78 + 7 days follow up

Secondary Outcomes (5)

Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment
Week 0, Week 78
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52
Week 52
Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 78
Week 78
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

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 (under the skin) with main evening meal. Dose was individually adjusted.

IDeg OD

insulin glargineDRUG

Injected subcutanoeusly (under the skin) according to approved label. Dose was individually adjusted.

IGlar OD

insulin aspartDRUG

Injected subcutaneously (under the skin) at each main meal. 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:

For MAIN period (NN1250-3582):
Type 2 diabetes mellitus for at least 6 months
Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without oral anti-diabetics drug (OAD) prior to trial start
HbA1c 7.0-10.0 % (both inclusive)
Body Mass Index (BMI) below or equal to 40.0 kg/m\^2
For EXTENSION period (NN1250-3667):
Completion of the 52 week treatment period in NN1250-3582

You may not qualify if:

For MAIN period (NN1250-3582):
Treatment with other insulin regimens than premix, self-mix, basal only, basal bolus within 3 months
Cardiovascular disease within the last 6 months
Uncontrolled treated/untreated severe hypertension
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.