NCT00982644|CompletedPhase 3Results

Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes

BEGIN™

NN1250-3579: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA and Insulin Glargine, Both Injected Once Daily in Combination With Oral Anti-diabetic Drugs (OAD), in Subjects With Type 2 Diabetes Mellitus Currently Treated With OAD(s) and Qualifying for More Intensified Treatment / NN1250-3643: An Extension Trial to NN1250-3579 Comparing Safety and Efficacy of NN1250 Plus OAD(s) With Insulin Glargine Plus OAD(s) in Type 2 Diabetes (BEGIN™: Once Long)

Novo Nordisk A/S ClinicalTrials.gov

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5 other identifiers

NN1250-35792008-005776-27U1111-1111-86922009-015754-38U1111-1114-9426

Study Type

interventional

Target

1,030

Locations

14 countries

Sites

183

Timeline

RegisteredSep 2009

StartedSep 2009

CompletionDec 2010

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes. All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued). Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week main trial. The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.

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

1,030

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Sep 2009

Geographic Reach

14 countries

183 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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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

1.2 years 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 13, 2015

Completed

Last Updated

February 9, 2017

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

September 22, 2009

Results QC Date

October 14, 2015

Last Update Submit

December 16, 2016

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 104 + 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 104 + 7 days follow up
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 of follow up

Secondary Outcomes (5)

Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Week 0 to Week 52 + 7 days follow up
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment
Week 0, Week 104
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 104
Week 104
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 degludec

IGlar OD

ACTIVE COMPARATOR

Drug: insulin glargine

Interventions

insulin degludecDRUG

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

IDeg OD

insulin glargineDRUG

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

IGlar OD

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes mellitus
Treatment with oral antidiabetic drugs (OADs) for at least three months before trial start at an unchanged dose
HbA1c: 7.0-10.0%
Body Mass Index (BMI) no higher than 40.0 kg/m\^2
For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3579 (NCT00982644)

You may not qualify if:

Treatment with exenatide or liraglutide within the last 3 months before trial start
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.