Brief Summary

This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with type 1 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

493

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Mar 2010

Geographic Reach

7 countries

82 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

March 1, 2010

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2010

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed

4.7 years until next milestone

Results Posted

Study results publicly available

December 31, 2015

Completed

Last Updated

February 9, 2017

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

March 2, 2010

Results QC Date

October 12, 2015

Last Update Submit

December 16, 2016

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (3)

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 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 52 + 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 52 + 7 days follow up

Secondary Outcomes (3)

Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Week 0, 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

Study Arms (3)

Flex + insulin aspart

EXPERIMENTAL

Drug: insulin degludecDrug: insulin aspart

Fixed + insulin aspart

EXPERIMENTAL

Drug: insulin degludecDrug: insulin aspart

IGlar + insulin aspart

ACTIVE COMPARATOR

Drug: insulin glargineDrug: insulin aspart

Interventions

insulin degludecDRUG

Injected subcutaneously (under the skin) once daily

Fixed + insulin aspartFlex + insulin aspart

insulin glargineDRUG

Insulin glargine injected subcutaneously (under the skin) once daily

IGlar + insulin aspart

insulin aspartDRUG

At least three daily doses at meal-time

Fixed + insulin aspartFlex + insulin aspartIGlar + insulin aspart

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies
Current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, NPH insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin) used as bolus insulin therapy
HbA1c maximum 10.0 % by central laboratory analysis
Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
Ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening
Ability and willingness to adhere to the protocol including performance of self measured plasma glucose (SMPG) profiles and self adjustment of insulin doses

You may not qualify if:

Use within the last 3 months prior to Visit 1 of any antidiabetic glucose lowering drug other than insulin
Cardiovascular disease, within the last 6 months prior to visit 1, 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
Uncontrolled treated/ untreated severe hypertension (systolic blood pressure above or equal to 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure above or equal to 100 mmHg)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)

Contact the study team to confirm eligibility.