NCT02034513|CompletedPhase 3Results

A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes

SWITCH 1

A Randomised, Double Blind, Cross-over Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (SWITCH 1)

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN1250-3995U1111-1129-96682012-001930-32

Study Type

interventional

Target

501

Locations

3 countries

Sites

Timeline

RegisteredJan 2014

StartedJan 2014

CompletionJan 2016

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar), both with insulin aspart (IAsp) as mealtime insulin in subjects with type 1 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

501

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Jan 2014

Typical duration for phase_3 diabetes

Geographic Reach

3 countries

99 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

2 years study duration

Study Start

First participant enrolled

January 5, 2014

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed

6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2016

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

May 15, 2017

Completed

Last Updated

January 2, 2019

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

January 7, 2014

Results QC Date

January 11, 2017

Last Update Submit

December 7, 2018

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period
Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \<3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Maintenance period: 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64).
A 16-week treatment period.

Secondary Outcomes (5)

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period
After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period
After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
Incidence of Treatment Emergent Adverse Events
During 32 weeks of treatment for each treatment period
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Week 32, Week 64
FPG (Fasting Plasma Glucose)
Week 32 and Week 64

Study Arms (2)

IDeg OD + IAsp followed by IGlar OD + IAsp

EXPERIMENTAL

Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period

Drug: insulin degludecDrug: insulin glargineDrug: insulin aspart

IGlar OD + IAsp followed by IDeg OD + IAsp

ACTIVE COMPARATOR

Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period

Drug: insulin degludecDrug: insulin glargineDrug: insulin aspart

Interventions

insulin degludecDRUG

Administered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

IDeg OD + IAsp followed by IGlar OD + IAspIGlar OD + IAsp followed by IDeg OD + IAsp

insulin glargineDRUG

Administered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

IDeg OD + IAsp followed by IGlar OD + IAspIGlar OD + IAsp followed by IDeg OD + IAsp

insulin aspartDRUG

Administered 2-4 times daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

IDeg OD + IAsp followed by IGlar OD + IAspIGlar OD + IAsp followed by IDeg OD + IAsp

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.