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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

NCT ID: NCT02034513

Last Updated: 2019-01-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

501 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-05

Study Completion Date

2016-01-11

Brief Summary

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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.

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A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IDeg OD + IAsp followed by IGlar OD + IAsp

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

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

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

insulin glargine

Intervention Type DRUG

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

insulin aspart

Intervention Type DRUG

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

IGlar OD + IAsp followed by IDeg OD + IAsp

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

Group Type ACTIVE_COMPARATOR

insulin degludec

Intervention Type DRUG

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

insulin glargine

Intervention Type DRUG

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

insulin aspart

Intervention Type DRUG

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

Interventions

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insulin degludec

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

Intervention Type DRUG

insulin glargine

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

Intervention Type DRUG

insulin aspart

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Subjects fulfilling at least one of the below criteria: a) Experienced at least one severe hypo episode within the last year (according to the ADA (American Diabetes Association) definition, April 2013) b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m\^2 per CKD-Epi (chronic kidney disease epidemiology collaboration) c) Hypoglycaemic symptom unawareness d) Diabetes mellitus duration for more than 15 years e) Recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dL \[below or equal to 3.

Exclusion Criteria

9 mmol/L\])) within the last 12 weeks prior to Visit 1 (screening) - Male or female, age at least 18 years at the time of signing informed consent - Type 1 diabetes mellitus (diagnosed clinically) for at least 52 weeks prior to Visit 1 - Current treatment with a basal-bolus regimen consisting of neutral protamine Hagedorn (NPH) insulin OD (once daily) / BID (twice daily) or insulin detemir (IDet) OD / BID plus 2-4 daily injections of any rapid acting meal time insulin or CSII (with rapid acting insulin) for at least 26 weeks prior to Visit 1 - HbA1c (glycosylated haemoglobin) below or equal to 10% by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m\^2 Exclusion Criteria: - Treatment with IGlar or IDeg within the last 26 weeks prior to Visit 1 (short term use \[less than or equal to 2 weeks\] is allowed, but not within 4 weeks prior to screening) - Use of any other anti-diabetic agent than those stated in the inclusion criteria within the last 26 weeks prior to Visit 1
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Birmingham, Alabama, United States

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Goodyear, Arizona, United States

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Concord, California, United States

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Escondido, California, United States

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Fresno, California, United States

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La Jolla, California, United States

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Long Beach, California, United States

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Rancho Cucamonga, California, United States

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San Mateo, California, United States

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San Ramon, California, United States

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Santa Monica, California, United States

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Upland, California, United States

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Ventura, California, United States

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Denver, Colorado, United States

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Cooper City, Florida, United States

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Fleming Island, Florida, United States

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Fort Lauderdale, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Springs, Florida, United States

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New Port Richey, Florida, United States

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Pembroke Pines, Florida, United States

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Port Charlotte, Florida, United States

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Port Orange, Florida, United States

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Lawrenceville, Georgia, United States

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Idaho Falls, Idaho, United States

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Arlington Heights, Illinois, United States

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Chicago, Illinois, United States

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Crystal Lake, Illinois, United States

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Skokie, Illinois, United States

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Anderson, Indiana, United States

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Indianapolis, Indiana, United States

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Council Bluffs, Iowa, United States

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West Des Moines, Iowa, United States

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Lenexa, Kansas, United States

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Topeka, Kansas, United States

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Lexington, Kentucky, United States

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Livonia, Michigan, United States

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Hazelwood, Missouri, United States

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Jefferson City, Missouri, United States

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Kansas City, Missouri, United States

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Billings, Montana, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Nashua, New Hampshire, United States

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Hamilton, New Jersey, United States

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Albany, New York, United States

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Harrison, New York, United States

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Mineola, New York, United States

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Syracuse, New York, United States

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Asheville, North Carolina, United States

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Greenville, North Carolina, United States

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Morehead City, North Carolina, United States

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Raleigh, North Carolina, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Jenkintown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Chattanooga, Tennessee, United States

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Kingsport, Tennessee, United States

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Amarillo, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Carrollton, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Katy, Texas, United States

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Mesquite, Texas, United States

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Richardson, Texas, United States

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San Antonio, Texas, United States

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Schertz, Texas, United States

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Sugar Land, Texas, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Chesapeake, Virginia, United States

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Norfolk, Virginia, United States

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Federal Way, Washington, United States

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Renton, Washington, United States

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Richland, Washington, United States

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Spokane, Washington, United States

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Walla Walla, Washington, United States

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Milwaukee, Wisconsin, United States

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Bialystok, , Poland

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Gdansk, , Poland

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Gdansk, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Zabrze, , Poland

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Manatí, , Puerto Rico

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Countries

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United States Poland Puerto Rico

References

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Lane W, Bailey TS, Gerety G, Gumprecht J, Philis-Tsimikas A, Hansen CT, Nielsen TSS, Warren M; Group Information; SWITCH 1. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial. JAMA. 2017 Jul 4;318(1):33-44. doi: 10.1001/jama.2017.7115.

Reference Type RESULT
PMID: 28672316 (View on PubMed)

Evans M, Mehta R, Gundgaard J, Chubb B. Cost-Effectiveness of Insulin Degludec vs. Insulin Glargine U100 in Type 1 and Type 2 Diabetes Mellitus in a UK Setting. Diabetes Ther. 2018 Oct;9(5):1919-1930. doi: 10.1007/s13300-018-0478-1. Epub 2018 Aug 10.

Reference Type RESULT
PMID: 30097995 (View on PubMed)

DeVries JH, Bailey TS, Bhargava A, Gerety G, Gumprecht J, Heller S, Lane W, Wysham CH, Zinman B, Bak BA, Hachmann-Nielsen E, Philis-Tsimikas A. Day-to-day fasting self-monitored blood glucose variability is associated with risk of hypoglycaemia in insulin-treated patients with type 1 and type 2 diabetes: A post hoc analysis of the SWITCH Trials. Diabetes Obes Metab. 2019 Mar;21(3):622-630. doi: 10.1111/dom.13565. Epub 2018 Nov 26.

Reference Type RESULT
PMID: 30362250 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1129-9668

Identifier Type: OTHER

Identifier Source: secondary_id

2012-001930-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN1250-3995

Identifier Type: -

Identifier Source: org_study_id

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