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A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes

NCT ID: NCT02030600

Last Updated: 2019-05-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

721 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-06

Study Completion Date

2015-12-04

Brief Summary

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This trial is conducted in 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) with or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in subjects with type 2 diabetes.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

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 ± OADs followed by IGlar OD ± OADs

The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks.

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.

IGlar OD ± OADs followed by IDeg OD ± OADs

The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks.

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.

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

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects fulfilling at least one of the below criteria: a) Experienced at least one severe hypoglycaemic episode within 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) by central laboratory analysis, c) Hypoglycaemic symptom unawareness, d) Exposed to insulin for more than 5 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 \[below or equal to 3.9 mmol/L\])) within the last 12 weeks prior to Visit 1 (screening) - Type 2 diabetes mellitus (diagnosed clinically) for at least 26 weeks prior to Visit 1 - Current treatment with any basal insulin (OD or BID) ± any combination of OADs (metformin, DPP-4 inhibitor, alpha-glucosidase inhibitor, thiazolidinediones, and SGLT2-inhibitor) for 26 weeks or longer prior to Visit 1 For subjects on BID the total daily dose should be below 75 units - HbA1c (glycosylated haemoglobin) below or equal to 9.

Exclusion Criteria

5 % by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m\^2 Exclusion Criteria: - Treatment with a bolus insulin separately or contained in an insulin mix product within the last 26 weeks prior to Visit 1 - Use of any other anti-diabetic agent(s) 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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Birmingham, Alabama, United States

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Haleyville, Alabama, United States

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Montgomery, Alabama, United States

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Tuscumbia, Alabama, United States

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Chandler, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Costa Mesa, California, United States

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Downey, California, United States

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El Cajon, California, United States

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Fresno, California, United States

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Fresno, California, United States

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Hawaiian Gardens, California, United States

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Huntington Park, California, United States

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Lincoln, California, United States

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Long Beach, California, United States

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Montclair, California, United States

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North Hollywood, California, United States

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Northridge, California, United States

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Pomona, California, United States

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Poway, California, United States

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Rancho Cucamonga, California, United States

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Rialto, California, United States

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Roseville, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Tarzana, California, United States

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Torrance, California, United States

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Tustin, California, United States

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Colorado Springs, Colorado, United States

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Golden, Colorado, United States

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Newark, Delaware, United States

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Bradenton, Florida, United States

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Chiefland, Florida, United States

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Clearwater, Florida, United States

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Clearwater, Florida, United States

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Cooper City, Florida, United States

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Doral, Florida, United States

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Hialeah, 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, 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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Miramar, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Panama City, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Perry, Georgia, United States

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Champaign, Illinois, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Muncie, Indiana, United States

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West Des Moines, Iowa, United States

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Lenexa, Kansas, United States

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Newton, Kansas, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Paducah, Kentucky, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Brockton, Massachusetts, United States

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Kalamazoo, Michigan, United States

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Olive Branch, Mississippi, United States

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Florissant, 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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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Newington, New Hampshire, United States

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Morganville, New Jersey, United States

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Teaneck, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Jackson Heights, New York, United States

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New Windsor, New York, United States

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Northport, New York, United States

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Smithtown, New York, United States

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Charlotte, North Carolina, United States

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Morganton, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Delaware, Ohio, United States

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Franklin, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Altoona, Pennsylvania, United States

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Beaver, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Scottdale, Pennsylvania, United States

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Anderson, South Carolina, United States

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Gaffney, South Carolina, United States

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Greer, South Carolina, United States

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Pelzer, South Carolina, United States

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Spartanburg, South Carolina, United States

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Rapid City, South Dakota, United States

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Bristol, Tennessee, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Humboldt, Tennessee, United States

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Jackson, Tennessee, United States

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Johnson City, Tennessee, United States

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Kingsport, Tennessee, United States

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Arlington, Texas, United States

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Arlington, 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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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Humble, Texas, United States

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Hurst, Texas, United States

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Marshall, Texas, United States

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Mesquite, Texas, United States

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North Richland Hills, Texas, United States

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Plano, Texas, United States

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Plano, Texas, United States

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Richardson, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Sealy, Texas, United States

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Sugar Land, Texas, United States

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Sugar Land, Texas, United States

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Victoria, Texas, United States

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Waco, Texas, United States

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Draper, Utah, United States

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Ogden, 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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Olympia, 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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Martinsburg, West Virginia, United States

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Kenosha, Wisconsin, United States

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Carolina, , Puerto Rico

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Manatí, , Puerto Rico

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Ponce, , Puerto Rico

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San Juan, , Puerto Rico

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San Juan, , Puerto Rico

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Countries

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United States Puerto Rico

References

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Chaykin L, Bhargava A, de la Rosa R, Wysham CH, Norgard Troelsen L, Ostoft SH, Philis-Tsimikas A. Effect of Insulin Degludec Versus Insulin Glargine U100 on Hypoglycemia in Hispanic Patients With Type 2 Diabetes: Results From the SWITCH 2 Trial. Clin Diabetes. 2019 Jan;37(1):73-81. doi: 10.2337/cd18-0016.

Reference Type BACKGROUND
PMID: 30705500 (View on PubMed)

Wysham C, Bhargava A, Chaykin L, de la Rosa R, Handelsman Y, Troelsen LN, Kvist K, Norwood P. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes: The SWITCH 2 Randomized Clinical Trial. JAMA. 2017 Jul 4;318(1):45-56. doi: 10.1001/jama.2017.7117.

Reference Type RESULT
PMID: 28672317 (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)

Heller SR, DeVries JH, Wysham C, Hansen CT, Hansen MV, Frier BM. Lower rates of hypoglycaemia in older individuals with type 2 diabetes using insulin degludec versus insulin glargine U100: Results from SWITCH 2. Diabetes Obes Metab. 2019 Jul;21(7):1634-1641. doi: 10.1111/dom.13708. Epub 2019 Apr 15.

Reference Type RESULT
PMID: 30891886 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1143-7963

Identifier Type: OTHER

Identifier Source: secondary_id

NN1250-3998

Identifier Type: -

Identifier Source: org_study_id

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