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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

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2

Intervention: insulin degludec (Drug); insulin glargine (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S

Summary

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.

Clinical Details

Official title: A Randomised, Double Blind, Cross-over Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes (SWITCH 2)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period

Secondary outcome:

Number of treatment emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic during the maintenance period

Proportion of subjects with one or more severe hypoglycaemic episodes during the maintenance period

Incidence of treatment emergent adverse events

Change from baseline in HbA1c (glycosylated haemoglobin)

FPG (fasting plasma glucose)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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. 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

Locations and Contacts

Novo Nordisk Clinical Trial Call Center, Carolina 00983, Puerto Rico

Novo Nordisk Clinical Trial Call Center, Manati 00674, Puerto Rico

Novo Nordisk Clinical Trial Call Center, Ponce 00717, Puerto Rico

Novo Nordisk Clinical Trial Call Center, San Juan 00918, Puerto Rico

Novo Nordisk Clinical Trial Call Center, San Juan 00921, Puerto Rico

Novo Nordisk Clinical Trial Call Center, Birmingham, Alabama 35215-7502, United States

Novo Nordisk Clinical Trial Call Center, Birmingham, Alabama 35216, United States

Novo Nordisk Clinical Trial Call Center, Haleyville, Alabama 35565-1719, United States

Novo Nordisk Clinical Trial Call Center, Montgomery, Alabama 36106, United States

Novo Nordisk Clinical Trial Call Center, Phoenix, Arizona 85013, United States

Novo Nordisk Clinical Trial Call Center, Phoenix, Arizona 85050, United States

Novo Nordisk Clinical Trial Call Center, Little Rock, Arkansas 72205, United States

Novo Nordisk Clinical Trial Call Center, Chino, California 91710, United States

Novo Nordisk Clinical Trial Call Center, Costa Mesa, California 92626, United States

Novo Nordisk Clinical Trial Call Center, Downey, California 90242, United States

Novo Nordisk Clinical Trial Call Center, El Cajon, California 92020, United States

Novo Nordisk Clinical Trial Call Center, Fresno, California 93720, United States

Novo Nordisk Clinical Trial Call Center, Fresno, California 93702, United States

Novo Nordisk Clinical Trial Call Center, Hawaiian Gardens, California 90716, United States

Novo Nordisk Clinical Trial Call Center, Huntington Park, California 90255, United States

Novo Nordisk Clinical Trial Call Center, Lincoln, California 95648, United States

Novo Nordisk Clinical Trial Call Center, Long Beach, California 90807, United States

Novo Nordisk Clinical Trial Call Center, Northridge, California 91325, United States

Novo Nordisk Clinical Trial Call Center, Pomona, California 91766-1854, United States

Novo Nordisk Clinical Trial Call Center, Rancho Cucamonga, California 91730-3063, United States

Novo Nordisk Clinical Trial Call Center, Rialto, California 92376, United States

Novo Nordisk Clinical Trial Call Center, Roseville, California 95661, United States

Novo Nordisk Clinical Trial Call Center, San Diego, California 92111, United States

Novo Nordisk Clinical Trial Call Center, Santa Monica, California 90404, United States

Novo Nordisk Clinical Trial Call Center, Tarzana, California 91356-3551, United States

Novo Nordisk Clinical Trial Call Center, Tustin, California 92780, United States

Novo Nordisk Clinical Trial Call Center, Golden, Colorado 80401, United States

Novo Nordisk Clinical Trial Call Center, Bradenton, Florida 34208, United States

Novo Nordisk Clinical Trial Call Center, Chiefland, Florida 32626, United States

Novo Nordisk Clinical Trial Call Center, Clearwater, Florida 33756, United States

Novo Nordisk Clinical Trial Call Center, Clearwater, Florida 33765, United States

Novo Nordisk Clinical Trial Call Center, Cooper City, Florida 33024, United States

Novo Nordisk Clinical Trial Call Center, Doral, Florida 33165, United States

Novo Nordisk Clinical Trial Call Center, Doral, Florida 33166, United States

Novo Nordisk Clinical Trial Call Center, Hialeah, Florida 33012, United States

Novo Nordisk Clinical Trial Call Center, Hialeah, Florida 33013, United States

Novo Nordisk Clinical Trial Call Center, Jacksonville, Florida 32256, United States

Novo Nordisk Clinical Trial Call Center, Jacksonville, Florida 32216, United States

Novo Nordisk Clinical Trial Call Center, Jacksonville, Florida 32277, United States

Novo Nordisk Clinical Trial Call Center, Jacksonville, Florida 32204, United States

Novo Nordisk Clinical Trial Call Center, Miami Springs, Florida 33166, United States

Novo Nordisk Clinical Trial Call Center, Miami, Florida 33186, United States

Novo Nordisk Clinical Trial Call Center, Miami, Florida 33130, United States

Novo Nordisk Clinical Trial Call Center, Miami, Florida 33155, United States

Novo Nordisk Clinical Trial Call Center, Miami, Florida 33156, United States

Novo Nordisk Clinical Trial Call Center, Miami, Florida 33174, United States

Novo Nordisk Clinical Trial Call Center, Miami, Florida 33175, United States

Novo Nordisk Clinical Trial Call Center, Miramar, Florida 33027, United States

Novo Nordisk Clinical Trial Call Center, New Port Richey, Florida 34652, United States

Novo Nordisk Clinical Trial Call Center, Ocala, Florida 34471, United States

Novo Nordisk Clinical Trial Call Center, Orlando, Florida 32801, United States

Novo Nordisk Clinical Trial Call Center, Panama City, Florida 32401, United States

Novo Nordisk Clinical Trial Call Center, Pembroke Pines, Florida 33026, United States

Novo Nordisk Clinical Trial Call Center, Tampa, Florida 33607, United States

Novo Nordisk Clinical Trial Call Center, Tampa, Florida 33619, United States

Novo Nordisk Clinical Trial Call Center, Perry, Georgia 31069, United States

Novo Nordisk Clinical Trial Call Center, Champaign, Illinois 61821, United States

Novo Nordisk Clinical Trial Call Center, Chicago, Illinois 60611, United States

Novo Nordisk Clinical Trial Call Center, Evansville, Indiana 47714, United States

Novo Nordisk Clinical Trial Call Center, Muncie, Indiana 47304, United States

Novo Nordisk Clinical Trial Call Center, Des Moines, Iowa 50314-2610, United States

Novo Nordisk Clinical Trial Call Center, Lenexa, Kansas 66219, United States

Novo Nordisk Clinical Trial Call Center, Newton, Kansas 67114, United States

Novo Nordisk Clinical Trial Call Center, Lexington, Kentucky 40502, United States

Novo Nordisk Clinical Trial Call Center, Lexington, Kentucky 40503, United States

Novo Nordisk Clinical Trial Call Center, Louisville, Kentucky 40218, United States

Novo Nordisk Clinical Trial Call Center, Paducah, Kentucky 42003, United States

Novo Nordisk Clinical Trial Call Center, New Orleans, Louisiana 70119, United States

Novo Nordisk Clinical Trial Call Center, Brockton, Massachusetts 02301, United States

Novo Nordisk Clinical Trial Call Center, Kalamazoo, Michigan 49009, United States

Novo Nordisk Clinical Trial Call Center, Olive Branch, Mississippi 38654-3573, United States

Novo Nordisk Clinical Trial Call Center, Florissant, Missouri 63031, United States

Novo Nordisk Clinical Trial Call Center, Jefferson City, Missouri 65109, United States

Novo Nordisk Clinical Trial Call Center, Henderson, Nevada 89052-2649, United States

Novo Nordisk Clinical Trial Call Center, Las Vegas, Nevada 89128, United States

Novo Nordisk Clinical Trial Call Center, Morganville, New Jersey 07751, United States

Novo Nordisk Clinical Trial Call Center, Teaneck, New Jersey 07666, United States

Novo Nordisk Clinical Trial Call Center, Albuquerque, New Mexico 87102, United States

Novo Nordisk Clinical Trial Call Center, Albany, New York 12208, United States

Novo Nordisk Clinical Trial Call Center, Jackson Heights, New York 11372, United States

Novo Nordisk Clinical Trial Call Center, New Windsor, New York 12553, United States

Novo Nordisk Clinical Trial Call Center, Northport, New York 11768, United States

Novo Nordisk Clinical Trial Call Center, Smithtown, New York 11787, United States

Novo Nordisk Clinical Trial Call Center, Charlotte, North Carolina 28277, United States

Novo Nordisk Clinical Trial Call Center, Delaware, Ohio 43015, United States

Novo Nordisk Clinical Trial Call Center, Franklin, Ohio 45005, United States

Novo Nordisk Clinical Trial Call Center, Toledo, Ohio 43614, United States

Novo Nordisk Clinical Trial Call Center, Oklahoma City, Oklahoma 73103, United States

Novo Nordisk Clinical Trial Call Center, Beaver, Pennsylvania 15009, United States

Novo Nordisk Clinical Trial Call Center, Philadelphia, Pennsylvania 19107, United States

Novo Nordisk Clinical Trial Call Center, Philadelphia, Pennsylvania 19152, United States

Novo Nordisk Clinical Trial Call Center, Scottdale, Pennsylvania 15683, United States

Novo Nordisk Clinical Trial Call Center, Tipton, Pennsylvania 16684, United States

Novo Nordisk Clinical Trial Call Center, Gaffney, South Carolina 29341, United States

Novo Nordisk Clinical Trial Call Center, Greenville, South Carolina 29615, United States

Novo Nordisk Clinical Trial Call Center, Pelzer, South Carolina 29669, United States

Novo Nordisk Clinical Trial Call Center, Rapid City, South Dakota 57701, United States

Novo Nordisk Clinical Trial Call Center, Bristol, Tennessee 37620-7352, United States

Novo Nordisk Clinical Trial Call Center, Bristol, Tennessee 37620, United States

Novo Nordisk Clinical Trial Call Center, Chattanooga, Tennessee 37404, United States

Novo Nordisk Clinical Trial Call Center, Humboldt, Tennessee 38343, United States

Novo Nordisk Clinical Trial Call Center, Jackson, Tennessee 38305, United States

Novo Nordisk Clinical Trial Call Center, Johnson City, Tennessee 37604, United States

Novo Nordisk Clinical Trial Call Center, Kingsport, Tennessee 37660, United States

Novo Nordisk Clinical Trial Call Center, Arlington, Texas 76012-4637, United States

Novo Nordisk Clinical Trial Call Center, Arlington, Texas 76012, United States

Novo Nordisk Clinical Trial Call Center, Austin, Texas 78758, United States

Novo Nordisk Clinical Trial Call Center, Carrollton, Texas 75007, United States

Novo Nordisk Clinical Trial Call Center, Dallas, Texas 75208, United States

Novo Nordisk Clinical Trial Call Center, El Paso, Texas 79925, United States

Novo Nordisk Clinical Trial Call Center, Fort Worth, Texas 76104, United States

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77077, United States

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77036, United States

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77060, United States

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77070, United States

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77072, United States

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77043, United States

Novo Nordisk Clinical Trial Call Center, Humble, Texas 77338, United States

Novo Nordisk Clinical Trial Call Center, Hurst, Texas 76054, United States

Novo Nordisk Clinical Trial Call Center, Marshall, Texas 75670, United States

Novo Nordisk Clinical Trial Call Center, Mesquite, Texas 75149, United States

Novo Nordisk Clinical Trial Call Center, North Richland Hills, Texas 76180, United States

Novo Nordisk Clinical Trial Call Center, Plano, Texas 75075, United States

Novo Nordisk Clinical Trial Call Center, Plano, Texas 75093, United States

Novo Nordisk Clinical Trial Call Center, San Antonio, Texas 78215, United States

Novo Nordisk Clinical Trial Call Center, San Antonio, Texas 78224, United States

Novo Nordisk Clinical Trial Call Center, San Antonio, Texas 78228-3419, United States

Novo Nordisk Clinical Trial Call Center, San Antonio, Texas 78229, United States

Novo Nordisk Clinical Trial Call Center, San Antonio, Texas 78240, United States

Novo Nordisk Clinical Trial Call Center, San Antonio, Texas 78258, United States

Novo Nordisk Clinical Trial Call Center, Sugarland, Texas 77478, United States

Novo Nordisk Clinical Trial Call Center, Victoria, Texas 77901, United States

Novo Nordisk Clinical Trial Call Center, Waco, Texas 76710, United States

Novo Nordisk Clinical Trial Call Center, Draper, Utah 84020, United States

Novo Nordisk Clinical Trial Call Center, Ogden, Utah 84405, United States

Novo Nordisk Clinical Trial Call Center, Salt Lake City, Utah 84107, United States

Novo Nordisk Clinical Trial Call Center, Chesapeake, Virginia 23321, United States

Novo Nordisk Clinical Trial Call Center, Norfolk, Virginia 23510, United States

Novo Nordisk Clinical Trial Call Center, Olympia, Washington 98502, United States

Novo Nordisk Clinical Trial Call Center, Renton, Washington 98057, United States

Novo Nordisk Clinical Trial Call Center, Spokane, Washington 99202-3649, United States

Novo Nordisk Clinical Trial Call Center, Martinsburg, West Virginia 25401, United States

Novo Nordisk Clinical Trial Call Center, Kenosha, Wisconsin 53142, United States

Additional Information

Clinical Trials at Novo Nordisk

Starting date: January 2014
Last updated: July 29, 2015

Page last updated: August 23, 2015

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