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Clinical Trial Details

Trial ID: L2100
Source ID: NCT01676220
Associated Drug: Hoe901-U300 (New Formulation Of Insulin Glargine)
Title: Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy
Acronym: EDITION III
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01676220/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: HOE901-U300 (new formulation of insulin glargine)|DRUG: Lantus (insulin glargine)
Outcome Measures: Primary: Change in HbA1c From Baseline to Month 6 Endpoint, Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows., Baseline, Month 6 | Secondary: Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6, Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (\<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter \[mg/dL\]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively., Week 9 Up to Month 6|Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint, Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows., Baseline, Month 6|Variability of Preinjection SMPG at Month 6 Endpoint, Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows., Month 6|Percentage of Participants With HbA1c <7% at Month 6, Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit., Month 6|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint, Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows., Baseline, Month 6|Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6, Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit., Month 6|Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6, Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit., Baseline, Month 6|Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint, Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows., Baseline, Month 6|Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint, Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows., Baseline, Month 6|Change in Daily Basal Insulin Dose From Baseline to Month 6, Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit., Baseline, Month 6|Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint, DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows., Baseline, Month 6|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12, Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of \<=3.9 mmol/L \[70 mg/dL\]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level \<=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level \<=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level \>3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose \<=3.9 mmol/L)., Up to 12 months
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 878
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-08
Completion Date: 2014-03
Results First Posted: 2015-04-23
Last Update Posted: 2015-06-24
Locations: Investigational Site Number 840324, Montgomery, Alabama, 36109, United States|Investigational Site Number 840273, Chandler, Arizona, 85224, United States|Investigational Site Number 840217, Mesa, Arizona, 85206, United States|Investigational Site Number 840220, Peoria, Arizona, 85050, United States|Investigational Site Number 840211, Phoenix, Arizona, 85028, United States|Investigational Site Number 840207, Phoenix, Arizona, 85050, United States|Investigational Site Number 840264, Tempe, Arizona, 85282, United States|Investigational Site Number 840234, Tempe, Arizona, United States|Investigational Site Number 840304, Little Rock, Arkansas, 72205, United States|Investigational Site Number 840347, Bell Gardens, California, 90201, United States|Investigational Site Number 840244, Escondido, California, 92025, United States|Investigational Site Number 840257, Fresno, California, 93720, United States|Investigational Site Number 840213, Greenbrae, California, 94904, United States|Investigational Site Number 840267, Huntington Beach, California, 92648, United States|Investigational Site Number 840230, La Jolla, California, 92037, United States|Investigational Site Number 840235, La Mesa, California, 91942, United States|Investigational Site Number 840274, La Mesa, California, 91942, United States|Investigational Site Number 840222, Long Beach, California, 90806, United States|Investigational Site Number 840243, Palm Springs, California, 92262, United States|Investigational Site Number 840250, Spring Valley, California, 91978, United States|Investigational Site Number 840209, Temecula, California, 92591, United States|Investigational Site Number 840297, Torrance, California, 90502, United States|Investigational Site Number 840272, Tustin, California, 92780, United States|Investigational Site Number 840223, Walnut Creek, California, 94598, United States|Investigational Site Number 840249, Colorado Springs, Colorado, 80907, United States|Investigational Site Number 840331, Denver, Colorado, 80212, United States|Investigational Site Number 840299, Boca Raton, Florida, 33432, United States|Investigational Site Number 840285, Boynton Beach, Florida, 33472, United States|Investigational Site Number 840221, Bradenton, Florida, 34208, United States|Investigational Site Number 840233, Clearwater, Florida, 33765, United States|Investigational Site Number 840212, Coral Gables, Florida, 33134, United States|Investigational Site Number 840266, Coral Gables, Florida, 33134, United States|Investigational Site Number 840204, Hialeah, Florida, 33012, United States|Investigational Site Number 840248, Hollywood, Florida, 33021, United States|Investigational Site Number 840226, Jacksonville, Florida, 32205, United States|Investigational Site Number 840318, Jacksonville, Florida, 32216, United States|Investigational Site Number 840224, Jacksonville, Florida, 32258, United States|Investigational Site Number 840337, Miami Beach, Florida, 33141, United States|Investigational Site Number 840228, Miami, Florida, 33144, United States|Investigational Site Number 840238, Miami, Florida, 33144, United States|Investigational Site Number 840302, Miami, Florida, 33176, United States|Investigational Site Number 840227, New Port Richey, Florida, 34652, United States|Investigational Site Number 840303, North Miami Beach, Florida, 33162, United States|Investigational Site Number 840225, Ocala, Florida, 34471, United States|Investigational Site Number 840291, Orlando, Florida, 32804, United States|Investigational Site Number 840316, Orlando, Florida, 32806, United States|Investigational Site Number 840216, Oviedo, Florida, 32765, United States|Investigational Site Number 840332, Palm Harbor, Florida, 34684, United States|Investigational Site Number 840288, Pembroke Pines, Florida, 33028, United States|Investigational Site Number 840325, Port Charlotte, Florida, 33952, United States|Investigational Site Number 840309, St. Petersburg, Florida, 33716, United States|Investigational Site Number 840251, Tampa, Florida, 33603, United States|Investigational Site Number 840339, West Palm Beach, Florida, 33401, United States|Investigational Site Number 840245, Atlanta, Georgia, 30308, United States|Investigational Site Number 840323, Stockbridge, Georgia, 30281, United States|Investigational Site Number 840236, Honolulu, Hawaii, 96814, United States|Investigational Site Number 840283, Idaho Falls, Idaho, 83404, United States|Investigational Site Number 840278, Chicago, Illinois, 60607, United States|Investigational Site Number 840320, Chicago, Illinois, 60612, United States|Investigational Site Number 840276, Springfield, Illinois, 62704, United States|Investigational Site Number 840314, Avon, Indiana, 46123, United States|Investigational Site Number 840317, Avon, Indiana, 46123, United States|Investigational Site Number 840214, Des Moines, Iowa, 50314, United States|Investigational Site Number 840232, Overland Park, Kansas, 66210, United States|Investigational Site Number 840287, Topeka, Kansas, 66606, United States|Investigational Site Number 840344, Lexington, Kentucky, 40503, United States|Investigational Site Number 840231, Murray, Kentucky, 42003, United States|Investigational Site Number 840348, Metairie, Louisiana, 70006, United States|Investigational Site Number 840290, New Orleans, Louisiana, 70119, United States|Investigational Site Number 840208, Baltimore, Maryland, 21237, United States|Investigational Site Number 840301, Rockville, Maryland, 20852, United States|Investigational Site Number 840289, Fall River, Massachusetts, 02720, United States|Investigational Site Number 840253, Haverhill, Massachusetts, 1830, United States|Investigational Site Number 840270, Madison Heights, Michigan, 48071, United States|Investigational Site Number 840300, Omaha, Nebraska, 68105, United States|Investigational Site Number 840210, Omaha, Nebraska, 68131, United States|Investigational Site Number 840263, Omaha, Nebraska, 68131, United States|Investigational Site Number 840349, Las Vegas, Nevada, 89117, United States|Investigational Site Number 840201, Las Vegas, Nevada, 89119, United States|Investigational Site Number 840256, Las Vegas, Nevada, 89148, United States|Investigational Site Number 840306, Hamilton, New Jersey, 08619, United States|Investigational Site Number 840203, Sea Girt, New Jersey, 08750, United States|Investigational Site Number 840295, Sicklerville, New Jersey, 08081, United States|Investigational Site Number 840269, Albuquerque, New Mexico, 87106, United States|Investigational Site Number 840310, New Hyde Park, New York, 11042, United States|Investigational Site Number 840247, Asheville, North Carolina, 28803, United States|Investigational Site Number 840296, Greensboro, North Carolina, 27408, United States|Investigational Site Number 840275, Morganton, North Carolina, 28655, United States|Investigational Site Number 840330, Cleveland, Ohio, 44122, United States|Investigational Site Number 840307, Columbus, Ohio, 43213, United States|Investigational Site Number 840229, Norman, Oklahoma, 73069, United States|Investigational Site Number 840219, Bend, Oregon, 97701, United States|Investigational Site Number 840240, Philadelphia, Pennsylvania, 19139, United States|Investigational Site Number 840308, Tipton, Pennsylvania, 16684, United States|Investigational Site Number 840252, Greer, South Carolina, 29651, United States|Investigational Site Number 840237, Spartanburg, South Carolina, 29303, United States|Investigational Site Number 840294, Dakota Dunes, South Dakota, 57049, United States|Investigational Site Number 840260, Bristol, Tennessee, 37620, United States|Investigational Site Number 840262, Chattanooga, Tennessee, 37404, United States|Investigational Site Number 840342, Corpus Christi, Texas, 78404, United States|Investigational Site Number 840268, Dallas, Texas, 75230, United States|Investigational Site Number 840292, Dallas, Texas, 75230, United States|Investigational Site Number 840315, Dallas, Texas, 75231, United States|Investigational Site Number 840242, Dallas, Texas, 75246, United States|Investigational Site Number 840326, Edinburg, Texas, 78539, United States|Investigational Site Number 840338, Houston, Texas, 77002, United States|Investigational Site Number 840218, Houston, Texas, 77004, United States|Investigational Site Number 840328, Houston, Texas, 77074, United States|Investigational Site Number 840259, Houston, Texas, 77095, United States|Investigational Site Number 840327, Pearland, Texas, 77584, United States|Investigational Site Number 840282, San Antonio, Texas, 78229, United States|Investigational Site Number 840202, Murray, Utah, 84123, United States|Investigational Site Number 840343, Salt Lake City, Utah, 84107, United States|Investigational Site Number 840239, Burke, Virginia, 22015, United States|Investigational Site Number 840206, Manassas, Virginia, 20110, United States|Investigational Site Number 840246, Renton, Washington, 98055, United States|Investigational Site Number 840311, Milwaukee, Wisconsin, 53209-0996, United States|Investigational Site Number 100205, Blagoevgrad, 2700, Bulgaria|Investigational Site Number 100203, Byala, 7100, Bulgaria|Investigational Site Number 100201, Plovdiv, 4002, Bulgaria|Investigational Site Number 100204, Plovdiv, 4002, Bulgaria|Investigational Site Number 100206, Sofia, 1431, Bulgaria|Investigational Site Number 124204, Brampton, L6R 3J5, Canada|Investigational Site Number 124211, Etobicoke, M9R 4E1, Canada|Investigational Site Number 124208, Laval, H7T 2P5, Canada|Investigational Site Number 124214, London, N6A 5G6, Canada|Investigational Site Number 124210, Montreal, H1Y 3L1, Canada|Investigational Site Number 124218, Montreal, H4N 3C5, Canada|Investigational Site Number 124206, Pointe-Claire, H9R 4S3, Canada|Investigational Site Number 124219, Sherbrooke, J1H 1Z1, Canada|Investigational Site Number 124201, Thornhill, L4J 8L7, Canada|Investigational Site Number 124209, Thornhill, L4J 8L7, Canada|Investigational Site Number 124212, Toronto, M9W 4L9, Canada|Investigational Site Number 124216, Ville St-Laurent, H4T 1Z9, Canada|Investigational Site Number 203201, Brno, 62500, Czech Republic|Investigational Site Number 203205, Brno, 65691, Czech Republic|Investigational Site Number 203204, Havirov, 73601, Czech Republic|Investigational Site Number 203203, Praha 10, 10034, Czech Republic|Investigational Site Number 203202, Praha 8, 18100, Czech Republic|Investigational Site Number 208203, Esbjerg, 6700, Denmark|Investigational Site Number 208209, Hellerup, 2900, Denmark|Investigational Site Number 208202, Herlev, 2730, Denmark|Investigational Site Number 208206, Hvidovre, 2650, Denmark|Investigational Site Number 208210, Kolding, 6000, Denmark|Investigational Site Number 208207, København Nv, 2400, Denmark|Investigational Site Number 208201, Odense C, 5000, Denmark|Investigational Site Number 208204, Viborg, 8800, Denmark|Investigational Site Number 208205, Ålborg, 9100, Denmark|Investigational Site Number 233204, Tallinn, 13419, Estonia|Investigational Site Number 233203, Tartu, 50406, Estonia|Investigational Site Number 233205, Tartu, 50410, Estonia|Investigational Site Number 246208, Helsinki, 260, Finland|Investigational Site Number 246202, Kokkola, 67100, Finland|Investigational Site Number 246207, Oulu, 90100, Finland|Investigational Site Number 246206, Tampere, 33100, Finland|Investigational Site Number 246205, Turku, 20100, Finland|Investigational Site Number 348205, Balassagyarmat, 2660, Hungary|Investigational Site Number 348201, Budapest, 1036, Hungary|Investigational Site Number 348207, Budapest, 1036, Hungary|Investigational Site Number 348212, Budapest, 1083, Hungary|Investigational Site Number 348210, Budapest, 1134, Hungary|Investigational Site Number 348202, Urhida, 8142, Hungary|Investigational Site Number 392214, Fujimi, Japan|Investigational Site Number 392215, Fujimi, Japan|Investigational Site Number 392206, Ise-Shi, Japan|Investigational Site Number 392217, Kitaazumi-Gun, Japan|Investigational Site Number 392210, Matsumoto-Shi, Japan|Investigational Site Number 392208, Matumoto, Japan|Investigational Site Number 392205, Midori-Shi, Japan|Investigational Site Number 392203, Mito-Shi, Japan|Investigational Site Number 392216, Sakai, Japan|Investigational Site Number 392213, Shimotsuke, Japan|Investigational Site Number 392218, Shunan-Shi, Japan|Investigational Site Number 392204, Yamagata-Shi, Japan|Investigational Site Number 428206, Riga, 1024, Latvia|Investigational Site Number 428203, Riga, LV-1002, Latvia|Investigational Site Number 428205, Riga, LV-1050, Latvia|Investigational Site Number 428202, Sigulda, LV-2150, Latvia|Investigational Site Number 428201, Ventspils, LV-3601, Latvia|Investigational Site Number 440203, Kaunas, 48259, Lithuania|Investigational Site Number 440204, Kaunas, LT-49456, Lithuania|Investigational Site Number 440201, Klaipeda, LT-92253, Lithuania|Investigational Site Number 440202, Klaipeda, LT-92304, Lithuania|Investigational Site Number 440205, Vilnius, LT-08661, Lithuania|Investigational Site Number 528204, Almere, 1311 RL, Netherlands|Investigational Site Number 528209, Beek, 6191 JW, Netherlands|Investigational Site Number 528205, Breda, 4811 SW, Netherlands|Investigational Site Number 528207, Leiderdorp, 2352 RA, Netherlands|Investigational Site Number 528203, Rotterdam, 3021 HC, Netherlands|Investigational Site Number 528202, Velp, 6883 ES, Netherlands|Investigational Site Number 840709, Cagua, 725, Puerto Rico|Investigational Site Number 840706, Carolina, 987, Puerto Rico|Investigational Site Number 840704, San Juan, 00917, Puerto Rico|Investigational Site Number 840710, San Juan, 00917, Puerto Rico|Investigational Site Number 840703, San Juan, 917, Puerto Rico|Investigational Site Number 840708, San Juan, 926, Puerto Rico|Investigational Site Number 642208, Bacau, 600164, Romania|Investigational Site Number 642212, Bucuresti, 020359, Romania|Investigational Site Number 642201, Bucuresti, 20475, Romania|Investigational Site Number 642202, Cluj-Napoca, 400006, Romania|Investigational Site Number 642213, Oradea, 410169, Romania|Investigational Site Number 642207, Resita, 320076, Romania|Investigational Site Number 642205, Sibiu, 550371, Romania|Investigational Site Number 642203, Targu Mures, 540142, Romania|Investigational Site Number 642204, Targu Mures, 540142, Romania|Investigational Site Number 642206, Timisoara, 300133, Romania|Investigational Site Number 642209, Timisoara, 300456, Romania|Investigational Site Number 703205, Banska Bystrica, 97517, Slovakia|Investigational Site Number 703202, Bardejov, 085 01, Slovakia|Investigational Site Number 703203, Bratislava, 85101, Slovakia|Investigational Site Number 703201, Levice, 93405, Slovakia|Investigational Site Number 703206, Levice, 95401, Slovakia|Investigational Site Number 703207, Lucenec, 98401, Slovakia|Investigational Site Number 752205, Kristianstad, 29185, Sweden|Investigational Site Number 752206, Malmö, 211 52, Sweden|Investigational Site Number 752201, Stockholm, 11526, Sweden|Investigational Site Number 752204, Vällingby, 16268, Sweden
URL: https://clinicaltrials.gov/show/NCT01676220

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress