Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy

NCT01676220 | Completed Phase 3 Results

• 3 other identifiers: EFC123472012-000146-35U1111-1124-5261
• Study Type: interventional
• Target: 878
• Locations: 16 countries
• Sites: 217

Brief Summary

Primary Objective: To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus Secondary Objectives: To compare a new formulation of insulin glargine and Lantus in terms of: \- occurrence of nocturnal hypoglycemia

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6

  Week 9 Up to Month 6

• Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint

  Baseline, Month 6

• Variability of Preinjection SMPG at Month 6 Endpoint

  Month 6

• Percentage of Participants With HbA1c <7% at Month 6

  Month 6

• Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint

  Baseline, Month 6

Study Arms (2)

HOE901-U300

EXPERIMENTAL

Drug: HOE901-U300 (new formulation of insulin glargine)

Lantus

ACTIVE COMPARATOR

Drug: Lantus (insulin glargine)

Interventions

HOE901-U300 (new formulation of insulin glargine) DRUG

HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]).

HOE901-U300

Lantus (insulin glargine) DRUG

Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

Also known as: Lantus

Lantus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s);
• Signed written informed consent.

You may not qualify if:

• HbA1c less than (\<) 7.0% (\< 53 millimole per mole \[mmol/mol\]) or greater than (\>) 11% (\> 97 mmol/mol)
• History of type 2 diabetes mellitus for less than 1 year before screening
• Less than 6 months before screening with non-insulin antihyperglycemic treatment
• Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening
• Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of Glucagon-like peptide-1 (GLP-1) receptor agonist in the last 6 months before screening visit
• Participants receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinide (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin, sulfonylurea and glinide are to be discontinued at baseline)
• Current or previous insulin use except for a maximum of 8 consecutive days (for example, acute illness, surgery) during the last year prior to screening
• Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (for example, laser, surgical treatment or injectable drugs) during the study period
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (217)

Investigational Site Number 840324

Montgomery, Alabama, 36109, United States

Location

Investigational Site Number 840273

Chandler, Arizona, 85224, United States

Location

Investigational Site Number 840217

Mesa, Arizona, 85206, United States

Location

Investigational Site Number 840220

Peoria, Arizona, 85050, United States

Location

Investigational Site Number 840211

Phoenix, Arizona, 85028, United States

Location

Investigational Site Number 840207

Phoenix, Arizona, 85050, United States

Location

Investigational Site Number 840264

Tempe, Arizona, 85282, United States

Location

Investigational Site Number 840234

Tempe, Arizona, United States

Location

Investigational Site Number 840304

Little Rock, Arkansas, 72205, United States

Location

Investigational Site Number 840347

Bell Gardens, California, 90201, United States

Location

Investigational Site Number 840244

Escondido, California, 92025, United States

Location

Investigational Site Number 840257

Fresno, California, 93720, United States

Location

Investigational Site Number 840213

Greenbrae, California, 94904, United States

Location

Investigational Site Number 840267

Huntington Beach, California, 92648, United States

Location

Investigational Site Number 840230

La Jolla, California, 92037, United States

Location

Investigational Site Number 840235

La Mesa, California, 91942, United States

Location

Investigational Site Number 840274

La Mesa, California, 91942, United States

Location

Investigational Site Number 840222

Long Beach, California, 90806, United States

Location

Investigational Site Number 840243

Palm Springs, California, 92262, United States

Location

Investigational Site Number 840250

Spring Valley, California, 91978, United States

Location

Investigational Site Number 840209

Temecula, California, 92591, United States

Location

Investigational Site Number 840297

Torrance, California, 90502, United States

Location

Investigational Site Number 840272

Tustin, California, 92780, United States

Location

Investigational Site Number 840223

Walnut Creek, California, 94598, United States

Location

Investigational Site Number 840249

Colorado Springs, Colorado, 80907, United States

Location

Investigational Site Number 840331

Denver, Colorado, 80212, United States

Location

Investigational Site Number 840299

Boca Raton, Florida, 33432, United States

Location

Investigational Site Number 840285

Boynton Beach, Florida, 33472, United States

Location

Investigational Site Number 840221

Bradenton, Florida, 34208, United States

Location

Investigational Site Number 840233

Clearwater, Florida, 33765, United States

Location

Investigational Site Number 840212

Coral Gables, Florida, 33134, United States

Location

Investigational Site Number 840266

Coral Gables, Florida, 33134, United States

Location

Investigational Site Number 840204

Hialeah, Florida, 33012, United States

Location

Investigational Site Number 840248

Hollywood, Florida, 33021, United States

Location

Investigational Site Number 840226

Jacksonville, Florida, 32205, United States

Location

Investigational Site Number 840318

Jacksonville, Florida, 32216, United States

Location

Investigational Site Number 840224

Jacksonville, Florida, 32258, United States

Location

Investigational Site Number 840228

Miami, Florida, 33144, United States

Location

Investigational Site Number 840238

Miami, Florida, 33144, United States

Location

Investigational Site Number 840302

Miami, Florida, 33176, United States

Location

Investigational Site Number 840337

Miami Beach, Florida, 33141, United States

Location

Investigational Site Number 840227

New Port Richey, Florida, 34652, United States

Location

Investigational Site Number 840303

North Miami Beach, Florida, 33162, United States

Location

Investigational Site Number 840225

Ocala, Florida, 34471, United States

Location

Investigational Site Number 840291

Orlando, Florida, 32804, United States

Location

Investigational Site Number 840316

Orlando, Florida, 32806, United States

Location

Investigational Site Number 840216

Oviedo, Florida, 32765, United States

Location

Investigational Site Number 840332

Palm Harbor, Florida, 34684, United States

Location

Investigational Site Number 840288

Pembroke Pines, Florida, 33028, United States

Location

Investigational Site Number 840325

Port Charlotte, Florida, 33952, United States

Location

Investigational Site Number 840309

St. Petersburg, Florida, 33716, United States

Location

Investigational Site Number 840251

Tampa, Florida, 33603, United States

Location

Investigational Site Number 840339

West Palm Beach, Florida, 33401, United States

Location

Investigational Site Number 840245

Atlanta, Georgia, 30308, United States

Location

Investigational Site Number 840323

Stockbridge, Georgia, 30281, United States

Location

Investigational Site Number 840236

Honolulu, Hawaii, 96814, United States

Location

Investigational Site Number 840283

Idaho Falls, Idaho, 83404, United States

Location

Investigational Site Number 840278

Chicago, Illinois, 60607, United States

Location

Investigational Site Number 840320

Chicago, Illinois, 60612, United States

Location

Investigational Site Number 840276

Springfield, Illinois, 62704, United States

Location

Investigational Site Number 840314

Avon, Indiana, 46123, United States

Location

Investigational Site Number 840317

Avon, Indiana, 46123, United States

Location

Investigational Site Number 840214

Des Moines, Iowa, 50314, United States

Location

Investigational Site Number 840232

Overland Park, Kansas, 66210, United States

Location

Investigational Site Number 840287

Topeka, Kansas, 66606, United States

Location

Investigational Site Number 840344

Lexington, Kentucky, 40503, United States

Location

Investigational Site Number 840231

Murray, Kentucky, 42003, United States

Location

Investigational Site Number 840348

Metairie, Louisiana, 70006, United States

Location

Investigational Site Number 840290

New Orleans, Louisiana, 70119, United States

Location

Investigational Site Number 840208

Baltimore, Maryland, 21237, United States

Location

Investigational Site Number 840301

Rockville, Maryland, 20852, United States

Location

Investigational Site Number 840289

Fall River, Massachusetts, 02720, United States

Location

Investigational Site Number 840253

Haverhill, Massachusetts, 1830, United States

Location

Investigational Site Number 840270

Madison Heights, Michigan, 48071, United States

Location

Investigational Site Number 840300

Omaha, Nebraska, 68105, United States

Location

Investigational Site Number 840210

Omaha, Nebraska, 68131, United States

Location

Investigational Site Number 840263

Omaha, Nebraska, 68131, United States

Location

Investigational Site Number 840349

Las Vegas, Nevada, 89117, United States

Location

Investigational Site Number 840201

Las Vegas, Nevada, 89119, United States

Location

Investigational Site Number 840256

Las Vegas, Nevada, 89148, United States

Location

Investigational Site Number 840306

Hamilton, New Jersey, 08619, United States

Location

Investigational Site Number 840203

Sea Girt, New Jersey, 08750, United States

Location

Investigational Site Number 840295

Sicklerville, New Jersey, 08081, United States

Location

Investigational Site Number 840269

Albuquerque, New Mexico, 87106, United States

Location

Investigational Site Number 840310

New Hyde Park, New York, 11042, United States

Location

Investigational Site Number 840247

Asheville, North Carolina, 28803, United States

Location

Investigational Site Number 840296

Greensboro, North Carolina, 27408, United States

Location

Investigational Site Number 840275

Morganton, North Carolina, 28655, United States

Location

Investigational Site Number 840330

Cleveland, Ohio, 44122, United States

Location

Investigational Site Number 840307

Columbus, Ohio, 43213, United States

Location

Investigational Site Number 840229

Norman, Oklahoma, 73069, United States

Location

Investigational Site Number 840219

Bend, Oregon, 97701, United States

Location

Investigational Site Number 840240

Philadelphia, Pennsylvania, 19139, United States

Location

Investigational Site Number 840308

Tipton, Pennsylvania, 16684, United States

Location

Investigational Site Number 840252

Greer, South Carolina, 29651, United States

Location

Investigational Site Number 840237

Spartanburg, South Carolina, 29303, United States

Location

Investigational Site Number 840294

Dakota Dunes, South Dakota, 57049, United States

Location

Investigational Site Number 840260

Bristol, Tennessee, 37620, United States

Location

Investigational Site Number 840262

Chattanooga, Tennessee, 37404, United States

Location

Investigational Site Number 840342

Corpus Christi, Texas, 78404, United States

Location

Investigational Site Number 840268

Dallas, Texas, 75230, United States

Location

Investigational Site Number 840292

Dallas, Texas, 75230, United States

Location

Investigational Site Number 840315

Dallas, Texas, 75231, United States

Location

Investigational Site Number 840242

Dallas, Texas, 75246, United States

Location

Investigational Site Number 840326

Edinburg, Texas, 78539, United States

Location

Investigational Site Number 840338

Houston, Texas, 77002, United States

Location

Investigational Site Number 840218

Houston, Texas, 77004, United States

Location

Investigational Site Number 840328

Houston, Texas, 77074, United States

Location

Investigational Site Number 840259

Houston, Texas, 77095, United States

Location

Investigational Site Number 840327

Pearland, Texas, 77584, United States

Location

Investigational Site Number 840282

San Antonio, Texas, 78229, United States

Location

Investigational Site Number 840202

Murray, Utah, 84123, United States

Location

Investigational Site Number 840343

Salt Lake City, Utah, 84107, United States

Location

Investigational Site Number 840239

Burke, Virginia, 22015, United States

Location

Investigational Site Number 840206

Manassas, Virginia, 20110, United States

Location

Investigational Site Number 840246

Renton, Washington, 98055, United States

Location

Investigational Site Number 840311

Milwaukee, Wisconsin, 53209-0996, United States

Location

Investigational Site Number 100205

Blagoevgrad, 2700, Bulgaria

Location

Investigational Site Number 100203

Byala, 7100, Bulgaria

Location

Investigational Site Number 100201

Plovdiv, 4002, Bulgaria

Location

Investigational Site Number 100204

Plovdiv, 4002, Bulgaria

Location

Investigational Site Number 100206

Sofia, 1431, Bulgaria

Location

Investigational Site Number 124204

Brampton, L6R 3J5, Canada

Location

Investigational Site Number 124211

Etobicoke, M9R 4E1, Canada

Location

Investigational Site Number 124208

Laval, H7T 2P5, Canada

Location

Investigational Site Number 124214

London, N6A 5G6, Canada

Location

Investigational Site Number 124210

Montreal, H1Y 3L1, Canada

Location

Investigational Site Number 124218

Montreal, H4N 3C5, Canada

Location

Investigational Site Number 124206

Pointe-Claire, H9R 4S3, Canada

Location

Investigational Site Number 124216

Saint-Laurent, H4T 1Z9, Canada

Location

Investigational Site Number 124219

Sherbrooke, J1H 1Z1, Canada

Location

Investigational Site Number 124201

Thornhill, L4J 8L7, Canada

Location

Investigational Site Number 124209

Thornhill, L4J 8L7, Canada

Location

Investigational Site Number 124212

Toronto, M9W 4L9, Canada

Location

Investigational Site Number 203201

Brno, 62500, Czechia

Location

Investigational Site Number 203205

Brno, 65691, Czechia

Location

Investigational Site Number 203204

Havířov, 73601, Czechia

Location

Investigational Site Number 203203

Prague, 10034, Czechia

Location

Investigational Site Number 203202

Prague, 18100, Czechia

Location

Investigational Site Number 208205

Aalborg, 9100, Denmark

Location

Investigational Site Number 208203

Esbjerg, 6700, Denmark

Location

Investigational Site Number 208209

Hellerup, 2900, Denmark

Location

Investigational Site Number 208202

Herlev, 2730, Denmark

Location

Investigational Site Number 208206

Hvidovre, 2650, Denmark

Location

Investigational Site Number 208210

Kolding, 6000, Denmark

Location

Investigational Site Number 208207

København NV, 2400, Denmark

Location

Investigational Site Number 208201

Odense C, 5000, Denmark

Location

Investigational Site Number 208204

Viborg, 8800, Denmark

Location

Investigational Site Number 233204

Tallinn, 13419, Estonia

Location

Investigational Site Number 233203

Tartu, 50406, Estonia

Location

Investigational Site Number 233205

Tartu, 50410, Estonia

Location

Investigational Site Number 246208

Helsinki, 260, Finland

Location

Investigational Site Number 246202

Kokkola, 67100, Finland

Location

Investigational Site Number 246207

Oulu, 90100, Finland

Location

Investigational Site Number 246206

Tampere, 33100, Finland

Location

Investigational Site Number 246205

Turku, 20100, Finland

Location

Investigational Site Number 348205

Balassagyarmat, 2660, Hungary

Location

Investigational Site Number 348201

Budapest, 1036, Hungary

Location

Investigational Site Number 348207

Budapest, 1036, Hungary

Location

Investigational Site Number 348212

Budapest, 1083, Hungary

Location

Investigational Site Number 348210

Budapest, 1134, Hungary

Location

Investigational Site Number 348202

Úrhida, 8142, Hungary

Location

Investigational Site Number 392214

Fujimi, Japan

Location

Investigational Site Number 392215

Fujimi, Japan

Location

Investigational Site Number 392206

Ise-Shi, Japan

Location

Investigational Site Number 392217

Kitaazumi-Gun, Japan

Location

Investigational Site Number 392208

Matsumoto, Japan

Location

Investigational Site Number 392210

Matsumoto-Shi, Japan

Location

Investigational Site Number 392205

Midori, Japan

Location

Investigational Site Number 392203

Mito, Japan

Location

Investigational Site Number 392216

Sakai, Japan

Location

Investigational Site Number 392213

Shimotsuke, Japan

Location

Investigational Site Number 392218

Shunan-Shi, Japan

Location

Investigational Site Number 392204

Yamagata, Japan

Location

Investigational Site Number 428206

Riga, 1024, Latvia

Location

Investigational Site Number 428203

Riga, LV-1002, Latvia

Location

Investigational Site Number 428205

Riga, LV-1050, Latvia

Location

Investigational Site Number 428202

Sigulda, LV-2150, Latvia

Location

Investigational Site Number 428201

Ventspils, LV-3601, Latvia

Location

Investigational Site Number 440203

Kaunas, 48259, Lithuania

Location

Investigational Site Number 440204

Kaunas, LT-49456, Lithuania

Location

Investigational Site Number 440201

Klaipėda, LT-92253, Lithuania

Location

Investigational Site Number 440202

Klaipėda, LT-92304, Lithuania

Location

Investigational Site Number 440205

Vilnius, LT-08661, Lithuania

Location

Investigational Site Number 528204

Almere Stad, 1311 RL, Netherlands

Location

Investigational Site Number 528209

Beek, 6191 JW, Netherlands

Location

Investigational Site Number 528205

Breda, 4811 SW, Netherlands

Location

Investigational Site Number 528207

Leiderdorp, 2352 RA, Netherlands

Location

Investigational Site Number 528203

Rotterdam, 3021 HC, Netherlands

Location

Investigational Site Number 528202

Velp, 6883 ES, Netherlands

Location

Investigational Site Number 840709

Cagua, 725, Puerto Rico

Location

Investigational Site Number 840706

Carolina, 987, Puerto Rico

Location

Investigational Site Number 840704

San Juan, 00917, Puerto Rico

Location

Investigational Site Number 840710

San Juan, 00917, Puerto Rico

Location

Investigational Site Number 840703

San Juan, 917, Puerto Rico

Location

Investigational Site Number 840708

San Juan, 926, Puerto Rico

Location

Investigational Site Number 642208

Bacau, 600164, Romania

Location

Investigational Site Number 642212

Bucharest, 020359, Romania

Location

Investigational Site Number 642201

Bucharest, 20475, Romania

Location

Investigational Site Number 642202

Cluj-Napoca, 400006, Romania

Location

Investigational Site Number 642213

Oradea, 410169, Romania

Location

Investigational Site Number 642207

Reşiţa, 320076, Romania

Location

Investigational Site Number 642205

Sibiu, 550371, Romania

Location

Investigational Site Number 642203

Târgu Mureş, 540142, Romania

Location

Investigational Site Number 642204

Târgu Mureş, 540142, Romania

Location

Investigational Site Number 642206

Timișoara, 300133, Romania

Location

Investigational Site Number 642209

Timișoara, 300456, Romania

Location

Investigational Site Number 703205

Banská Bystrica, 97517, Slovakia

Location

Investigational Site Number 703202

Bardejov, 085 01, Slovakia

Location

Investigational Site Number 703203

Bratislava, 85101, Slovakia

Location

Investigational Site Number 703201

Levice, 93405, Slovakia

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Investigational Site Number 703206

Levice, 95401, Slovakia

Location

Investigational Site Number 703207

Lučenec, 98401, Slovakia

Location

Investigational Site Number 752205

Kristianstad, 29185, Sweden

Location

Investigational Site Number 752206

Malmo, 211 52, Sweden

Location

Investigational Site Number 752201

Stockholm, 11526, Sweden

Location

Investigational Site Number 752204

Vällingby, 16268, Sweden

Location

Related Publications (4)

• Bolli GB, Riddle MC, Bergenstal RM, Ziemen M, Sestakauskas K, Goyeau H, Home PD; on behalf of the EDITION 3 study investigators. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naive people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015 Apr;17(4):386-94. doi: 10.1111/dom.12438. Epub 2015 Feb 12.

  PMID: 25641260 RESULT

• Yale JF, Aroda VR, Charbonnel B, Sinclair AJ, Trescoli C, Cahn A, Bigot G, Merino-Trigo A, Brulle-Wohlhueter C, Bolli GB, Ritzel R. Glycaemic control and hypoglycaemia risk with insulin glargine 300 U/mL versus glargine 100 U/mL: A patient-level meta-analysis examining older and younger adults with type 2 diabetes. Diabetes Metab. 2020 Apr;46(2):110-118. doi: 10.1016/j.diabet.2018.10.002. Epub 2018 Oct 23.

  PMID: 30366067 DERIVED

• Bolli GB, Wysham C, Fisher M, Chevalier S, Cali AMG, Leroy B, Riddle MC. A post-hoc pooled analysis to evaluate the risk of hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus 100 U/mL (Gla-100) over wider nocturnal windows in individuals with type 2 diabetes on a basal-only insulin regimen. Diabetes Obes Metab. 2019 Feb;21(2):402-407. doi: 10.1111/dom.13515. Epub 2018 Oct 2.

  PMID: 30160030 DERIVED

• Yale JF, Pettus JH, Brito-Sanfiel M, Lavalle-Gonzalez F, Merino-Trigo A, Stella P, Chevalier S, Buzzetti R. The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3. PLoS One. 2018 Jan 25;13(1):e0190579. doi: 10.1371/journal.pone.0190579. eCollection 2018.

  PMID: 29370218 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact --US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: August 30, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: March 1, 2014
• Last Updated: June 24, 2015
• Results First Posted: April 23, 2015

Record last verified: 2015-05

Locations

LI (5); CZ (5); SE (4); DK (9); PR (6); RO (11); NL (6); US (117); SL (6); LA (5); CA (12); BU (5); ES (3); HU (6); JP (12); FI (5)