Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

NCT01719003 | Completed Phase 3 Results

• 2 other identifiers: 1276.12010-021375-92
• Study Type: interventional
• Target: 1,413
• Locations: 21 countries
• Sites: 190

Brief Summary

This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24

  Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means

  baseline and 24 weeks

Secondary Outcomes (2)

• FPG (Fasting Plasma Glucose) Change From Baseline at Week 24

  baseline and 24 weeks

• Body Weight Change From Baseline at Week 24

  baseline and 24 weeks

Study Arms (9)

Empagliflozin low dose qd

EXPERIMENTAL

Empagliflozin low dose once daily

Drug: Empagliflozin low dose qd

Empagliflozin high dose qd

EXPERIMENTAL

Empagliflozin high dose once daily

Drug: Empagliflozin high dose qd

OL empa high dose + met 1000 mg bid

EXPERIMENTAL

Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. Patients already enrolled in the open-label arm according to protocol version 1.0 can complete the study.

Drug: Metformin 1000 mg bid; Drug: Empagliflozin high dose bid

Empagliflozin low dose + met 500 mg bid

EXPERIMENTAL

Empagliflozin low dose split twice daily + metformin 500 mg twice daily

Drug: Metformin 500 mg bid; Drug: Empagliflozin low dose bid

Empagliflozin low dose + met 1000 mg bid

EXPERIMENTAL

Empagliflozin low dose split twice daily + metformin 1000 mg twice daily

Drug: Empagliflozin low dose bid; Drug: Metformin 1000 mg bid

Empagliflozin high dose + met 500 mg bid

EXPERIMENTAL

Empagliflozin high dose split twice daily + metformin 500 mg twice daily

Drug: Metformin 500 mg bid; Drug: Empagliflozin high dose bid

Empagliflozin high dose + met 1000mg bid

EXPERIMENTAL

Empagliflozin high dose split twice daily + metformin 1000 mg twice daily

Drug: Metformin 1000 mg bid; Drug: Empagliflozin high dose bid

Metformin 500 mg bid

EXPERIMENTAL

Metformin 500 mg twice daily

Drug: Metformin 500 mg bid

Metformin 1000 mg bid

EXPERIMENTAL

Metformin 1000 mg twice daily

Drug: Metformin 1000 mg bid

Interventions

Metformin 500 mg bid DRUG

Metformin 500 mg twice daily

Empagliflozin low dose + met 500 mg bid

Metformin 1000 mg bid DRUG

Metformin 1000 mg twice daily

OL empa high dose + met 1000 mg bid

Empagliflozin low dose qd DRUG

Empagliflozin low dose once daily

Empagliflozin low dose qd

Empagliflozin high dose qd DRUG

Empagliflozin high dose once daily

Empagliflozin high dose qd

Empagliflozin low dose bid DRUG

Empagliflozin low dose split twice daily

Empagliflozin low dose + met 500 mg bid

Empagliflozin high dose bid DRUG

Empagliflozin high dose split twice daily

OL empa high dose + met 1000 mg bid

Eligibility Criteria

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

You may qualify if:

• Diagnosis of type 2 diabetes mellitus prior to informed consent
• Male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomization
• HbA1c \>=7.5% and \<= 12% (\>=58.5 mmol/mol and \<=107.7 mmol/mol)
• Body Mass Index (BMI) \<= 45 kg/m2 at screening

You may not qualify if:

• Uncontrolled hyperglycemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second laboratory measurement (not on the same day)
• Any antidiabetic drug within 12 weeks prior to randomization
• Impaired renal function, defined as estimated creatinine clearance rate (eCCr) \<60 ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period
• Contraindications to metformin according to the local label

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (190)

1276.1.10014 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1276.1.10019 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1276.1.10044 Boehringer Ingelheim Investigational Site

Manley Hot Springs, Alaska, United States

Location

1276.1.10010 Boehringer Ingelheim Investigational Site

Glendale, Arizona, United States

Location

1276.1.10035 Boehringer Ingelheim Investigational Site

Searcy, Arkansas, United States

Location

1276.1.10046 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Location

1276.1.10006 Boehringer Ingelheim Investigational Site

Huntington Beach, California, United States

Location

1276.1.10043 Boehringer Ingelheim Investigational Site

La Mesa, California, United States

Location

1276.1.10009 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1276.1.10040 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1276.1.10045 Boehringer Ingelheim Investigational Site

Oceanside, California, United States

Location

1276.1.10042 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

Location

1276.1.10001 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

1276.1.10003 Boehringer Ingelheim Investigational Site

Northglenn, Colorado, United States

Location

1276.1.10026 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

1276.1.10024 Boehringer Ingelheim Investigational Site

Oldsmar, Florida, United States

Location

1276.1.10027 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

Location

1276.1.10023 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

Location

1276.1.10034 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Location

1276.1.10032 Boehringer Ingelheim Investigational Site

Fall River, Massachusetts, United States

Location

1276.1.10036 Boehringer Ingelheim Investigational Site

Bridgman, Michigan, United States

Location

1276.1.10037 Boehringer Ingelheim Investigational Site

Hazelwood, Missouri, United States

Location

1276.1.10007 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

1276.1.10015 Boehringer Ingelheim Investigational Site

Union, New Jersey, United States

Location

1276.1.10033 Boehringer Ingelheim Investigational Site

Asheboro, North Carolina, United States

Location

1276.1.10022 Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

Location

1276.1.10002 Boehringer Ingelheim Investigational Site

Lenoir, North Carolina, United States

Location

1276.1.10005 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1276.1.10011 Boehringer Ingelheim Investigational Site

Gallipolis, Ohio, United States

Location

1276.1.10030 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

Location

1276.1.10008 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

1276.1.10013 Boehringer Ingelheim Investigational Site

Hodges, South Carolina, United States

Location

1276.1.10017 Boehringer Ingelheim Investigational Site

Humboldt, Tennessee, United States

Location

1276.1.10018 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1276.1.10025 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1276.1.10028 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1276.1.10016 Boehringer Ingelheim Investigational Site

Kingwood, Texas, United States

Location

1276.1.10021 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1276.1.10041 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1276.1.10004 Boehringer Ingelheim Investigational Site

Manassas, Virginia, United States

Location

1276.1.10012 Boehringer Ingelheim Investigational Site

Wenatchee, Washington, United States

Location

1276.1.55008 Boehringer Ingelheim Investigational Site

Belém, Brazil

Location

1276.1.55003 Boehringer Ingelheim Investigational Site

Brasília, Brazil

Location

1276.1.55006 Boehringer Ingelheim Investigational Site

Fortaleza, Brazil

Location

1276.1.55007 Boehringer Ingelheim Investigational Site

Fortaleza, Brazil

Location

1276.1.55009 Boehringer Ingelheim Investigational Site

Fortaleza, Brazil

Location

1276.1.55004 Boehringer Ingelheim Investigational Site

Goiânia, Brazil

Location

1276.1.55002 Boehringer Ingelheim Investigational Site

Porto Alegre, Brazil

Location

1276.1.55001 Boehringer Ingelheim Investigational Site

São Paulo, Brazil

Location

1276.1.20003 Boehringer Ingelheim Investigational Site

Coquitlam, British Columbia, Canada

Location

1276.1.20012 Boehringer Ingelheim Investigational Site

Coquitlam, British Columbia, Canada

Location

1276.1.20008 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Location

1276.1.20004 Boehringer Ingelheim Investigational Site

Antigonish, Nova Scotia, Canada

Location

1276.1.20005 Boehringer Ingelheim Investigational Site

Hawkesbury, Ontario, Canada

Location

1276.1.20013 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Location

1276.1.20010 Boehringer Ingelheim Investigational Site

Strathroy, Ontario, Canada

Location

1276.1.20006 Boehringer Ingelheim Investigational Site

Thornhill, Ontario, Canada

Location

1276.1.20007 Boehringer Ingelheim Investigational Site

Mirabel, Quebec, Canada

Location

1276.1.20002 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Location

1276.1.20001 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Location

1276.1.42002 Boehringer Ingelheim Investigational Site

Benátky nad Jizerou, Czechia

Location

1276.1.42008 Boehringer Ingelheim Investigational Site

Olomouc, Czechia

Location

1276.1.42007 Boehringer Ingelheim Investigational Site

Ostrava, Czechia

Location

1276.1.42009 Boehringer Ingelheim Investigational Site

Pilsen, Czechia

Location

1276.1.42003 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1276.1.42004 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1276.1.42010 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1276.1.95001 Boehringer Ingelheim Investigational Site

Abbasia Cairo, Egypt, Egypt

Location

1276.1.95003 Boehringer Ingelheim Investigational Site

Al Manial, Cairo, Egypt, Egypt

Location

1276.1.95004 Boehringer Ingelheim Investigational Site

Alexandria, Egypt

Location

1276.1.95002 Boehringer Ingelheim Investigational Site

El Darasa Cairo Egypt, Egypt

Location

1276.1.33004 Boehringer Ingelheim Investigational Site

Behren-lès-Forbach, France

Location

1276.1.33012 Boehringer Ingelheim Investigational Site

Bersée, France

Location

1276.1.33005 Boehringer Ingelheim Investigational Site

Cournonterral, France

Location

1276.1.33007 Boehringer Ingelheim Investigational Site

Hautmont, France

Location

1276.1.33013 Boehringer Ingelheim Investigational Site

Paris, France

Location

1276.1.33001 Boehringer Ingelheim Investigational Site

Poitiers, France

Location

1276.1.33006 Boehringer Ingelheim Investigational Site

Saint-Génis-des-Fontaines, France

Location

1276.1.33003 Boehringer Ingelheim Investigational Site

Savonnières, France

Location

1276.1.33002 Boehringer Ingelheim Investigational Site

Thouars, France

Location

1276.1.33011 Boehringer Ingelheim Investigational Site

Thun-Saint-Amand, France

Location

1276.1.33010 Boehringer Ingelheim Investigational Site

Tours, France

Location

1276.1.33009 Boehringer Ingelheim Investigational Site

Vandome, France

Location

1276.1.33008 Boehringer Ingelheim Investigational Site

Vieux-Condé, France

Location

1276.1.49005 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1276.1.49008 Boehringer Ingelheim Investigational Site

Celle, Germany

Location

1276.1.49006 Boehringer Ingelheim Investigational Site

Dortmund, Germany

Location

1276.1.49011 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1276.1.49003 Boehringer Ingelheim Investigational Site

Essen, Germany

Location

1276.1.49007 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Location

1276.1.49014 Boehringer Ingelheim Investigational Site

Neuwied, Germany

Location

1276.1.49004 Boehringer Ingelheim Investigational Site

Offenbach, Germany

Location

1276.1.49002 Boehringer Ingelheim Investigational Site

Stuhr-Brinkum, Germany

Location

1276.1.49012 Boehringer Ingelheim Investigational Site

Teuchern, Germany

Location

1276.1.50002 Boehringer Ingelheim Investigational Site

Barbena Santa Rosa, Guatemala

Location

1276.1.50003 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

Location

1276.1.50005 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

Location

1276.1.50006 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

Location

1276.1.50001 Boehringer Ingelheim Investigational Site

Quetzaltenango, Guatemala

Location

1276.1.96001 Boehringer Ingelheim Investigational Site

Beirut, Lebanon

Location

1276.1.96002 Boehringer Ingelheim Investigational Site

El Chouf, Lebanon

Location

1276.1.96003 Boehringer Ingelheim Investigational Site

Saida, Lebanon

Location

1276.1.96004 Boehringer Ingelheim Investigational Site

Saida, Lebanon

Location

1276.1.60002 Boehringer Ingelheim Investigational Site

Ipoh, Perak, Malaysia

Location

1276.1.60001 Boehringer Ingelheim Investigational Site

Johor Bahru, Malaysia

Location

1276.1.60003 Boehringer Ingelheim Investigational Site

Kubang Kerian, Malaysia

Location

1276.1.52004 Boehringer Ingelheim Investigational Site

Aguascalientes, Mexico

Location

1276.1.52007 Boehringer Ingelheim Investigational Site

Aguascalientes, Mexico

Location

1276.1.52003 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1276.1.52002 Boehringer Ingelheim Investigational Site

Mexico City, Mexico

Location

1276.1.52001 Boehringer Ingelheim Investigational Site

Monterrey, Mexico

Location

1276.1.52006 Boehringer Ingelheim Investigational Site

San Lucas Tepetlcalco, Mexico

Location

1276.1.52005 Boehringer Ingelheim Investigational Site

Zapopan, Mexico

Location

1276.1.51001 Boehringer Ingelheim Investigational Site

Lima, Peru

Location

1276.1.51002 Boehringer Ingelheim Investigational Site

Lima, Peru

Location

1276.1.51003 Boehringer Ingelheim Investigational Site

Lima, Peru

Location

1276.1.51004 Boehringer Ingelheim Investigational Site

Lima, Peru

Location

1276.1.51005 Boehringer Ingelheim Investigational Site

Lima, Peru

Location

1276.1.63009 Boehringer Ingelheim Investigational Site

Cebu City, Cebu, Philippines

Location

1276.1.63002 Boehringer Ingelheim Investigational Site

Cebu City, Philippines, Philippines

Location

1276.1.63004 Boehringer Ingelheim Investigational Site

Davao City, Philippines

Location

1276.1.63003 Boehringer Ingelheim Investigational Site

Iloilo City, Philippines

Location

1276.1.63006 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

1276.1.63001 Boehringer Ingelheim Investigational Site

Marikina City, Philippines

Location

1276.1.63005 Boehringer Ingelheim Investigational Site

Maybunga, Pasig City, Philippines

Location

1276.1.63007 Boehringer Ingelheim Investigational Site

San Juan City, Philippines

Location

1276.1.63008 Boehringer Ingelheim Investigational Site

Tarlac City, Philippines

Location

1276.1.70012 Boehringer Ingelheim Investigational Site

Barnaul, Russia

Location

1276.1.70011 Boehringer Ingelheim Investigational Site

Kemerovo, Russia

Location

1276.1.70015 Boehringer Ingelheim Investigational Site

Novosibirsk, Russia

Location

1276.1.70016 Boehringer Ingelheim Investigational Site

Novosibirsk, Russia

Location

1276.1.70018 Boehringer Ingelheim Investigational Site

Novosibirsk, Russia

Location

1276.1.70007 Boehringer Ingelheim Investigational Site

Petrozavodsk, Russia

Location

1276.1.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1276.1.70006 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1276.1.70017 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1276.1.70009 Boehringer Ingelheim Investigational Site

Saratov, Russia

Location

1276.1.70010 Boehringer Ingelheim Investigational Site

Smolensk, Russia

Location

1276.1.70013 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

1276.1.38104 Boehringer Ingelheim Investigational Site

Belgrade, Serbia

Location

1276.1.38105 Boehringer Ingelheim Investigational Site

Belgrade, Serbia

Location

1276.1.38106 Boehringer Ingelheim Investigational Site

Belgrade, Serbia

Location

1276.1.38107 Boehringer Ingelheim Investigational Site

Belgrade, Serbia

Location

1276.1.38103 Boehringer Ingelheim Investigational Site

Kragujevac, Serbia

Location

1276.1.38101 Boehringer Ingelheim Investigational Site

Niš, Serbia

Location

1276.1.38108 Boehringer Ingelheim Investigational Site

Novi Sad, Serbia

Location

1276.1.38102 Boehringer Ingelheim Investigational Site

Zaječar, Serbia

Location

1276.1.82006 Boehringer Ingelheim Investigational Site

Deagu, South Korea

Location

1276.1.82010 Boehringer Ingelheim Investigational Site

Goyang, South Korea

Location

1276.1.82001 Boehringer Ingelheim Investigational Site

Incheon, South Korea

Location

1276.1.82009 Boehringer Ingelheim Investigational Site

Pusan, South Korea

Location

1276.1.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1276.1.82004 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1276.1.82005 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1276.1.82007 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1276.1.82008 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1276.1.82003 Boehringer Ingelheim Investigational Site

Wŏnju, South Korea

Location

1276.1.34048 Boehringer Ingelheim Investigational Site

Alicante, Spain

Location

1276.1.34050 Boehringer Ingelheim Investigational Site

Alzira, Spain

Location

1276.1.34028 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1276.1.34045 Boehringer Ingelheim Investigational Site

Pozuelo de Alarcón, Spain

Location

1276.1.34034 Boehringer Ingelheim Investigational Site

Sabadell (Barcelona), Spain

Location

1276.1.34027 Boehringer Ingelheim Investigational Site

Salamanca, Spain

Location

1276.1.34052 Boehringer Ingelheim Investigational Site

Tarragona, Spain

Location

1276.1.34051 Boehringer Ingelheim Investigational Site

Zaragoza, Spain

Location

1276.1.88005 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

Location

1276.1.88002 Boehringer Ingelheim Investigational Site

New Taipei City, Taiwan

Location

1276.1.88001 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

1276.1.88003 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

1276.1.88004 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

1276.1.88006 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1276.1.66001 Boehringer Ingelheim Investigational Site

Bangkok, Thailand, Thailand

Location

1276.1.66003 Boehringer Ingelheim Investigational Site

Bangkok, Thailand, Thailand

Location

1276.1.66002 Boehringer Ingelheim Investigational Site

Nakhon Ratchasima, Thailand

Location

1276.1.90003 Boehringer Ingelheim Investigational Site

Ankara, Turkey (Türkiye)

Location

1276.1.90004 Boehringer Ingelheim Investigational Site

Antalya, Turkey (Türkiye)

Location

1276.1.90006 Boehringer Ingelheim Investigational Site

Denizli, Turkey (Türkiye)

Location

1276.1.90002 Boehringer Ingelheim Investigational Site

Erzurum, Turkey (Türkiye)

Location

1276.1.90005 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1276.1.90001 Boehringer Ingelheim Investigational Site

Izmir, Turkey (Türkiye)

Location

1276.1.44002 Boehringer Ingelheim Investigational Site

Bolton, United Kingdom

Location

1276.1.44001 Boehringer Ingelheim Investigational Site

Bradford-on-Avon, United Kingdom

Location

1276.1.44005 Boehringer Ingelheim Investigational Site

Chippenham, United Kingdom

Location

1276.1.44006 Boehringer Ingelheim Investigational Site

Dagenham, United Kingdom

Location

1276.1.44004 Boehringer Ingelheim Investigational Site

Doncaster, United Kingdom

Location

1276.1.44008 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

1276.1.44003 Boehringer Ingelheim Investigational Site

Leeds, United Kingdom

Location

1276.1.44007 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

1276.1.44011 Boehringer Ingelheim Investigational Site

Mortimer, United Kingdom

Location

1276.1.44009 Boehringer Ingelheim Investigational Site

Sandbach, United Kingdom

Location

Related Publications (1)

• Hadjadj S, Rosenstock J, Meinicke T, Woerle HJ, Broedl UC. Initial Combination of Empagliflozin and Metformin in Patients With Type 2 Diabetes. Diabetes Care. 2016 Oct;39(10):1718-28. doi: 10.2337/dc16-0522. Epub 2016 Aug 4.

  PMID: 27493136 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia

Interventions

Metformin; BID protein, human; empagliflozin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 1, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 19, 2016
• Results First Posted: February 19, 2016

Record last verified: 2016-01

Locations

ME (7); RU (12); ES (8); KR (10); TH (3); CZ (7); SE (8); DE (10); EG (4); TW (6); FR (13); CA (11); GU (5); PH (9); BR (8); US (41); MY (3); PE (5); TU (6); GB (10); LE (4)