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Search / Trial NCT01778049

Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

Launched by BOEHRINGER INGELHEIM · Jan 28, 2013

Trial Information

Current as of April 25, 2025

Completed

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion criteria:
  • 1. Signed and dated ICF (Informed Consent Form)
  • 2. Male or female on diet and exercise regime and on stable background metformin \> or equal to 1500 mg or maximun dose according to local label
  • 3. HBA1c (Glicoslated Hemoglobin) \> or equal to 8% and \< or equal to 10.5 % at Visit 1
  • 4. HbA1c \> or equal to 7 and \< or equal to 10.5 at Visit 4
  • 5. Age \> or equal to 18 years
  • 6. BMI (Body Mass Index) \< or equal to 45
  • Exclusion criteria:
  • 1. Uncontrolled hyperglycemia during open label period and placebo add on "run-in" period
  • 2. Use of any other antidiabetic
  • 3. Renal function below 60 ml/min/1.73 m2
  • 4. Antiobesity drugs or aggresive diets
  • 5. Gastorintestinal surgeries
  • 6. Current systemic steroids or uncontrolled endocrine disorders other than Diabetes Type 2
  • 7. Acute coronary syndrome and stroke within 3 months of informed consent
  • 8. Known allergies to DPP-IV (Dypeptidil Peptidase IV) or SGLT-2 (Sodium Glucose Transporter 2) inhibitors

About Boehringer Ingelheim

Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.

Locations

Chino, California, United States

Huntington Beach, California, United States

San Diego, California, United States

San Diego, California, United States

Sylmar, California, United States

Miami, Florida, United States

Orlando, Florida, United States

Oviedo, Florida, United States

Tamarac, Florida, United States

Conyers, Georgia, United States

Snellville, Georgia, United States

Avon, Indiana, United States

Muncie, Indiana, United States

Elkton, Maryland, United States

Stevensville, Michigan, United States

Salisbury, North Carolina, United States

Bismarck, North Dakota, United States

Oklahoma City, Oklahoma, United States

Pittsburgh, Pennsylvania, United States

Union, South Carolina, United States

North Richland Hills, Texas, United States

Draper, Utah, United States

Richmond, Virginia, United States

Virginia Beach, Virginia, United States

Caba, , Argentina

Caba, , Argentina

Capital Federal, , Argentina

Capital Federal, , Argentina

Capital Federal, , Argentina

Cordoba, , Argentina

Cordoba, , Argentina

Córdoba, , Argentina

Godoy Cruz, Mendoza, , Argentina

Mar Del Plata, , Argentina

Salta, , Argentina

San Isidro, , Argentina

Zarate, , Argentina

Cardiff, New South Wales, Australia

East Ringwood, Victoria, Australia

Heidelberg Heights, Victoria, Australia

Mirrabooka, Western Australia, Australia

Edmonton, Alberta, Canada

Red Deer, Alberta, Canada

Chilliwack, British Columbia, Canada

Coquitlam, British Columbia, Canada

Vancouver, British Columbia, Canada

Winnipeg, Manitoba, Canada

Winnipeg, Manitoba, Canada

Moncton, New Brunswick, Canada

Burlington, Ontario, Canada

Strathroy, Ontario, Canada

Sudbury, Ontario, Canada

Drummondville, Quebec, Canada

Montreal, Quebec, Canada

ávila, , El Salvador

Asslar, , Germany

Berlin, , Germany

Elsterwerda, , Germany

Hamburg, , Germany

Hatten, , Germany

Kiel Kronshagen, , Germany

Köln, , Germany

Lübeck, , Germany

Münster, , Germany

Pirna, , Germany

St. Ingbert/Oberwürzbach, , Germany

Unterschneidheim, , Germany

Wangen, , Germany

Ancona, , Italy

Catania, , Italy

Catania, , Italy

Catania, , Italy

Latina, , Italy

Milano, , Italy

Milano, , Italy

Olbia (Ot), , Italy

Orbassano (To), , Italy

Palermo, , Italy

Pistoia, , Italy

Roma, , Italy

Sesto San Giovanni (Mi), , Italy

Siena, , Italy

Terni, , Italy

Cantanhede, , Portugal

Porto, , Portugal

Sandim, , Portugal

Tornada, , Portugal

Valadares, , Portugal

Vila Nova De Gaia, , Portugal

Chelyabinsk, , Russian Federation

Saint Petersburg, , Russian Federation

Saratov, , Russian Federation

Saratov, , Russian Federation

St. Petersburg, , Russian Federation

Yaroslavl, , Russian Federation

Barcelona, , Spain

Canet De Mar, , Spain

Centelles, , Spain

L'hospitalet De Llobregat (Barcelona), , Spain

La Roca Del Vallès, , Spain

Madrid, , Spain

Malaga, , Spain

Mataró, , Spain

Málaga, , Spain

Pineda De Mar, , Spain

Sabadell, , Spain

Tarragona, , Spain

Chernivtsi, , Ukraine

Dnipropetrovs'k, , Ukraine

Kiev, , Ukraine

Kiev, , Ukraine

Lviv, , Ukraine

Vinnitsa, , Ukraine

Zhytomyr, , Ukraine

Patients applied

0 patients applied

Trial Officials

Boehringer Ingelheim

Study Chair

Boehringer Ingelheim

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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