Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes
Launched by BOEHRINGER INGELHEIM · Nov 27, 2012
Trial Information
Current as of April 25, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • 1. Diagnosis of type 2 diabetes mellitus.
- • 2. Male and female patients on diet and exercise regimen, pre-treated with immediate release metformin for at least 12 weeks, and patients should be on a dose higher or equal to 1500 mg/day of metformin, or maximum tolerated dose, or maximum dose as per local label.
- • 3. HbA1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.
- • 4. Age 18 years or more at screening.
- • 5. Body Mass Index lower or equal to 45 kg/m2 at screening visit.
- • 6. Signed and dated written informed consent.
- Exclusion criteria:
- • 1. Uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after an overnight fast.
- • 2. Use of any other antidiabetic drug (except metformin background therapy).
- • 3. Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent.
- • 4. Indication of liver disease.
- • 5. Impaired renal function.
- • 6. Gastrointestinal surgery.
- • 7. Treatment with anti-obesity drugs within 3 months prior to screening, or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
- • 8. Current treatment with systemic steroids at time of informed consent or uncontrolled endocrine disorder except type 2 diabetes mellitus.
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Gulf Shores, Alabama, United States
Norwalk, California, United States
San Diego, California, United States
San Diego, California, United States
Northglenn, Colorado, United States
Coral Gables, Florida, United States
Miami, Florida, United States
Oldsmar, Florida, United States
Palm Coast, Florida, United States
Port Orange, Florida, United States
Blue Ridge, Georgia, United States
Marietta, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Methuen, Massachusetts, United States
Troy, Michigan, United States
St. Louis, Missouri, United States
Omaha, Nebraska, United States
Newington, New Hampshire, United States
Asheboro, North Carolina, United States
Burlington, North Carolina, United States
Shelby, North Carolina, United States
Winston Salem, North Carolina, United States
Dayton, Ohio, United States
Corvallis, Oregon, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Liverpool, New South Wales, Australia
St Leonards, New South Wales, Australia
Carina Heights, Queensland, Australia
Herston, Queensland, Australia
Malvern, Victoria, Australia
Nedlands, Western Australia, Australia
Brasilia, , Brazil
Goiania, , Brazil
Sao Paulo, , Brazil
Sao Paulo, , Brazil
Sao Paulo, , Brazil
Burnaby, British Columbia, Canada
Victoria, British Columbia, Canada
Cornwall, Ontario, Canada
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Waterloo, Ontario, Canada
Barcelona, , El Salvador
Bourg Des Comptes, , France
Dessenheim, , France
La Riche, , France
Paris, , France
Saint Avertin, , France
Savonnieres, , France
Tours, , France
Daejeon, , Korea, Republic Of
Deagu, , Korea, Republic Of
Goyang, , Korea, Republic Of
Seongnam, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Auckland, New Zealand, , New Zealand
Auckland, New Zealand, , New Zealand
Birkenhead Auckland, , New Zealand
Christchurch Central, , New Zealand
Christchurch, New Zealand, , New Zealand
Otahuhu Auckland, , New Zealand
Takapuna Auckland, , New Zealand
Tauranga, New Zealand, , New Zealand
Bergen, , Norway
Oslo, , Norway
Oslo, , Norway
Oslo, , Norway
Svelvik, , Norway
A Coruña, , Spain
Alicante, , Spain
Badía Del Vallès Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Sevilla, , Spain
Valencia, , Spain
Vic, , Spain
Kaohsiung, , Taiwan
Kaohsiung, , Taiwan
New Taipei, , Taiwan
Taichung, , Taiwan
Taichung, , Taiwan
Tainan, , Taiwan
Saint Louis, Missouri, United States
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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