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Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase III, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Linagliptin 5 mg Compared to Placebo, Administered as Oral Fixed Dose Combination With Empagliflozin 10 mg or 25 mg for 24 Weeks, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks of Treatment With Empagliflozin 10 mg or 25 mg on Metformin Background Therapy

NCT01778049•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (114)

1275.10.01019 Boehringer Ingelheim Investigational Site

Chino, California, United States

1275.10.01008 Boehringer Ingelheim Investigational Site

Huntington Beach, California, United States

1275.10.01003 Boehringer Ingelheim Investigational Site

San Diego, California, United States

1275.10.01024 Boehringer Ingelheim Investigational Site

San Diego, California, United States

1275.10.01002 Boehringer Ingelheim Investigational Site

Sylmar, California, United States

1275.10.01011 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

1275.10.01009 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

1275.10.01023 Boehringer Ingelheim Investigational Site

Oviedo, Florida, United States

1275.10.01006 Boehringer Ingelheim Investigational Site

Tamarac, Florida, United States

1275.10.01017 Boehringer Ingelheim Investigational Site

Conyers, Georgia, United States

Key Dates

Start Date

January 1, 2013

Primary Completion Date

March 1, 2015

Completion Date

March 1, 2015

Last Updated

April 4, 2016

Enrollment

708

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

BI 10773

DRUG

BI 10773 Placebo

DRUG

BI 10773 / BI 1356

DRUG

BI 10773

DRUG

BI 10773 / BI 1356

DRUG

BI 10773 / BI 1356 Placebo

DRUG

BI 10773

DRUG

BI 10773

DRUG

BI 10773

DRUG

BI 10773 / BI 1356 Placebo

DRUG

BI 10773 Placebo

DRUG

BI 10773 / BI 1356 Placebo

DRUG

BI 10773

DRUG

BI 10773 / BI 1356 Placebo

DRUG

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NCT06959901

Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

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RECRUITINGNA

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

NCT06574035

Diabetes Mellitus, Type 2Depressive Symptoms+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes

Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use

Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)