Completed

Linagliptin and Empagliflozin Combination for Improved Glycemic Control in Type 2 Diabetes Mellitus Patients

Study Aim

This study aims to evaluate the effectiveness of a combination treatment using Linagliptin and Empagliflozin in improving glycemic control, measured by the change in HbA1c levels after 24 weeks, in patients with Type 2 Diabetes Mellitus.

What is being tested

BI 10773

+ BI 10773 / BI 1356 Placebo

+ BI 10773 Placebo

Drug

Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: January 2013

See protocol details

Summary

Principal SponsorBoehringer Ingelheim

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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.

Official TitleA 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

Principal SponsorBoehringer Ingelheim

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

708 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

6 inclusion criteria required to participate

Signed and dated ICF (Informed Consent Form)

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

HBA1c (Glicoslated Hemoglobin) > or equal to 8% and < or equal to 10.5 % at Visit 1

HbA1c > or equal to 7 and < or equal to 10.5 at Visit 4

Show More Criteria

8 exclusion criteria prevent from participating

Uncontrolled hyperglycemia during open label period and placebo add on "run-in" period

Use of any other antidiabetic

Renal function below 60 ml/min/1.73 m2

Antiobesity drugs or aggresive diets

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

8 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in

Group II

Experimental

Empagliflozin / Linagliptin 10/5 mg Dose FDC active

Group III

Experimental

Empagliflozin / Linagliptin 25/5 mg Dose FDC active

Group IV

Experimental

Empagliflozin open label treatment period

Group 5

Experimental

Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in

Group 6

Experimental

Empagliflozin open label treatment period

Group 7

Experimental

Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo

Group 8

Experimental

Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 114 locations

Suspended

1275.10.01019 Boehringer Ingelheim Investigational Site

Chino, United StatesOpen 1275.10.01019 Boehringer Ingelheim Investigational Site in Google Maps

Suspended

1275.10.01008 Boehringer Ingelheim Investigational Site

Huntington Beach, United States

Suspended

1275.10.01003 Boehringer Ingelheim Investigational Site

San Diego, United States

Suspended

1275.10.01024 Boehringer Ingelheim Investigational Site

San Diego, United States

Completed114 Study Centers