Completed

BI 10773 Safety and Efficacy in Type 2 Diabetes Treatment

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Study Aim

This phase 2 study aims to evaluate the safety and effectiveness of BI 10773 in treating type 2 diabetes, focusing on changes in lipid parameters, physical examination, vital signs, ECG and laboratory measurements, and hypoglycaemic events over a period of 78 weeks.

What is being tested

BI 10773

+ Metformin

+ Sitagliptin

Drug
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2009
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: March 1, 2009

Actual date on which the first participant was enrolled.

The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

Official TitleA 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients
NCT00881530
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

660 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

2 inclusion criteria required to participate
patients completing one of double blind phase II trials 1245.9 or 1245.10
informed consent
6 exclusion criteria prevent from participating
patients meeting withdrawal criteria of preceding trial
significant hepatic impairment
significant renal impairment with creatinine clearance < 50 ml/min
contraindication to Metformin for all patients treated with Metformin
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

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
higher dose

Group II

Active Comparator
2000 mg

Group III

Experimental
lower dose

Group IV

Active Comparator
100 mg

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 137 locations

Suspended

1245.24.101001 Boehringer Ingelheim Investigational Site

Mission Viejo, United StatesOpen 1245.24.101001 Boehringer Ingelheim Investigational Site in Google Maps
Suspended

1245.24.101028 Boehringer Ingelheim Investigational Site

Spring Valley, United States
Suspended

1245.24.101027 Boehringer Ingelheim Investigational Site

Walnut Creek, United States
Suspended

1245.24.101004 Boehringer Ingelheim Investigational Site

Clearwarter, United States
Completed137 Study Centers