Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes

September 24, 2014 updated by: Boehringer Ingelheim

A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety and Efficacy Study of BI 10773 (10 mg and 25 mg) Administered Orally, Once Daily Over 78 Weeks in Type 2 Diabetic Patients Receiving Treatment With Basal Insulin (Glargine, Detemir, or NPH Insulin Only) With or Without Concomitant Metformin and/or Sulfonylurea Therapy and Insufficient Glycemic Control

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
494

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • 1245.33.45006 Boehringer Ingelheim Investigational Site
      • Aarhus C, Denmark
        • 1245.33.45001 Boehringer Ingelheim Investigational Site
      • Aarhus C, Denmark
        • 1245.33.45011 Boehringer Ingelheim Investigational Site
      • Aarhus C, Denmark
        • 1245.33.45013 Boehringer Ingelheim Investigational Site
      • Gentofte, Denmark
        • 1245.33.45004 Boehringer Ingelheim Investigational Site
      • Hillerød, Denmark
        • 1245.33.45008 Boehringer Ingelheim Investigational Site
      • Hvidovre, Denmark
        • 1245.33.45002 Boehringer Ingelheim Investigational Site
      • København NV, Denmark
        • 1245.33.45003 Boehringer Ingelheim Investigational Site
  • France
      • Bondy Cedex, France
        • 1245.33.3301A Boehringer Ingelheim Investigational Site
      • Corbeil Essonnes, France
        • 1245.33.3302A Boehringer Ingelheim Investigational Site
      • La Rochelle Cedex 1, France
        • 1245.33.3305A Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 1245.33.3306A Boehringer Ingelheim Investigational Site
      • Montbrison, France
        • 1245.33.3308A Boehringer Ingelheim Investigational Site
      • Nanterre Cedex, France
        • 1245.33.3309A Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1245.33.3310A Boehringer Ingelheim Investigational Site
      • Narbonne Cedex, France
        • 1245.33.3304A Boehringer Ingelheim Investigational Site
      • Saint Mandé, France
        • 1245.33.3303A Boehringer Ingelheim Investigational Site
  • Ireland
      • Dublin, Ireland
        • 1245.33.35302 Boehringer Ingelheim Investigational Site
      • Dublin, Ireland
        • 1245.33.35303 Boehringer Ingelheim Investigational Site
      • Dublin, Ireland
        • 1245.33.35304 Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Daejeon, Korea, Republic of
        • 1245.33.82008 Boehringer Ingelheim Investigational Site
      • Gwangju, Korea, Republic of
        • 1245.33.82007 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1245.33.82001 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1245.33.82003 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1245.33.82004 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1245.33.82005 Boehringer Ingelheim Investigational Site
      • Wonju, Korea, Republic of
        • 1245.33.82006 Boehringer Ingelheim Investigational Site
      • Yangsan, Korea, Republic of
        • 1245.33.82002 Boehringer Ingelheim Investigational Site
  • Portugal
      • Aveiro, Portugal
        • 1245.33.35104 Boehringer Ingelheim Investigational Site
      • Coimbra, Portugal
        • 1245.33.35101 Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • 1245.33.35102 Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • 1245.33.35106 Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • 1245.33.35107 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Bath, United Kingdom
        • 1245.33.44001 Boehringer Ingelheim Investigational Site
      • Birmingham, United Kingdom
        • 1245.33.44003 Boehringer Ingelheim Investigational Site
      • Blackburn, United Kingdom
        • 1245.33.44006 Boehringer Ingelheim Investigational Site
      • Dorking, United Kingdom
        • 1245.33.44005 Boehringer Ingelheim Investigational Site
      • Headington, United Kingdom
        • 1245.33.44009 Boehringer Ingelheim Investigational Site
      • Leicester, United Kingdom
        • 1245.33.44008 Boehringer Ingelheim Investigational Site
      • Liverpool, United Kingdom
        • 1245.33.44004 Boehringer Ingelheim Investigational Site
      • Wembley, United Kingdom
        • 1245.33.44007 Boehringer Ingelheim Investigational Site
      • Whitstable, United Kingdom
        • 1245.33.44002 Boehringer Ingelheim Investigational Site
      • Wymondham, United Kingdom
        • 1245.33.44010 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 1245.33.01014 Boehringer Ingelheim Investigational Site
    • Arizona
      • Phoenix, Arizona, United States
        • 1245.33.01047 Boehringer Ingelheim Investigational Site
    • California
      • Fresno, California, United States
        • 1245.33.01060 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 1245.33.01013 Boehringer Ingelheim Investigational Site
      • Los Gatos, California, United States
        • 1245.33.01008 Boehringer Ingelheim Investigational Site
      • National City, California, United States
        • 1245.33.01019 Boehringer Ingelheim Investigational Site
      • Paramount, California, United States
        • 1245.33.01055 Boehringer Ingelheim Investigational Site
      • Santa Ana, California, United States
        • 1245.33.01012 Boehringer Ingelheim Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • 1245.33.01054 Boehringer Ingelheim Investigational Site
    • Florida
      • Bradednton, Florida, United States
        • 1245.33.01046 Boehringer Ingelheim Investigational Site
      • Brooksville, Florida, United States
        • 1245.33.01050 Boehringer Ingelheim Investigational Site
      • Chiefland, Florida, United States
        • 1245.33.01059 Boehringer Ingelheim Investigational Site
      • Clearwater, Florida, United States
        • 1245.33.01028 Boehringer Ingelheim Investigational Site
      • Fleming Island, Florida, United States
        • 1245.33.01029 Boehringer Ingelheim Investigational Site
      • Hollywood, Florida, United States
        • 1245.33.01048 Boehringer Ingelheim Investigational Site
      • New Port Richey, Florida, United States
        • 1245.33.01033 Boehringer Ingelheim Investigational Site
    • Georgia
      • Atlanta, Georgia, United States
        • 1245.33.01027 Boehringer Ingelheim Investigational Site
      • Decatur, Georgia, United States
        • 1245.33.01040 Boehringer Ingelheim Investigational Site
      • Lawrenceville, Georgia, United States
        • 1245.33.01062 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • 1245.33.01020 Boehringer Ingelheim Investigational Site
      • Chicago, Illinois, United States
        • 1245.33.01044 Boehringer Ingelheim Investigational Site
    • Iowa
      • Des Moines, Iowa, United States
        • 1245.33.01024 Boehringer Ingelheim Investigational Site
    • Maryland
      • St. Louis, Maryland, United States
        • 1245.33.01022 Boehringer Ingelheim Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States
        • 1245.33.01056 Boehringer Ingelheim Investigational Site
    • Missouri
      • Kansas City, Missouri, United States
        • 1245.33.01032 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • 1245.33.01017 Boehringer Ingelheim Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • 1245.33.01043 Boehringer Ingelheim Investigational Site
    • New York
      • New Hartford, New York, United States
        • 1245.33.01051 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States
        • 1245.33.01007 Boehringer Ingelheim Investigational Site
      • Jacksonville, North Carolina, United States
        • 1245.33.01003 Boehringer Ingelheim Investigational Site
      • Salisbury, North Carolina, United States
        • 1245.33.01016 Boehringer Ingelheim Investigational Site
      • Statesville, North Carolina, United States
        • 1245.33.01005 Boehringer Ingelheim Investigational Site
      • Wilmington, North Carolina, United States
        • 1245.33.01038 Boehringer Ingelheim Investigational Site
      • Winston-Salem, North Carolina, United States
        • 1245.33.01026 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 1245.33.01025 Boehringer Ingelheim Investigational Site
      • Columbus, Ohio, United States
        • 1245.33.01001 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • 1245.33.01031 Boehringer Ingelheim Investigational Site
    • Oregon
      • Eugene, Oregon, United States
        • 1245.33.01045 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States
        • 1245.33.01018 Boehringer Ingelheim Investigational Site
      • Carlisle, Pennsylvania, United States
        • 1245.33.01041 Boehringer Ingelheim Investigational Site
      • Landsdale, Pennsylvania, United States
        • 1245.33.01042 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Greer, South Carolina, United States
        • 1245.33.01004 Boehringer Ingelheim Investigational Site
      • Mt. Pleasant, South Carolina, United States
        • 1245.33.01036 Boehringer Ingelheim Investigational Site
      • Seneca, South Carolina, United States
        • 1245.33.01035 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States
        • 1245.33.01058 Boehringer Ingelheim Investigational Site
      • Memphis, Tennessee, United States
        • 1245.33.01037 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 1245.33.01023 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 1245.33.01030 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1245.33.01006 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1245.33.01011 Boehringer Ingelheim Investigational Site
      • Sugar Land, Texas, United States
        • 1245.33.01002 Boehringer Ingelheim Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • 1245.33.01049 Boehringer Ingelheim Investigational Site
    • Virginia
      • Norfolk, Virginia, United States
        • 1245.33.01015 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, United States
        • 1245.33.01009 Boehringer Ingelheim Investigational Site
    • Washington
      • Federal Way, Washington, United States
        • 1245.33.01010 Boehringer Ingelheim Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • 1245.33.01061 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation
  2. Male and female patients with a diagnosis of Type 2 Diabetes Mellitus treated with a stable dose of basal insulin with or without concomitant metformin and / or sulfonylurea.
  3. Glycosylated hemoglobin A1c (Type A, subtype 1c) of >7.0% and < or = 10% at Visit 1 (screening)
  4. Suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study)
  5. Age > or =18 years at Visit 1 (screening)
  6. BMI < or = 45 kg/m2 (Body Mass Index) at Visit 1 (screening)

Exclusion criteria:

  1. Patients with poorly controlled hyperglycemia
  2. Frequent (at the discretion of the investigator) episodes of hypoglycemic events on basal insulin therapy
  3. MI, stroke, or TIA within 3 months prior to obtaining informed consent
  4. Impaired hepatic or renal function; gastric surgery; cancer within the last 5 years; blood dyscrasias

6. Treatment with other anti-diabetics, anti-obesity medications, steroids or thyroid hormones, participation in another trial with an investigational drug 7. Pre-menopausal women on insufficient birth control 8. Alcohol or drug abuse

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BI 10773 low dose
Patients receive BI 10773 low dose daily
Drug: BI 10773 low dose
BI 10773 low dose
Experimental: BI 10773 high dose
Patients receive BI 10773 high dose daily
Drug: BI 10773 placebo
BI 10773 placebo
Drug: BI 10773 high dose
BI 10773 high dose
Placebo Comparator: placebo
Patients receive placebo to match BI 10773 daily
Drug: BI 10773 placebo
BI 10773 placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment
Time Frame: Baseline and 18 weeks
Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment
Baseline and 18 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment
Time Frame: Baseline and 18, 54 and 78 weeks
Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment
Baseline and 18, 54 and 78 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment
Time Frame: Baseline, 18, 54 and 78 weeks
Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment
Baseline, 18, 54 and 78 weeks
Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment
Time Frame: Baseline, 18, 54 and 78 weeks
Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment
Baseline, 18, 54 and 78 weeks
Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment
Time Frame: Baseline, 54 and 78 weeks
Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment
Baseline, 54 and 78 weeks
Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment
Time Frame: Baseline, 18, 54, 78 weeks
Change from baseline in body weight after 18, 54 and 78 weeks of treatment
Baseline, 18, 54, 78 weeks
Change From Baseline in Body Weight at Follow-up
Time Frame: Baseline and 82 weeks
Change from baseline in body weight at follow up (82 weeks)
Baseline and 82 weeks
Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment
Time Frame: Baseline, 54 and 78 weeks
Change from baseline in HbA1c after 54 and 78 weeks of treatment
Baseline, 54 and 78 weeks
The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment
Time Frame: Baseline, 18, 54 and 78 weeks
The occurrence of treat to target efficacy response, that is an HbA1c under treatment of <7.0% After 18, 54, and 78 weeks of treatment
Baseline, 18, 54 and 78 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Confirmed Hypoglycemic Events
Time Frame: During the course of the study (82 weeks)
Confirmed hypoglycemic events refer to all hypoglycemic events that had a glucose value ≤70 ml/dL or where assistance was required. Symptomatic hypoglycemic events were to be reported as adverse events. Investigator-defined hypoglycaemia adverse events include all events that investigator marked as 'Hypoglycaemic event' in CRFs, regardless of the reported term or blood glucose value. It may include hypoglycemia itself as reported term or any other symptoms that that investigator may have attributed to hypoglycemia (e.g. dizziness, hyperhidrosis, and asthenia).
During the course of the study (82 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1245.33
  • 2009-013668-38 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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