Diabetes Mellitus, Type 2Phase 2NCT01011868

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

A Phase 2 study testing BI 10773 low dose and BI 10773 high dose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 99 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: BI 10773 low dose and BI 10773 high dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 494 participants
Where: 99 sitesin 7 countries
Study dates: Nov 2009to May 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation
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.
Glycosylated hemoglobin A1c (Type A, subtype 1c) of >7.0% and < or = 10% at Visit 1 (screening)
Suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study)
Age > or =18 years at Visit 1 (screening)
BMI < or = 45 kg/m2 (Body Mass Index) at Visit 1 (screening)

Who cannot join

Patients with poorly controlled hyperglycemia
Frequent (at the discretion of the investigator) episodes of hypoglycemic events on basal insulin therapy
MI, stroke, or TIA within 3 months prior to obtaining informed consent
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

Trial locations and contacts

99 sites in 7 countries.

Country

City, postcode or hospital

99 sites in 7 countries

United States56 sites

1245.33.01018 Boehringer Ingelheim Investigational Site
Altoona, Pennsylvania
1245.33.01027 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
1245.33.01014 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1245.33.01046 Boehringer Ingelheim Investigational Site
Bradednton, Florida
1245.33.01050 Boehringer Ingelheim Investigational Site
Brooksville, Florida
1245.33.01041 Boehringer Ingelheim Investigational Site
Carlisle, Pennsylvania
1245.33.01020 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1245.33.01044 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1245.33.01059 Boehringer Ingelheim Investigational Site
Chiefland, Florida
1245.33.01025 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1245.33.01028 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1245.33.01001 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1245.33.01023 Boehringer Ingelheim Investigational Site
Dallas, Texas
1245.33.01030 Boehringer Ingelheim Investigational Site
Dallas, Texas
1245.33.01040 Boehringer Ingelheim Investigational Site
Decatur, Georgia
1245.33.01054 Boehringer Ingelheim Investigational Site
Denver, Colorado
1245.33.01024 Boehringer Ingelheim Investigational Site
Des Moines, Iowa
1245.33.01045 Boehringer Ingelheim Investigational Site
Eugene, Oregon
1245.33.01010 Boehringer Ingelheim Investigational Site
Federal Way, Washington
1245.33.01029 Boehringer Ingelheim Investigational Site
Fleming Island, Florida
1245.33.01060 Boehringer Ingelheim Investigational Site
Fresno, California
1245.33.01007 Boehringer Ingelheim Investigational Site
Greensboro, North Carolina
1245.33.01004 Boehringer Ingelheim Investigational Site
Greer, South Carolina
1245.33.01048 Boehringer Ingelheim Investigational Site
Hollywood, Florida
1245.33.01006 Boehringer Ingelheim Investigational Site
Houston, Texas
1245.33.01011 Boehringer Ingelheim Investigational Site
Houston, Texas
1245.33.01003 Boehringer Ingelheim Investigational Site
Jacksonville, North Carolina
1245.33.01032 Boehringer Ingelheim Investigational Site
Kansas City, Missouri
1245.33.01058 Boehringer Ingelheim Investigational Site
Kingsport, Tennessee
1245.33.01042 Boehringer Ingelheim Investigational Site
Landsdale, Pennsylvania
1245.33.01043 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
1245.33.01062 Boehringer Ingelheim Investigational Site
Lawrenceville, Georgia
1245.33.01013 Boehringer Ingelheim Investigational Site
Los Angeles, California
1245.33.01008 Boehringer Ingelheim Investigational Site
Los Gatos, California
1245.33.01037 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
1245.33.01061 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin
1245.33.01036 Boehringer Ingelheim Investigational Site
Mt. Pleasant, South Carolina
1245.33.01019 Boehringer Ingelheim Investigational Site
National City, California
1245.33.01051 Boehringer Ingelheim Investigational Site
New Hartford, New York
1245.33.01033 Boehringer Ingelheim Investigational Site
New Port Richey, Florida
1245.33.01015 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
1245.33.01056 Boehringer Ingelheim Investigational Site
Olive Branch, Mississippi
1245.33.01017 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
1245.33.01055 Boehringer Ingelheim Investigational Site
Paramount, California
1245.33.01047 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1245.33.01009 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1245.33.01022 Boehringer Ingelheim Investigational Site
Saint Louis, Maryland
1245.33.01016 Boehringer Ingelheim Investigational Site
Salisbury, North Carolina
1245.33.01049 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
1245.33.01012 Boehringer Ingelheim Investigational Site
Santa Ana, California
1245.33.01035 Boehringer Ingelheim Investigational Site
Seneca, South Carolina
1245.33.01005 Boehringer Ingelheim Investigational Site
Statesville, North Carolina
1245.33.01002 Boehringer Ingelheim Investigational Site
Sugar Land, Texas
1245.33.01031 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma
1245.33.01038 Boehringer Ingelheim Investigational Site
Wilmington, North Carolina
1245.33.01026 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

United Kingdom10 sites

1245.33.44001 Boehringer Ingelheim Investigational Site
Bath
1245.33.44003 Boehringer Ingelheim Investigational Site
Birmingham
1245.33.44006 Boehringer Ingelheim Investigational Site
Blackburn
1245.33.44005 Boehringer Ingelheim Investigational Site
Dorking
1245.33.44009 Boehringer Ingelheim Investigational Site
Headington
1245.33.44008 Boehringer Ingelheim Investigational Site
Leicester
1245.33.44004 Boehringer Ingelheim Investigational Site
Liverpool
1245.33.44007 Boehringer Ingelheim Investigational Site
Wembley
1245.33.44002 Boehringer Ingelheim Investigational Site
Whitstable
1245.33.44010 Boehringer Ingelheim Investigational Site
Wymondham

Other trials in United Kingdom

France9 sites

1245.33.3301A Boehringer Ingelheim Investigational Site
Bondy
1245.33.3302A Boehringer Ingelheim Investigational Site
Corbeil-Essonnes
1245.33.3305A Boehringer Ingelheim Investigational Site
La Rochelle
1245.33.3306A Boehringer Ingelheim Investigational Site
Marseille
1245.33.3308A Boehringer Ingelheim Investigational Site
Montbrison
1245.33.3309A Boehringer Ingelheim Investigational Site
Nanterre
1245.33.3310A Boehringer Ingelheim Investigational Site
Nantes
1245.33.3304A Boehringer Ingelheim Investigational Site
Narbonne
1245.33.3303A Boehringer Ingelheim Investigational Site
Saint-Mandé

Other trials in France

Denmark8 sites

1245.33.45006 Boehringer Ingelheim Investigational Site
Aalborg
1245.33.45001 Boehringer Ingelheim Investigational Site
Aarhus C
1245.33.45011 Boehringer Ingelheim Investigational Site
Aarhus C
1245.33.45013 Boehringer Ingelheim Investigational Site
Aarhus C
1245.33.45004 Boehringer Ingelheim Investigational Site
Gentofte Municipality
1245.33.45008 Boehringer Ingelheim Investigational Site
Hillerød
1245.33.45002 Boehringer Ingelheim Investigational Site
Hvidovre
1245.33.45003 Boehringer Ingelheim Investigational Site
København NV

Other trials in Denmark

South Korea8 sites

1245.33.82008 Boehringer Ingelheim Investigational Site
Daejeon
1245.33.82007 Boehringer Ingelheim Investigational Site
Gwangju
1245.33.82001 Boehringer Ingelheim Investigational Site
Seoul
1245.33.82003 Boehringer Ingelheim Investigational Site
Seoul
1245.33.82004 Boehringer Ingelheim Investigational Site
Seoul
1245.33.82005 Boehringer Ingelheim Investigational Site
Seoul
1245.33.82006 Boehringer Ingelheim Investigational Site
Wŏnju
1245.33.82002 Boehringer Ingelheim Investigational Site
Yangsan

Other trials in South Korea

Portugal5 sites

1245.33.35104 Boehringer Ingelheim Investigational Site
Aveiro
1245.33.35101 Boehringer Ingelheim Investigational Site
Coimbra
1245.33.35102 Boehringer Ingelheim Investigational Site
Lisbon
1245.33.35106 Boehringer Ingelheim Investigational Site
Lisbon
1245.33.35107 Boehringer Ingelheim Investigational Site
Lisbon

Other trials in Portugal

Ireland3 sites

1245.33.35302 Boehringer Ingelheim Investigational Site
Dublin
1245.33.35303 Boehringer Ingelheim Investigational Site
Dublin
1245.33.35304 Boehringer Ingelheim Investigational Site
Dublin

Other trials in Ireland

About this study

Official title: 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

Conditions: Diabetes Mellitus, Type 2
Being tested: BI 10773 placebo, BI 10773 low dose, BI 10773 high dose
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 10773 placeboDrug
BI 10773 placebo
BI 10773 low doseDrug
BI 10773 low dose
BI 10773 high doseDrug
BI 10773 high dose
BI 10773 placeboDrug
BI 10773 placebo

Study groups in NCT01011868
Study group	Role	What they receive
BI 10773 low dose	Experimental	Patients receive BI 10773 low dose daily Receives: Drug: BI 10773 low dose
BI 10773 high dose	Experimental	Patients receive BI 10773 high dose daily Receives: Drug: BI 10773 placebo; Drug: BI 10773 high dose
placebo	Placebo comparator	Patients receive placebo to match BI 10773 daily Receives: Drug: BI 10773 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment
Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment
Measured: Baseline and 18 weeks

Secondary outcomes (8)

Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment
Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment
Measured: Baseline and 18, 54 and 78 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment
Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment
Measured: Baseline, 18, 54 and 78 weeks
Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment
Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment
Measured: Baseline, 18, 54 and 78 weeks
Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment
Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment
Measured: Baseline, 54 and 78 weeks
Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment
Change from baseline in body weight after 18, 54 and 78 weeks of treatment
Measured: Baseline, 18, 54, 78 weeks
Change From Baseline in Body Weight at Follow-up
Change from baseline in body weight at follow up (82 weeks)
Measured: Baseline and 82 weeks
Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment
Change from baseline in HbA1c after 54 and 78 weeks of treatment
Measured: 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
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
Measured: Baseline, 18, 54 and 78 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009May 2012

First posted11 Nov 2009 (estimated)
Study startNov 2009
Primary completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 494 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01011868
Sponsor's protocol ID: 1245.33
Other IDs: 2009-013668-38, 2009
Status last verified: Sep 2014
First submitted: 10 Nov 2009
Last updated: 30 Sep 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
PubMed 35472672

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01011868
Acronym / sponsor ID: 1245.33
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 494 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Nov 2009
Primary completion: May 2012 (actual)
First posted: 11 Nov 2009 (estimated)
Results: Posted 30 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
BI 10773 low dose	Experimental	Drug: BI 10773 low dosePatients receive BI 10773 low dose daily
BI 10773 high dose	Experimental	Drug: BI 10773 placebo, Drug: BI 10773 high dosePatients receive BI 10773 high dose daily
placebo	Placebo comparator	Drug: BI 10773 placeboPatients receive placebo to match BI 10773 daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation
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.
Glycosylated hemoglobin A1c (Type A, subtype 1c) of >7.0% and < or = 10% at Visit 1 (screening)
Suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study)
Age > or =18 years at Visit 1 (screening)

Key exclusion criteria (5 listed)

Patients with poorly controlled hyperglycemia
Frequent (at the discretion of the investigator) episodes of hypoglycemic events on basal insulin therapy
MI, stroke, or TIA within 3 months prior to obtaining informed consent
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 10773 placeboBI 10773 placebo	Drug	BI 10773 high dose
BI 10773 low doseBI 10773 low dose	Drug	BI 10773 low dose
BI 10773 high doseBI 10773 high dose	Drug	BI 10773 high dose
BI 10773 placeboBI 10773 placebo	Drug	placebo

Primary outcome

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

8 secondary outcomes

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
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
Time frame: 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 Body Weight After 18, 54 and 78 Weeks of Treatment
Time frame: Baseline, 18, 54, 78 weeks
Change From Baseline in Body Weight at Follow-up
Time frame: Baseline and 82 weeks
Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment
Time frame: 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

Results and safety

Results posted to the registry on 30 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	170	147
Empagliflozin 10 mg	169	153
Empagliflozin 25 mg	155	129

Primary outcome: Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment

Time frame: Baseline and 18 weeks. Mean (Standard Error). Unit: percentage of HbA1c

Measure	Placebo n = 125	Empagliflozin 10 mg n = 132	Empagliflozin 25 mg n = 117
Value	0.03 (0.07)	-0.58 (0.07)	-0.75 (0.08)

Placebo vs Empagliflozin 10 mg: Adjusted mean difference: -0.56 (97.5% CI -0.78 to -0.33), p <0.0001, ANCOVA
Placebo vs Empagliflozin 25 mg: Adjusted mean difference: -0.70 (97.5% CI -0.93 to -0.47), p <0.0001, ANCOVA

Population analysed: FAS18-completers-included FAS patients not prematurely discontinue prior to Week 18, completed required minimum treatment duration, and had an on treatment HbA1c value within Week 18 time window. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF-18) was used for imputation. (LOCF-18)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the course of the study (82 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	28 of 170 (16.5%)	115 of 170 (67.6%)	Not reported
Empagliflozin 10 mg	28 of 169 (16.6%)	110 of 169 (65.1%)	Not reported
Empagliflozin 25 mg	28 of 155 (18.1%)	95 of 155 (61.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35472672Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

99 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 10773 low dose and BI 10773 high dose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 99 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, United Kingdom, France, Denmark, South Korea and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment (time frame: Baseline and 18 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01011868, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2014.