NCT00558571

Brief Summary

Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P75+ for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

August 7, 2014

Completed
Last Updated

August 7, 2014

Status Verified

July 1, 2014

Enrollment Period

3 months

First QC Date

November 14, 2007

Results QC Date

May 16, 2014

Last Update Submit

July 16, 2014

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects With Drug Related Adverse Events

    number of subjects with investigator-defined drug-related adverse events.

    from drug administration up to 6 weeks

  • Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG

    Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

    from drug administration up to 6 weeks

Secondary Outcomes (17)

  • Cmax of Empagliflozin

    0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 hours(h) after drug administration on day 1 and 28

  • Tmax of Empagliflozin

    0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28

  • t1/2 of Empagliflozin

    0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28

  • AUC0-∞ of Empagliflozin

    0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1

  • CL/F of Empaglifozin

    0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28

  • +12 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Drug: placebo to BI 10773

BI 10773 low dose

EXPERIMENTAL
Drug: BI 10773 low dose

BI 10773 medium dose

EXPERIMENTAL
Drug: BI 10773 medium dose

BI 10773 high dose

EXPERIMENTAL
Drug: BI 10773 high dose

Interventions

BI 10773 low doseDRUG
BI 10773 low dose
placebo to BI 10773DRUG
Placebo
BI 10773 medium doseDRUG
BI 10773 medium dose
BI 10773 high doseDRUG
BI 10773 high dose

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and postmenopausal or hysterectomised female patients with type 2 diabetes
  • Age \>18 and \< 70 years
  • BMI \>18.5 and \<40 kg/m2

You may not qualify if:

  • Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent;
  • Fasted blood glucose \> 240 mg/dl (\>13.3 mmol/L) or a blood glucose level above 400 mg/dl (22.2 mmol/L) postprandially;
  • HbA1c \> 8.5 %

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

1245.4.49003 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1245.4.49002 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1245.4.49001 Boehringer Ingelheim Investigational Site

Neuss, Germany

Location

Related Publications (2)

  • 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.

    PMID: 35472672DERIVED

  • Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13.

    PMID: 23940010DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2007

First Posted

November 15, 2007

Study Start

January 1, 2008

Primary Completion

April 1, 2008

Last Updated

August 7, 2014

Results First Posted

August 7, 2014

Record last verified: 2014-07

Locations

DE(3)