12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients

NCT00789035 | Completed Phase 2 Results

• 2 other identifiers: 1245.9EudraCT No 2008-000640-14
• Study Type: interventional
• Target: 408
• Locations: 13 countries
• Sites: 74

Brief Summary

The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment

  Change of HbA1c from baseline after 12 weeks of treatment. Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.

  Baseline and 12 weeks

Secondary Outcomes (9)

• Change of FPG From Baseline After 12 Weeks of Treatment

  Baseline and 12 weeks

• Change of HbA1c From Baseline Over Time

  Baseline and weeks 4, 8 and 12

• Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment

  12 weeks

• Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment

  12 weeks

• Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)

  Baseline and 12 weeks

Interventions

BI 10773 DRUG

placebo DRUG

metformin DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients with a diagnosis of type 2 diabetes mellitus
• either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose for the10 weeks prior to screening
• HbA1c ≥6.5 to ≤9.0% and for treatment-naïve patients:HbA1c \>7.0 to ≤10.0%
• HbA1c \>7.0 to ≤10.0% at Visit 2 (start of run-in) for all patients
• Age between 18 and 80 years
• BMI less than 40 kg/m2
• Signed and dated informed consent prior to admission to the study in accordance with GCP and local legislation

You may not qualify if:

• Myocardial infarction, stroke or TIA within 6 months prior to informed consent
• Impaired hepatic function
• Renal insufficiency or impaired renal function
• Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation
• Chronic or clinically relevant acute infections
• Current or chronic urogenital tract infection determined by medical history
• History of clinically relevant allergy/hypersensitivity
• Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent
• Treatment with anti obesity drugs
• Current treatment with systemic steroids
• Alcohol abuse
• Treatment with an investigational drug within 2 months prior to informed consent
• known intolerance to metformin
• Dehydration
• Unstable or acute CHF

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (74)

1245.9.54001 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1245.9.54002 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1245.9.54007 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1245.9.54008 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1245.9.54009 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1245.9.54010 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1245.9.54004 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

Location

1245.9.54003 Boehringer Ingelheim Investigational Site

Mendoza, Argentina

Location

1245.9.54005 Boehringer Ingelheim Investigational Site

Salta, Argentina

Location

1245.9.54006 Boehringer Ingelheim Investigational Site

Salta, Argentina

Location

1245.9.38504 Boehringer Ingelheim Investigational Site

Karlovac, Croatia

Location

1245.9.38503 Boehringer Ingelheim Investigational Site

Krapinske Toplice, Croatia

Location

1245.9.38506 Boehringer Ingelheim Investigational Site

Osijek, Croatia

Location

1245.9.38505 Boehringer Ingelheim Investigational Site

Varaždin, Croatia

Location

1245.9.38501 Boehringer Ingelheim Investigational Site

Zagreb, Croatia

Location

1245.9.37201 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1245.9.37202 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1245.9.37203 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1245.9.49007 Boehringer Ingelheim Investigational Site

Aschaffenburg, Germany

Location

1245.9.49001 Boehringer Ingelheim Investigational Site

Erlangen, Germany

Location

1245.9.49004 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1245.9.49005 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1245.9.49002 Boehringer Ingelheim Investigational Site

Melsungen, Germany

Location

1245.9.49008 Boehringer Ingelheim Investigational Site

Nuremberg, Germany

Location

1245.9.49003 Boehringer Ingelheim Investigational Site

Saint Ingbert/Oberwürzbach, Germany

Location

1245.9.49006 Boehringer Ingelheim Investigational Site

Sulzbach-Rosenberg, Germany

Location

1245.9.39006 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

1245.9.39001 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

1245.9.39003 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

1245.9.39004 Boehringer Ingelheim Investigational Site

Siena, Italy

Location

1245.9.39005 Boehringer Ingelheim Investigational Site

Treviso, Italy

Location

1245.9.37002 Boehringer Ingelheim Investigational Site

Klaipėda, Lithuania

Location

1245.9.37001 Boehringer Ingelheim Investigational Site

Vilnius, Lithuania

Location

1245.9.40003 Boehringer Ingelheim Investigational Site

Brasov, Romania

Location

1245.9.40002 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1245.9.40004 Boehringer Ingelheim Investigational Site

Galati, Romania

Location

1245.9.40005 Boehringer Ingelheim Investigational Site

Târgu Mureş, Romania

Location

1245.9.70002 Boehringer Ingelheim Investigational Site

Kazan', Russia

Location

1245.9.70003 Boehringer Ingelheim Investigational Site

Nizhny Novgorod, Russia

Location

1245.9.70004 Boehringer Ingelheim Investigational Site

Petrozavodsk, Russia

Location

1245.9.70005 Boehringer Ingelheim Investigational Site

Smolensk, Russia

Location

1245.9.70006 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

1245.9.70007 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

1245.9.70001 Boehringer Ingelheim Investigational Site

Yekaterinburg, Russia

Location

1245.9.62002 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1245.9.62003 Boehringer Ingelheim Investigational Site

Lučenec, Slovakia

Location

1245.9.62004 Boehringer Ingelheim Investigational Site

Nové Mesto nad Váhom, Slovakia

Location

1245.9.62001 Boehringer Ingelheim Investigational Site

Prievidza, Slovakia

Location

1245.9.82006 Boehringer Ingelheim Investigational Site

Goyang, South Korea

Location

1245.9.82008 Boehringer Ingelheim Investigational Site

Goyang, South Korea

Location

1245.9.82007 Boehringer Ingelheim Investigational Site

Incheon, South Korea

Location

1245.9.82002 Boehringer Ingelheim Investigational Site

Pucheon, South Korea

Location

1245.9.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1245.9.82004 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1245.9.82005 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1245.9.82009 Boehringer Ingelheim Investigational Site

Suwon, South Korea

Location

1245.9.82003 Boehringer Ingelheim Investigational Site

Uijeongbu-si, South Korea

Location

1245.9.46003 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1245.9.46004 Boehringer Ingelheim Investigational Site

Härnösand, Sweden

Location

1245.9.46005 Boehringer Ingelheim Investigational Site

Lund, Sweden

Location

1245.9.46001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1245.9.46002 Boehringer Ingelheim Investigational Site

Västerås, Sweden

Location

1245.9.88605 Boehringer Ingelheim Investigational Site

Changhua, Taiwan

Location

1245.9.88607 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

Location

1245.9.88604 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

1245.9.88606 Boehringer Ingelheim Investigational Site

Tainan, Taiwan

Location

1245.9.88601 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1245.9.88603 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1245.9.88602 Boehringer Ingelheim Investigational Site

Taoyuan District, Taiwan

Location

1245.9.38003 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1245.9.38004 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1245.9.38002 Boehringer Ingelheim Investigational Site

Odesa, Ukraine

Location

1245.9.38001 Boehringer Ingelheim Investigational Site

Vinnytsia, Ukraine

Location

1245.9.38005 Boehringer Ingelheim Investigational Site

Vinnytsia, Ukraine

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: 35472672 DERIVED

• 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: 23940010 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

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 2
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 13, 2008
• First Posted: November 11, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2009
• Last Updated: June 18, 2014
• Results First Posted: June 18, 2014

Record last verified: 2014-05

Locations

IT (5); RU (7); ES (3); LI (2); DE (8); AR (10); SL (4); RO (4); SE (5); CR (5); TW (7); UA (5); KR (9)