A Phase II, randomized, parallel group safety, efficacy, and pharmacokinetics study of BI 10773 (1mg, 5mg, 10mg, 25mg, and 50mg) administered orally once daily over 12 weeks compared double blind to placebo with an additional open-label sitagliptin arm in type 2 diabetic patients with insufficient glycemic control despite metformin therapyEstudio de fase II, doble ciego, aleatorizado, de grupos paralelos, para evaluar la seguridad, eficacia y farmacocinética de BI 10773 (1 mg, 5 mg, 10 mg, 25 mg y 50 mg) administrado una vez al día por vía oral durante 12 semanas, comparado con placebo y con un brazo abierto adicional con sitagliptina, en pacientes con Diabetes Mellitus tipo 2 con un control insuficiente de la glucemia a pesar del tratamiento con metformina

Conditions: Type 2 diabetes mellitusDiabetes Mellitus tipo 2
MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

Registration Number: EUCTR2008-000641-54-ES

Lead Sponsor: Boehringer Ingelheim España, S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 448

Inclusion Criteria

1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug other than those described in the Exclusion Criteria (antidiabetic therapy has to be unchanged for at least 10 weeks prior to screening);
2. Stable metformin therapy:
a. a dose of ≥1500 mg/day metformin;
b. in patients with a total daily dose of less than 1500 mg metformin, inclusion will only be possible if the investigator has documented them to be on their maximum tolerated dose;
c. therapy needs to be stable for at least 10 weeks prior to screening
3. Glycosylated hemoglobin A1 (HbA1c) at Visit 1A (Screening)
a. for patients treated with metformin and one additional oral antidiabetic drug: HbA1c ≥6.5 to ≤9.0%;
b. for patients treated with metformin only: HbA1c >7.0 to ≤10.0%
4. Glycosylated hemoglobin A1 (HbA1c) >7.0 to ≤10.0% at Visit 2 (Start of Run-in)
5. Age ≥18 and <80years
6. Body Mass Index (BMI) ≤40 kg/m2
7. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent;
2. Impaired hepatic function, defined by serum levels of either alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), or alkaline phosphatase above 3 times the upper limit of normal (ULN);
3. Renal insufficiency or impaired renal function defined by creatinine clearance <50 mL/min or serum creatinine levels men ≥1.5 mg/dL ; women ≥1.4 mg/dL at screening;
4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurological disorders (including cerebrovascular disease and polyneuropathy) that may interfere with participation in the trial;
5. Chronic or clinically relevant acute infections (e.g., human immunodeficiency virus, hepatitis);
6. Current or chronic urogenital tract infection determined by medical history
7. History of clinically relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients);
8. Treatment with any of the following anti-diabetic treatments within 3 months prior to informed consent:
a. glitazones (e.g., rosiglitazone, pioglitazone),
b. glucagon-like peptide (GLP-1) analogues
c. insulin
9. Treatment with anti-obesity drugs (e.g., sibutramine, orlistat, rimonabant) within 3 months prior to informed consent;
10. Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent;
11. Alcohol abuse within the last 3 months that would interfere with trial participation or drug abuse;
12. Treatment with an investigational drug within 2 months prior to informed consent
13. Women of child-bearing potential who:
a. are nursing or pregnant, or
b. are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during participation in the trial.