A phase IIb, randomised, double-blind, placebo-controlled, parallel group, safety and efficacy study of BI 10773 (10 mg and 25 mg) administered orally, 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 glycaemic control.

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 14.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2009-013668-38-PT
• Lead Sponsor: Boehringer Ingelheim, Lda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-11
• Last Update Posted: 5 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 985

Inclusion Criteria

• 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 T2DM treated with basal glargine or detemir insulin (=20 IU/day) or NPH insulin (=14 IU/day) with or without concomitant metformin and / or sulfonylurea. The total insulin dose should not be changed by more than 10% of the baseline value within the 12 weeks prior to randomization. The oral anti-diabetic therapy has to be unchanged for at least 12 weeks prior to randomization.
• HbA1c of >7.0% and =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 =18 years at Visit 1 (screening)
• BMI =45 kg/m2 (Body Mass Index) at Visit 1 (screening)
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

Clinical conditions that might interfere with the subject's ability to participate in the trial include, but are not limited to, the following:
• Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast or >400 mg/dl (>22.2 mmol/L) in a randomly performed measurement during placebo run-in and confirmed by a second measurement (not on the same day).
• Frequent (at the discretion of the investigator) episodes of hypoglycemic events on
basal insulin therapy
• Myocardial infarction, stroke, or Transient Ischemic Attack (TIA) within 3 months
prior to obtaining informed consent
• Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST
(SGOT), or alkaline phosphatase (ALP) above 3 times the upper limit of normal
ULN) as determined at Visit 1
• Impaired renal function, defined as GFR <30 ml/min
• The metformin or sulfonylurea that you’re taking is not being used in accordance with local prescribing information.
• Any contraindications to the background basal insulin (glargine, detemir, or NPH)
according to the local label
• Known hypersensitivity or allergy to the investigational product BI 10773 or its
excipients
• Treatment with any other oral anti-diabetic medications, other than metformin and / or sulfonylurea therapy, within 3 months of obtaining informed consent
• Patients with a history of having received chronic short acting insulin, a
Glycogen-like peptide – 1 (GLP-1) analogue, or an Amylin agonist, within 3 months
of signing informed consent
• Gastric bypass surgery or any other gastrointestinal surgery that may induce
mal-absorption
• Treatment with anti-obesity drugs (e.g., including but not limited to sibutramine,
orlistat, or rimonabant) 3 months prior to informed consent
• Current treatment with systemic steroids at time of informed consent or change in
dosage of thyroid hormones within 6 weeks prior to informed consent
• Patients with history of any cancer within last 5 years with the exception of basal cell and squamous cell skin cancer
• Pre-menopausal women (last menstruation =1 year prior to informed consent) who: are nursing their infant or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study
• Alcohol or drug abuse within the 3 months prior to informed consent that would
interfere with trial participation
• Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., hemolytic anemia, thalassemias, sickle cell disease, hemochromatosis with routine phlebotomy treatment, malaria). An accurate HbA1c can not be established in patients with hemolysis
• Participation in another trial with an investigational drug within 2 months prior to
informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified