A phase III randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of BI 10773 (10 mg, 25 mg) administered orally, once daily over 24 weeks in patients with type 2 diabetes with insufficient glycaemic control despite treatment with metformin alone or metformin in combination with a sulfonylurea

• Conditions: The study will be performed in patients (age of 18 or more) with type 2 diabetes and insufficient glycaemic control despite a background therapy of metformin or metformin plus a sulfonylurea.; MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2009-016258-41-SI
• Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-23
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1390

Inclusion Criteria

1. Diagnosis of type 2 diabetes mellitus prior to informed consent
2. Male and female patients on a diet and exercise regimen who are pre-treated with immediate release metformin or immediate release metformin plus sulfonylurea
(see below for minimum doses).
The treatment regimen has to be unchanged for 12 weeks prior to randomisation.
Minimum dose for metformin: - > or = 1500 mg/day or
- maximum tolerated dose or
- maximum dose according to local label
Minimum dose for sulfonylurea: - > or = half of the maximal recommended dose or
- maximum tolerated dose or
- maximum dose according to local label
3. HbA1c of > or = 7.0% and < or = 10% at Visit 1 (screening) in order to be eligible for randomised treatment
HbA1c of > 10% at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773)
4. Age > or = 18
5. BMI < or = 45 kg/m2 (Body Mass Index) at Visit 1 (Screening)
6. Signed and dated written informed consent by date of Visit 1 in accordance with 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 890
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

Exclusion Criteria

1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
2. Any other antidiabetic drug within 12 weeks prior to randomisation except those mentioned in inclusion criterion 2
3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent
4. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase
5. Impaired renal function, defined as GFR<30 ml/min (severe renal impairment) during screening and/or run-in phase
6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
8. Contraindications to metformin and/or sulfonyurea according to the local label for those patients that enter the study with the respective background therapy
9. Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g.malaria, babesiosis, haemolytic anemia).
10. Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery,
aggressive diet regimen, etc.) leading to unstable body weight
11. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2D
12. Pre-menopausal women (last menstruation 1 year or less prior to informed consent) who: are nursing 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 and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence, (if acceptable by local authorities) double barrier method and vasectomised partner
13. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
14. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial
15. Any other clinical condition that would jeopardize patients safety while
participating in this clinical trial

Study & Design

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