A randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 10773 (25 mg, administered orally once daily) compared to glimepiride (1 to 4 mg once daily) over two years, in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin therapy - Cascade 7
- Conditions
- Type 2 diabetes mellitus pre-treated with metforminMedDRA version: 12.1Level: LLTClassification code 10067585Term: Type 2 diabetes mellitus
- Registration Number
- EUCTR2009-016244-39-NO
- Lead Sponsor
- Boehringer Ingelheim Norway KS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2637
1. Diagnosis of type 2 diabetes mellitus prior to informed consent
2. Male and female patients on diet and exercise regimen who are pre-treated with a stable maximum tolerated dose of metformin unchanged for 12 weeks prior to randomisation. (Preferably >/= 1500mg/day metformin)
3. HbA1c of more than or equal to 7.0% and less or equal to 10.0% at Visit 1 (screening)
4. Age more than or equal to 18yrs
5. BMI more or than or equal to 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 metformin
3. Myocardial infarction, 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 at Visit 1
5. Impaired renal function, defined as eGFR<60 ml/min (moderate to severe impairment calculated using MDRD formula)
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. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
9. Contraindications including hypersensitivity known to metformin or sulfonylureas according to the local label
10. Treatment with glitazones, insulin or GLP- analogues or agonists 3 months prior to randomisation
11. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 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
12. 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. (Treatment with local and inhaled steroids is allowed)
13. Pre-menopausal women (last menstruation ? 1 year 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, double barrier method and vasectomised partner
14. 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
15. Participation in another trial with an investigational drug within 30 days prior to informed consent
16. 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
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the current study is to investigate the efficacy, safety and tolerability of BI10773 (25mg once daily) compared to glimepriride (1-4mg daily) given for 104 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin.;Secondary Objective: Key secondary endpoints:<br>1) Change in body weight from baseline after 52 weeks and 104 weeks of treatment.<br>2) The occurence of confirmed symptomatic hypoglycemic events during 52 weeks and 104 weeks.<br>3) Change in blood pressure ( SBP and DBP) from baseline after 52 weeks and 104 weeks. ;Primary end point(s): The change from baseline in HbA1c after 52 weeks and 104 weeks.
- Secondary Outcome Measures
Name Time Method