A Multicenter, Randomized, Double Blind (Double Dummy), Active Controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Pioglitazone in Type 2 Diabetes Patients Inadequately Controlled on Therapy With Sulfonylurea or Metformin Plus Sulfonylurea
- Conditions
- -E11 Non-insulin-dependent diabetes mellitusNon-insulin-dependent diabetes mellitusE11
- Registration Number
- PER-065-09
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Men and women between the ages of 18 and 75 during the selection. Women of childbearing age who use an approved method of contraception (for example hormonal contraceptives, IUDs, barrier contraception) should be willing to use the same methods of contraception throughout the study.
• Patients with type II diabetes mellitus treated with stable sulfonylurea monotreatment or combination treatment with metformin plus sulfonylurea for a minimum period of 12 weeks before selection. Sulfonylurea (SU) needs to be at least half the maximum effective dose. The dose of metformin should be> 1500 mg / day (or the maximum dose tolerated individually), but not more than the maximum dose specified on the label.
• It should be agreed to reduce the dose of SU at the time of randomization (before the start of the treatment under study) to the minimum dose available.
• HbA1c:> 7.0% and <10% at the time of the election.
• body mass index (BMI)> 25 (> 23 for Asians) and <45 kg / m2 at the time of selection.
• Stable weight ± 5% for a minimum period of 12 weeks before selection.
• It must be accepted to maintain the previous diet and previous exercise habits throughout the study.
• Ability and willingness to sign informed consent in writing and meet the requirements of the study.
• Pregnant women, who plan to get pregnant during the study period or who are currently breastfeeding.
• Diagnosis or history of: Type 1 diabetes. Diabetes resulting from pancreatic injury or secondary forms of diabetes, for example acromegaly and Cushing´s syndrome. Complications of acute metabolic diabetes, for example ketoacidosis or hyperosmolar coma in the last 6 months.
• Evidence of clinically significant diabetic complications, for example known proliferative retinopathy.
• Clinically symptomatic gastrointestinal disease, which includes among others inflammatory bowel disease, celiac disease, diabetic gastroparesis and cholelithiasis.
• History of bariatric surgery for example gastric bypass or antrectomy or removal of the small or large intestine.
• History of chronic pancreatitis or idiopathic acute pancreatitis.
• Record of more than 3 episodes of severe hypoglycemia (defined as the need for another person´s assistance) in a period of 6 months before selection.
• Any abnormality in clinical laboratory tests or ECG, which prevents safe participation in the study at the discretion of the Investigator.
• Prolongation of clinically relevant QTc (for example QTc> 480 ms), military history of Long QT syndrome, or concomitant use of class I antiarrhythmics (for example disopyramide, quinidine, procainamide, mexiletine, flecainide, propafenone)
• Malignant neoplasm diagnosed and / or treated (except for basal cell skin cancer, carcinoma in situ of the cervix or prostate cancer in situ) in the last 5 years.
• Hemoglobinopathy or known chronic anemia.
• Donation of a unit (500 ml) or more of blood, a significant loss of blood equivalent to at least one unit of blood in the last 2 weeks, or a blood transfusion in the last 8 weeks.
• Any medical condition / concurrent disorder that at the Investigator´s discretion is likely to: Interfere with the patient´s ability to complete the entire period of the study or participate in all aspects of the study (including but not limited to the ability to perform glucose self-monitoring) blood (SMBG)). Require during the study the administration of a treatment that would affect the interpretation of efficacy and safety data.
• Contraindications and warnings in accordance with the information on the specific country label for sulfonylurea, metformin (if administered as a background treatment) and pioglitazone that are not mentioned in the other exclusion criteria.
• Known hypersensitivity to sulfonylurea, metformin (if administered as a background treatment) or pioglitazone or any of its components.
• Treatment with any antidiabetic medication (other than metformin and sulfonylurea) and / or herbal / non-prescription preparations that may affect glycemic control within a period of 12 weeks before Selection.
• Treatment with exenatide or exendin analogues, or GLP-1 analogs at any time in the past.
• Chronic oral or parenteral treatment with corticosteroids (> 7 consecutive days of treatment) in a period of 4 weeks before Selection.
• Treatment with weight-reducing medications (eg orlistat sibutramine, phentermine) in a period of 12 weeks before selection.
• Registered blood pressure values above systolic blood pressure> 170 mmHg and / or diastolic blood pressure> 105 mmHg in a period of 12 weeks before selection.
• Treatment with antihypertensive medications without a stable dose at least 4 weeks before t
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Change in laboratory HbA1c test values during the study.<br>Measure:Absolute change from baseline in HbA1c<br>Timepoints:24 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Change in laboratory HbA1c test values during the study.<br>Measure:Proportion of patients achieving target HbA1c <=6.5%, <=7%<br>Timepoints:weeks 24, 52 and 104<br>;<br>Outcome name:Measurement of body weight and waist and hip circumference during the study.<br>Measure:Absolute/percentage change from baseline in body weight; responder rate for body weight; absolute/percentage change from baseline in waist and hip circumference;<br>Timepoints:weeks 24, 52 and 104<br>;<br>Outcome name:Fasting plasma glucose value measurement during the study.<br>Measure:absolute/percentage change from baseline in fasting plasma glucose<br>Timepoints:weeks 24, 52 and 104<br>