Pacientes con diabetes mellitus tipo 2 Patients with Type 2 diabetes MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus MedDRA version: 9 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes)
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 18 - 75 years at screening. Women of childbearing potential using an approved birth control method (e.g. hormonal contraceptives, IUD, barrier contraception) must be willing to use the same methods of contraception during the entire course of the study. 2. Type 2 diabetes patients treated with stable sulfonylurea monotherapy or metformin plus sulfonylurea combination therapy for at least 12 weeks prior to Screening. Sulfonylurea (SU) needs to be at least half-maximally efficacious dose. Metformin dose should be ?1500 mg/day (or individual maximally tolerated dose), but no more than the maximum dose specified in the label. 3. Agreement to reduce the SU dosage at randomization (baseline) to the lowest available dose. 4. HbA1c: ? 7.0% and ? 10% at Screening. 5. Body mass index (BMI) > 25 (> 23 for Asians) and ? 45 kg/m2 at Screening. 6. Stable weight ± 5% for at least 12 weeks prior to Screening. 7. Agreement to maintain prior diet and exercise habits throughout the entire study. 8. Ability and willingness to give written informed consent and to comply with the requirements of the study. 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
Exclusion criteria: 1. Women who are pregnant, intending to become pregnant during the study period or currently lactating 2. Diagnosis of or history of: ? Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g. acromegaly and Cushing?s syndrome; ? Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months. 3. Evidence of clinically significant diabetic complications, e.g. known proliferative retinopathy 4. Clinically symptomatic gastrointestinal (GI) disease including but not limited to inflammatory bowel disease, celiac disease, diabetic gastroparesis, and cholelithiasis 5. History of bariatric surgery (e.g. gastric bypass or antrectomy) or small or large bowel resection 6. History of chronic pancreatitis or idiopathic acute pancreatitis 7. Record of more than 3 episodes of severe hypoglycemia (defined as requiring assistance by another person) within 6 months before Screening 8. Any abnormality in clinical laboratory tests or ECG, which precludes safe involvement in the study as judged by the Investigator 9. Clinically relevant QTc prolongation (e.g. QTc > 480 ms), family history of Long QT Syndrome, or concomitant use of Class I Antiarrythmic drugs (e.g. disopyramide, quinidine, procainamide, mexiletine, flecainide, propafenone) 10. Diagnosed and/or treated malignancy (except basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years 11. Known hemoglobinopathy or chronic anemia 12. Donation of one unit (500 ml) or more blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks 13. Any concurrent medical condition/disorder that, in the opinion of the Investigator is likely to: ? Interfere with the patient?s ability to complete the entire study period or to participate in all aspects of the trial (including and not restricted to the ability to perform the SMBG) ? Require, during the study, the administration of a treatment that would affect the interpretation of the efficacy and safety data 14. Contraindications and warnings according to the country specific label information for sulfonylurea, metformin (if administered as background therapy) and pioglitazone, not listed in the other exclusion criteria 15. Known hypersensitivity to sulfonylurea, metformin (if administered as background therapy) or pioglitazone or any of their components 16. Treatment with any oral anti-diabetic medication (other than metformin and sulfonylurea), and/or herbal/over-the-counter preparations that may affect glycemic control within 12 weeks prior to Screening 17. Treatment with exenatide or exendin analogues, or GLP-1 analogues at anytime during the past 18. Chronic oral or parenteral corticosteroid treatment (>7 consecutive days of treatment) within 4 weeks prior to Screening 19. Treatment with weight lowering agents (e.g. orlistat, sibutramine, phentermine) within 12 weeks prior to Screening 20. Documented values of blood pressure above SBP > 170 mmHg and/or DBP > 105 mmHg within 12 weeks prior to Screening 21. Treatment with anti-hypertensive medications which are not on a stable dose for at least 4 weeks prior to Baseline 22. Treatment with lipid lowering medications which are not on a stable dose for at least 8 weeks prior to Screening 23. Treatment with thyroid hormones which are not on a stable dose for at least 12 weeks prior to Screening 24. Use of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) compared to pioglitazone after 24 weeks of treatment in 648 patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea (SU) monotherapy or metformin plus sulfonylurea combination therapy;Secondary Objective: ? To assess the effects of taspoglutide versus pioglitazone on additional parameters of glycemic control including fasting plasma glucose, the proportion of patients target HbA1c levels of <7.0% and <6.5%, the proportion of patients requiring rescue medication and time-toglycemic rescue ? To assess the effects of taspoglutide versus pioglitazone on body weight loss parameters including change in body weight, percentage of patients who achieve a body weight loss of at least 5% or 10%, and waist and hip circumferences ? To assess the safety (including rates hypoglycemic events) and tolerability of taspoglutide versus pioglitazone up to 52 weeks treatment ? To describe the pharmacokinetics of taspoglutide and to estimate between-patient variability using a population PK approach, exploring and quantifying the potential influence of covariates that contribute significantly to the between-patient differences in PK parameters of taspoglutide;Primary end point(s): The primary endpoint of the study is the absolute change from baseline in HbA1c (%) after 24 weeks. | — |
Countries
France, Germany, Poland, Slovakia, Spain, United Kingdom
Outcome results
None listed