Type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Product Name: TASPOGLUTIDE
Product Code: RO5073031/F04-04
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TASPOGLUTIDE
Current Sponsor code: RO5073031
Concentration unit: mg/ml millig
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 two medically approved birth control methods (e.g. hormonal contraceptives, IUD, barrier contraception), must be willing to use the same methods of contraception during the whole course of the study. 2. Treatment with pioglitazone = 30 mg/day and metformin at > 1500 mg/day, or the maximum tolerated dose or the maximum dose specified in the label, for at least 12 weeks, including at least 12 weeks on stable dose prior to screening. 3. HbA1c = 7.0 and = 10.0 % at screening. 4. Body mass index (BMI) > 25 (> 23 for Asians) and =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 females. 2. Diagnosis or history of: • Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g., acromegaly or 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. 4. Clinically symptomatic gastrointestinal (GI) disease, including, but not limited to, inflammatory bowel disease, celiac disease, diabetic gastroparesis. 5. History of gastric bypass or antrectomy or small bowel resection. 6. History of chronic pancreatitis or idiopathic acute pancreatitis. 7. Myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months. 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 antiarrhythmic 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 of blood, significant blood loss equal 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; • To 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 metformin and pioglitazone not listed in the other exclusion criteria. 15. Known hypersensitivity to pioglitazone or metformin or any of their components. 16. Treatment with any oral anti-diabetic medication (other than metformin and pioglitazone), 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, GLP-1 or GLP-1 analogues at any time during the past. 18. Treatment with insulin (except during pregnancy) for more than one week within 6 months prior to screening. 19. Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 4 weeks prior to screening. 20. Treatment with weight lowering agents (e.g. orlistat, sibutramine, rimonabant, phentermine) during the last 12 weeks prior to screening. 21. History of unstable hypertension (SBP > 170 mmHg and/or DBP > 105 mmHg) within the past 12 weeks prior to screening. 22. Treatment with anti-hypertensive medications which are not on a stable dose for at least 4 weeks prior to baseline. 23. Treatment with lipid lowering medications which are not on a stable dose for at least 8 weeks prior to screening. 24. Treatment with thyroid hormones which are not on a stable dose for at least 12 weeks prior to screening. 25. Use of investigational drugs within 30 days or 5 half-lives (whichever is longer) prior
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the efficacy of taspoglutide versus placebo on glycemic control (as assessed by HbA1c) after 24 weeks of treatment, in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone.;Primary end point(s): • Absolute change from baseline in HbA1c. ;Secondary Objective: • Absolute/percentage change from baseline in fasting plasma glucose (FPG). • Absolute/percentage change from baseline in body weight. • Responder rates, defined as target HbA1c: = 7.0%, = 6.5%. • Absolute/percentage change from baseline in lipid profile: triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol and LDL/HDL ratio. • Beta cell function (indexed by fasting pro-insulin concentration, fasting proinsulin/ insulin ratio, HOMA-B). • To assess the safety and tolerability of taspoglutide. • 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. | — |
Countries
France, Germany
Outcome results
None listed