None listed
Conditions
Interventions
Group 1 Type of group
Taspoglutide 10 mg once a week (QW) for 24 weeks.
Group name:Group 3 Type of group
Exenatide 5 mcg twice a day (BID) for 4 weeks and
then 10 mcg BID for 24 weeks.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Men and women between 18-75 years of age at the time of selection. Potentially fertile women who use two medically approved methods of birth control (eg, hormonal contraceptives, IUDs, barrier methods) should be willing to use the same contraceptive methods throughout the course of the study. • Patients with type 2 diabetes mellitus who receive> 1500 mg / day of metformin and / or> 30 mg / day of pioglitazone or> 4 mg / day of rosiglitazone (in countries where the combination of thiazolidinediones and exenatide is approved) or the maximum dose specified on the label of the compounds mentioned above. These doses must be stable for at least 12 weeks before selection. • HbA1c> 7.0% and 25 (> 23 for Asian patients) and <45 kg / m ^ at the time of selection. • Stable weight ± 5% for at least 12 weeks prior to selection. • Patients must agree to maintain the previous habits of diet and exercise during the entire course of the study. • The patient must show that he can and wants to provide written informed consent and meet the requirements of the study.
Exclusion criteria
Exclusion criteria: • Women who are pregnant, plan to become pregnant during the study period or currently breastfeed. • Diagnosis or history of; to. Type 1 diabetes, diabetes caused by pancreatic injury or secondary forms of diabetes, for example, acromegaly and Cushing´s syndrome. b. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the last 6 months. • Evidence of clinically significant diabetic complications. • Clinically symptomatic gastrointestinal (GI) disease including inflammatory bowel disease, celiac disease, diabetic gastroparesis. • History of gastric bypass or antrectomy or small bowel resection. • History of chronic pancreatitis or acute idiopathic pancreatitis. • Myocardial infarction (MI), coronary artery bypass surgery, post-transplant cardiomyopathy (PTCM) or cerebrovascular accident within the last 6 months. • Any abnormality in the clinical laboratory tests or the ECHO that may prevent a safe participation in the study, according to the investigator´s criteria. • Clinically relevant QTc prolongation (eg, QTc> 480 ms), family history of Long QT Syndrome or concomitant use of Class 1 Antiarrhythmic drugs (eg, disopyramide, quinidine, procainamide, mexiletine, flecainide, propafenone). • Diagnosis and / or malignancy treated (with the exception of basal cell skin cancer, carcinoma of the neck in situ, or prostate cancer in situ) within the last 5 years. • Known hemoglobinopathy or chronic anemia. • Donation of one unit (500 ml) or more of blood, significant blood loss equivalent to at least one unit of blood within the last 2 weeks or a blood transfusion within the last 8 weeks. • Any concurrent medical condition / disorder that, in the opinion of the investigator, is likely to: Interfere with the patient´s ability to participate in all aspects of the test. Require, during the study, the administration of a treatment that could affect the interpretation of efficacy and safety data. • Contraindications and warnings according to the label information of metformin, pioglitazone, rosiglitazone and exenatide specific to the country that is not shown in the other exclusion criteria. • Known hypersensitivity to pioglitazone, rosiglitazone or metformin, or to any of its components. • Known hypersensitivity to exenatide or to exendin analogues. • Treatment with any oral dialytic medication (other than metformin, thiazolidinediones) and / or herbal / over-the-counter preparations that may affect glycemic control within 12 weeks prior to selection. • Treatment with exenatide or analogs of exendin, GLP-1 or GLP-1 analogs at any time in the past. • Treatment with insulin (except during pregnancy) for more than a week within 6 months prior to selection. • Chronic oral or parenteral treatment with corticosteroids (> 7 consecutive days of treatment) within 4 weeks prior to selection. • Treatment with weight-reducing agents (eg, orlistat, sibutramine, rimonabant, phentermine) during the last 12 weeks prior to selection. • History of unstable hypertension (SBP> 170 mmHg and / or DBP> 105 mmHg) within the last 12 weeks prior to selection. • Treatment with doses of antihypertensive agents that are not stable for at least 4 weeks before Basal. • Treatment with doses of lipid-lowering medications that are not stable for at least 8 weeks prior to selection. • Treatment with doses of thyroid hormones that are not stable for a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:An analysis of variance will be used to evaluate the possible differences in the absolute change in HbA1c (%) between the different treatment groups. Measure:Absolute change from baseline in HbA1c (%) after 24 weeks of treatment Timepoints:24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as the percentage of patients achieving an HbA1c level equal to or less than 6.5% and equal to or less than 7% at the end of the treatment period Measure:HbA1c response rates Timepoints:24 weeks ; Outcome name:Measurement of fasting plasma glucose values by laboratory tests during the study. Measure:Absolute and percentage change with respect to baseline in Fasting Plasma Glucose (mg / dL or mmol / L) Timepoints:24 weeks ; Outcome name:For weight measurement, the patient should be dressed in house clothes, without shoes and should have an empty bladder. Participants should be weighed on the same scale in all visits. Measure:Absolute and percentage change with respect to the baseline in body weight (in kg) Timepoints:24 weeks ; Outcome name:Measurement of fasting proinsulin values by laboratory tests during the study. Measure:Absolute and percentage change with respect to baseline in fasting proinsulin (pmol / L), fasting proinsulin / insulin ratio, and HOMA-B Timepoints:24 weeks ; Outcome name:Measurement of post-prandial glucose values (hr * mg / dL), insulin (hr-pIU / mL), C-peptide (hr * pmol / L) and glucagon (hr-pmol / L) by laboratory tests during the study . Measure:Percentage change in AUC of post-prandial glucose values (hr * mg / dL), insulin (hr-pIU / mL), C peptide (hr * pmol / L) and glucagon (hr-pmol / L) after of a food tolerance test (7 time points over 3 hours, in a subgroup of patients). Timepoints:24 weeks | — |
Countries
Denmark, Finland, Gabon, Germany, Greece, Italy, Spain, Sweden
Contacts
Public ContactCarlos Alberto Battilana
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed