None listed
Conditions
Interventions
Group 1 Type of group
10 mg of taspoglutide administered once a week (QW)
Group name:Group 3 Type of group
Placebo QW for 24 weeks
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Men and women 18-80 years of age in the selection. Potentially fertile women who use two medically approved methods of birth control (eg, hormonal contraceptives, IUDs, barrier contraceptives) should be willing to use the same contraceptive methods throughout the course of the study. • Patients diagnosed with type 2 diabetes not controlled by diet and exercise. Patients without previous contact with a drug (which is defined as no treatment with an oral antidiabetic agent for at least 12 weeks before screening and without treatment with oral antidiabetic agents for more than 3 consecutive months at any time in the past ). • Negative test for anti-GAD antibodies. • Peptide C (fasting)> 1.0 ng / ml. • HbA1c:> 6.5 and 25 (> 23 for Asians) and <45 kg / m2 in the selection. • Stable weight ± 5% for a minimum of 12 weeks before selection. • Agreement to maintain the previous habits of diet and exercises throughout the course of the study. • Ability and willingness to provide written informed consent and meet the requirements of the study.
Exclusion criteria
Exclusion criteria: • Women who are pregnant, who intend to become pregnant during the study, or who are currently breastfeeding. • Diagnosis or history of: Diabetes mellitus type 1, diabetes as a result of a pancreatic injury, or secondary forms of diabetes, for example, acromegaly and Cushing´s syndrome; Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the last 6 months. • Evidence of clinically significant diabetic complications. • Symptomatic diabetes poorly controlled. • Clinically symptomatic gastrointestinal (GI) disease that includes, without limitation, 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, posttransplant cardiomyopathy (PTCM) or cerebrovascular accident within the last 6 months. • Any abnormality in the clinical laboratory tests or ECHO that prevents the safe participation in the study according to the opinion of the Investigator. • Clinically relevant QTc prolongation (eg, QTc> 480 ms), family history of Long QT Syndrome, or concomitant use of Class I antiarrhythmic drugs (eg, disopyramide, quinidine, procainamide, mexiletine, flecainide, propafenone). • Malignant disease diagnosed and / or treated (with the exception of basal cell cancer, carcinoma of the cervix 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, appears to interfere with the patient´s ability to complete the entire study period or participate in all aspects of the trial, requiring, during the study, the administration of a treatment that would affect the interpretation of the efficacy and safety information. • Treatment with any oral antidiabetic drug and / or herbal / over-the-counter preparations that may affect glycemic control within 12 weeks prior to selection. • Treatment with exenatide or exendin analogs, GLP-1 or GLP-1 analogues, at any time in the past. • Treatment with insulin (except during pregnancy) for more than a week during the 6 months prior to the selection. • Treatment with chronic oral or parenteral 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 antihypertensive drugs that are not in a stable dose for a minimum of 4 weeks before the baseline. • Treatment with lipid-lowering drugs that are not in a stable dose for a minimum of 8 weeks before screening. • Treatment with thyroid hormones that are not in a stable dose for a minimum of 12 weeks before screening. • Use of the investigational drug within 30 days or 5 half-lives (whichever is longer) before selection unless the guidelines of the local health authority require a longer period. • Any of the following laboratory 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 (one week after the last injection). 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
Peru, Slovakia
Contacts
Public ContactCarlos Alberto Battilana
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed