None listed
Conditions
Interventions
Group 1 Type of group
Once daily oral administration of placebo (matching sitagliptin). Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
Group name:Group 4 Type of group
Once weekly sc injection of 10 mg of taspoglutide for the first 4 weeks, then up-titrated to once weekly sc injection of 20 mg of taspoglutide from week 5 onwards. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Men and women 18 to 75 years of age in the selection. Potentially fertile women who use two medically approved contraceptive methods (for example, hormonal contraceptives, IUDs, barrier contraceptives), should be willing to use the same contraceptive methods during the entire course of the study. • Treatment with metformin with a stable dose of> 1500 mg / day for at least 12 weeks before selection. • HbA1c> 7.0 and 25 (> 23 for Asians) and <45 kg / m2 in the selection. • Stable weight ± 5% for at least 12 weeks before selection. • Acceptance of maintaining the previous diet and exercise habits during the total course of the study. • Ability and willingness to give informed written consent and to comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: • Potentially fertile women trying to get pregnant during the study period or currently breastfeeding women. • Diagnosis or history of: Type 1 diabetes mellitus, diabetes resulting from pancreatic damage, or secondary forms of diabetes, for example acromegaly or Cushing´s syndrome, 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, but not limited to, inflammatory bowel disease, celiac disease, diabetic gastroparesis. • History of gastric bypass or antrectomy or resection of the small intestine. • History of chronic pancreatitis or acute idiopathic pancreatitis. • Myocardial infarction (MI), coronary artery bypass surgery, post-transplant cardiomyopathy (PTCM) or stroke within the last 6 months. • Any abnormality in clinical laboratory or ECG tests, which excludes safe participation in the study, according to the investigator´s criteria. • Clinically relevant QTc extension (ie, QTc> 480 ms), family history of Prolonged QT Syndrome, or accompanying use of Class I antiarrhythmic drugs (for example disopyramide, quinidine, procainamide, mexiletine, flecainide, propafenone). • Diagnosed and / or treated malignancy (except basal cell skin cancer, carcinoma in situ of the cervix or prostate cancer in situ) within the last 5 years. • Hemoglobinopathy or known chronic anemia. • Donation of one unit (500 ml) or more of blood, loss of blood equal 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, according to the researcher, probably: Interferes with the patient´s ability to complete the period of the total study or participate in all aspects of the test, require, during the study, the administration of a treatment that It would affect the interpretation of safety and efficacy data. • Contraindications and warnings according to the specific label information in the country for metformin and sitagliptin not included in the other exclusion criteria. • Known hypersensitivity to metformin or sitagliptin or any of its components. • Treatment with an oral anti-diabetic (other than metformin) and / or herbal preparations / without a prescription that may affect glycemic control within 12 weeks prior to selection. • Treatment with exenatide or exendin analogues, GLP-1 or GLP-1 analogs at any time during the past. • Insulin treatment (except during pregnancy) for more than one week within 6 months prior to selection. • Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 4 weeks prior to selection. • Treatment with weight reducing agents (for example, 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 before selection. • Treatment with antihypertensive drugs that are not taken in a stable dose for at least 4 weeks prior to baseline. • Treatment with lipid reducing drugs that are not taken in a stable dose for at least 8 weeks before selection. • Treatment with thyroid hormones that are not taken in a stable dose for at least 12 weeks prior to selection. • Use of investigational drugs within 30
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of laboratory values during the study Measure:Absolute change from baseline in HbA1c (%) after 24 weeks Timepoints:24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of laboratory values during the study Measure:The absolute / percentage change of fasting plasma glucose (FPG) from baseline. Timepoints:24 weeks ; Outcome name:Measurement of body weight during the study. Measure:The absolute / percentage change in body weight compared to baseline. Timepoints:24 weeks ; Outcome name:defined as the percentage of patients who achieve a HbA1c level equal to or less than 6.5% or 7% Measure:Response rates for HbA1c Timepoints:24 weeks ; Outcome name:Defined as the percentage of patients who achieve a loss of body weight of at least 5% or 10% Measure:Response rates for body weight Timepoints:24 weeks ; Outcome name:Measurement of laboratory values during the study Measure:The absolute / percentage changes in the lipid profile with respect to baseline: triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol and LDL / HDL ratio. Timepoints:24 weeks | — |
Countries
Denmark, France, Germany, Greece, Slovakia, Spain, Sweden, United Kindgdom
Contacts
Public ContactAnibal Enrique Salas
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed