A multi-center, randomized, open-label, active-controlled study to compare the efficacy, safety and tolerability of taspoglutide (RO5073031) versus insulin glargine in insulin-naive type 2 diabetic patients inadequately controlled with metformin and sulphonylurea combination therapy. - EMERGE 5

Not Applicable

• Conditions: -E11 Non-insulin-dependent diabetes mellitus; Non-insulin-dependent diabetes mellitus; E11

• Registration Number: PER-140-08
• Lead Sponsor: PRODUCTOS ROCHE Q.F.S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

• Men and women 18 - 75 years of age at the time of screening. Potentially fertile women who use two medically approved birth control methods (for example, hormonal contraceptives, IUDs, barrier contraceptives) should be willing to use the same contraceptive methods throughout the course of the study.
• Patients with type 2 diabetes treated with a stable dose of metformin and sulfonylurea (including the fixed combination of immediate or prolonged release) for a minimum of 12 weeks before screening. The dose of metformin should be> 1500 mg / day (or the maximum dose tolerated individually) but not greater than the maximum dose specified in the insert; Sulfonylurea can be administered at any dose.
• Agreement that sulfonylurea treatment should be discontinued 5 days (+/- 1 day) before the start of the treatment period (Day 1).
• HbA1c:> 7.0% and <10% in screening.
• Body mass index (BMI)> 25 (> 23 for Asians) and <45 kg / m2 in screening.
• Stable weight ± 5% for a minimum of 12 weeks before screening.
• Fasting serum C peptide> 1 ng / ml.
• 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

• Women who are pregnant, who intend to become pregnant during the study period, or who are currently breastfeeding.
• Diagnosis or history of: Type I diabetes, diabetes as a result of pancreatic injury, or secondary forms of diabetes, for example, acromegaly and Cushing´s syndrome; Acute metabolic diabetic complications, such as ketoacidosis or hyperosmolar coma within the last 6 months.
• Evidence of clinically significant diabetic complications.
• Diabetic proliferative retinopathy diagnosed.
• Clinically symptomatic gastrointestinal (GI) disease that includes, without limitation, 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.
• More than 3 episodes of severe hypoglycemia (defined as another person´s request for help) within 6 months before screening.
• History of inadvertent hypoglycemia.
• Myocardial infarction (MI), coronary artery bypass surgery, post-transplant cardiomyopathy (PTCM) or stroke within 6 months before screening.
• Any abnormality in clinical laboratory tests or ECG that prevents safe participation in the study according to the opinion of the Researcher.
• 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).
• Diagnosed and / or treated malignant disease (with the exception of basal cell skin cancer, cervical carcinoma in situ, 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, significant loss of blood 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 Researcher, seems to: interfere with the patient´s ability to complete the entire period of the study or participate in all aspects of the test; require, during the study, the administration of a treatment that would affect the interpretation of the efficacy and safety data.
• Contraindications and warnings according to the information of the country-specific insert for metformin and insulin glargine that do not appear in the other exclusion criteria.
• Known hypersensitivity to metformin or insulin glargine or any of its components.
• Treatment with any oral antidiabetic drug (other than metformin and sulfonylureas) and / or herbal preparations / without a prescription that may affect glycemic control within 12 weeks prior to screening.
• Treatment with exenatide or exendin analogues, GLP-1 or GLP-1 analogs, at any time in the past.
• Insulin treatment (except during pregnancy) for more than one week, within 6 months prior to screening.
• Treatment with chronic oral or parenteral corticosteroids (> 7 consecutive days of treatment) within 4 weeks prior to screening.
• Treatment with weight reducing agents (for example, orlistat, sibutramine, rimonabant, phentermine) during the last 12 weeks prior to screening.
• History of unstable hypertension (SBP> 170 mmHg and / or DBP> 105 mmHg) within the last 12 weeks prior to screening.
• Treatment with antihypertensive drugs that are not in a stable dose for a mini

Study & Design

• Study Type: Interventional
• Study Design: Not specified