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

• Conditions: Type 2 diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2008-001855-23-FI
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 990

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. Type 2 diabetic patients treated with a stable dose of metformin and sulphonylurea (including immediate or extend-release fixed combination) for at least 12 weeks prior to screening. The dose of metformin must be = 1500 mg/day (or individual maximally tolerated dose), but no more than the maximum dose specified in the label; sulphonylurea can be at any dose.
3. Agreement that the sulphonylurea treatment must be stopped 5 days (+/- 1 day) before the start of the treatment period (Day 1).
4. HbA1c: = 7.0% and = 10% at screening.
5. Body mass index (BMI) > 25 (> 23 for Asians) and = 45 kg/m2 at screening.
6. Stable weight ± 5% for at least 12 weeks prior to screening.
7. Fasting serum C-peptide > 1 ng/ml.
8. Agreement to maintain prior diet and exercise habits during the full course of the study.
9. Ability and willingness to give written informed consent and to comply with the requirements of the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Women who are pregnant, intending to become pregnant during the study period or currently lactating females.
2. Diagnosis of or history of:
• Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g. acromegaly and 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. Diagnosed proliferative diabetic retinopathy.
5. Clinically symptomatic gastrointestinal (GI) disease including -but not limited to- inflammatory bowel disease, celiac disease, diabetic gastroparesis.
6. History of gastric bypass or antrectomy, or small bowel resection.
7. History of chronic pancreatitis or idiopathic acute pancreatitis.
8. More than 3 episodes of severe hypoglycemia (defined as requiring assistance by another person) within 6 months prior to screening.
9. History of hypoglycemia unawareness.
10. Myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within 6 months prior to screening.
11. Any abnormality in clinical laboratory tests or ECG, which precludes safe involvement in the study as judged by the Investigator.
12. Clinically relevant QTc prolongation (e.g. QTc > 480 ms), family history of Long QT Syndrome, or concomitant use of Class I anti-arrhythmic drugs (e.g. disopyramide, quinidine, procainamide, mexiletine, flecainide, propafenone).
13. 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.
14. Known hemoglobinopathy or chronic anemia.
15. Donation of one unit (500 ml) or more blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
16. 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.
17. Contraindications and warnings according to the country specific label information for metformin and insulin glargine not listed in the other exclusion criteria.
18. Known hypersensitivity to metformin or insulin glargine or any of their components.
19. Treatment with any oral anti-diabetic medication (other than metformin and sulphonylureas), and/or herbal/over-the-counter preparations that may affect glycemic control within 12 weeks prior to screening.
20. Treatment with exenatide or exendin analogues, GLP-1 or GLP-1 analogues at anytime during the past.
21. Treatment with insulin (except during pregnancy) for more than one week, within 6 months prior to screening.
22. Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 4 weeks prior to screening.
23. Treatment with weight lowering agents (e.g. orlistat, sibutramine, rimonabant, phentermine) during the last 12 weeks prior to screening.
24. History of unstable hypertension (SBP > 170 mmHg and/or DBP > 105 mmHg), within the past 12 weeks prior to screening.
25. Treatment with anti-hypertensive medications which are not on a stable dose for at least 4 weeks prior to baseline.
26. Treatment with lipid lowering medications which are not on a stable d

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified