A multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled study to assess the efficacy, safety and tolerability of taspoglutide (RO5073031) compared to sitagliptin and placebo in patients with type 2 diabetesmellitus inadequately controlled with metformin. - EMERGE 4

• Conditions: Type 2 diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2008-001854-42-SE
• Lead Sponsor: F.Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-23
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 630

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. Treatment with metformin at a stable dose of > 1500 mg/day for at least 12 weeks
prior to screening.
3. HbA1c = 7.0 and = 10.0 % at screening.
4. Body mass index (BMI) > 25 (>23 for Asians) and <45 kg/m2 inclusive at screening.
5. Stable weight ± 5% for at least 12 weeks prior to screening.
6. Agreement to maintain prior diet and exercise habits during the full course of study.
7. 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 or history of:
• Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary
forms of diabetes, e.g., acromegaly or 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. Clinically symptomatic gastrointestinal (GI) disease, including, but not limited to,
inflammatory bowel disease, celiac disease, diabetic gastroparesis.
5. History of gastric bypass or antrectomy or small bowel resection.
6. History of chronic pancreatitis or idiopathic acute pancreatitis.
7. Myocardial infarction (MI), coronary artery bypass surgery, post-transplantation
cardiomyopathy (PTCM) or stroke within the past 6 months.
8. Any abnormality in clinical laboratory tests or ECG, which precludes safe
involvement in the study as judged by the Investigator.
9. Clinically relevant QTc prolongation (e.g. QTc > 480 ms), family history of Long
QT Syndrome, or concomitant use of class I antiarrhythmic drugs (e.g. disopyramide,
quinidine, procainamide, mexiletine, flecainide, propafenone).
10. 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.
11. Known hemoglobinopathy or chronic anemia.
12. Donation of one unit (500 ml) or more of blood, significant blood loss equalling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
13. 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.
14. Contraindications and warnings according to the country-specific label information
for metformin and sitagliptin not listed in the other exclusion criteria.
15. Known hypersensitivity to sitagliptin or any of its components.
16. Treatment with any oral anti-diabetic (other than metformin), and/or herbal/over the counter preparations that may affect glycemic control within 12 weeks prior to
screening.
17. Treatment with exenatide or exendin analogues, GLP-1 or GLP-1 analogues at any time during the past.
18. Treatment with insulin (except during pregnancy) for more than one week within
6 months prior to screening.
19. Chronic oral or parenteral corticosteroid treatment (>7 consecutive days of
treatment) within 4 weeks prior to screening.
20. Treatment with weight lowering agents (e.g. orlistat, sibutramine, rimonabant,
phentermine) during the last 12 weeks prior to screening.
21. History of unstable hypertension (SBP >170 mmHg and/or DBP >105 mmHg)
within the past 12 weeks prior to screening.
22. Treatment with anti-hypertensive medications which are not on a stable dose for at least 4 weeks prior to baseline.
23. Treatment with lipid lowering medications which are not on a stable dose for at least 8 weeks prior to screening.
24. Treatment with thyroid hormones which are not on a stable dose for at least
12 weeks prior to screening.
25. Use of investigational drugs within 30 days or 5 half-lives (whichever is longer)
prior to screening, unless local health authority

Study & Design

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