A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of taspoglutide (RO5073031) compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy - EMERGE 7
- Conditions
- Patients with Type 2 diabetesMedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus
- Registration Number
- EUCTR2008-005809-20-GB
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 357
1. Men and women, aged 18 - 75 years at screening. Women of childbearing potential will use one medically approved method of contraception during the course of the trial.
2. Patients with type 2 diabetes mellitus on metformin at a stable dose of = 1500 mg/day (or individually maximally tolerated dose) for at least 12 weeks prior to screening.
3. HbA1c: = 6.5 and = 9.5% at screening.
4. Body mass index (BMI) = 30 and = 50 kg/m2 at screening.
5. Stable weight ± 5% for at least 12 weeks prior to screening.
6. Agreement to follow a diet and exercise plan during the course of the 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
1. Women who are pregnant, intending to become pregnant during the study period or currently lactating females.
2. Diagnosis of or history of: a. Type 1 diabetes mellitus, diabetes resulting from
pancreatic injury, or secondary forms of diabetes, e.g., acromegaly and Cushing’s Syndrome. b. 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, cholelithiasis.
5. History of bariatric surgery (e.g. gastric bypass or antrectomy) or small or large 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 for 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 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 not listed in the other exclusion criteria.
15. Known hypersensitivity to metformin or any of its components.
16. Treatment with any oral anti-diabetic medication and/or herbal/over the counter preparations, other than metformin, 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 anytime during the past.
18. Treatment with insulin (except during pregnancy) for more than one week within 6 months prior to screening.
19. Treatment with systemic (oral or parenteral) corticosteroids for more than 7 consecutive days within 12 weeks prior to screening
20. Treatment with weight lowering agents (e.g. orlistat, sibutramine, rimonabant, phentermine) and/or herbal/over the counter preparations for obesity within 12 weeks prior to screening.
21. Documented values of blood pressure above 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 or anti-thyroid drugs which are not at a stable dose for at least 12 weeks prior to screening.
25. Use
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: - To assess the effects of taspoglutide versus placebo on body weight.<br>- To assess the effects of taspoglutide versus placebo on additional parameters of diabetes control and CV risk factors including lipid profile.<br>- To assess the safety and tolerability of taspoglutide versus placebo.<br>- To describe the pharmacokinetics of taspoglutide and to estimate between-patient variability using a population PK approach.;Main Objective: To assess the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy compared to placebo after 24 weeks of treatment.;Primary end point(s): The primary endpoint of the study is the absolute change from baseline in HbA1c (%)<br>after 24 weeks.
- Secondary Outcome Measures
Name Time Method