Type 2 diabetes mellitus MedDRA version: 8.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Product Name: GLP-1
Product Code: RO5073031 10% (w/w) sustained release formulation
Pharmaceutical Form: Powder for injection*
CAS Number: 275371-94-3
Current Sponsor code: RO5073031
Other descript
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Type 2 diabetes mellitus patients treated with individual maximum tolerated daily dose of metformin monotherapy (metformin daily dose = 1.5 g, maximum not higher than recommended in the label) for at least 3 months prior to screening. -Males, postmenopausal women (defined as more than two years after the cessation of menses) or surgically sterilized women. -Age 18 to 75 years at the time of the screening examination. -HbA1c = 7.0 % and = 9.5 % at screening. -Fasting plasma glucose (FPG) > 126 mg/dL (7.0 mmol/L) and = 240 mg/dL (13.3 mmol/L) at screening. -BMI > 25 kg/m2 and = 45 kg/m2 at screening -Stable weight ± 10% for at least 3 months before screening. -Patients able and willing to give written informed consent and to comply with the requirements of the study (patients that cannot follow blood glucose selfmonitoring and study requirements independently from another person cannot be included). 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
Exclusion criteria: -Type 1 diabetes mellitus patients -Known hypersensitivity to RO5073031 or any of its components. -Known contraindications to metformin, i.e. -Congestive heart failure requiring pharmacologic treatment; -Clinically significant respiratory insufficiency. -History of ketoacidosis or lactic acidosis. -Treatment with any anti-hyperglycemic medication other than metformin monotherapy during the last 3 months (except insulin use in acute situations or during surgery for up to 7 days). -Any previous exposure to GLP-1, GLP-1 analogues or exenatide before the study. -Systemic use of corticosteroids in the last 3 months. -Use of weight lowering medications (orlistat, sibutramine, rimonabant, phentermine) in the last 3 months. -Patients receiving ACE inhibitors, beta-blockers, thiazide diuretics, thyroid hormones, and/or lipid lowering medications who are not on a stable dose for more than 6 weeks prior to the start of the study. -Impaired liver function (ALAT or ASAT or total bilirubin or alkaline phosphatase > 2.5x ULN) at screening. -Renal disease or renal dysfunction (as suggested by serum creatinine levels = 1.5 mg/dL [males], = 1.4 mg/dl [females]) at screening. -Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg, despite treatment) at the time of the screening examination. -Myocardial infarction or stroke within 6 months prior to the screening examination. -Known hemoglobinopathy. -Known proliferative diabetic retinopathy. -Clinically significant GI disease including inflammatory bowel disease, irritable bowel syndrome, celiac disease, dyspepsia, apparent diabetic gastroparesis, diabetic diarrhoea, or surgery of the gastro-intestinal tract (except appendectomy / cholecystectomy). -Any abnormality in clinical laboratory tests or ECG, which precludes safe involvement in the study as judged by the investigator. -Pregnant or lactating women or women of childbearing potential. -Participation in an investigational drug study within 90 days [3 months] (or treatment with any investigational agent within five half-lives of that investigational drug, whichever is longer) prior to screening. -Serious illness, such as active cancer, major active infection, severe psychiatric disorders at the time of the screening examination. -Alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy, with respect to glycemic control, of multiple doses and regimens of RO5073031 which, when added to metformin, are safe and tolerable compared with placebo in patients with type 2 diabetes.;Secondary Objective: -To compare the effects of RO5073031 with placebo, when both are added to metformin, on body weight and additional parameters of glycemic and lipid control; -To investigate, by a population analysis approach, the pharmacokinetics and the exposure-response relationship of RO5073031 in the target population, including the influence of covariates.;Primary end point(s): EFFICACY / PHARMACODYNAMIC: Absolute change from baseline in HbA1c at the end of the treatment period. | — |
Countries
Bulgaria, Germany, Latvia, Lithuania
Outcome results
None listed