A multi-center, double-blind, randomized, placebo controlled, dose-ranging phase 2 study to investigate pharmacodynamics, safety, tolerability and pharmacokinetics of RO5073031 in patients with type 2 diabetes mellitus treated with a stable dose of metformin (BC20688)

• Conditions: Type 2 diabetes mellitus; MedDRA version: 8.1Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2006-004407-19-LT
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 264

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

-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.

Study & Design

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