Type 2 Diabetes Mellitus MedDRA version: 14.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Code: AMG 151
Pharmaceutical Form: Film-coated tablet
CAS Number: 1138669-65-4
Current Sponsor code: AMG 151
Concentration unit:
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18 to 75 years, inclusive - Diagnosis of type 2 diabetes mellitus - HbA1c levels = 7.5% to = 11.0% at screening - Fasting C-peptide levels = 0.2 nmol/L at screening - BMI = 25 to = 45 kg/m2 at screening - Treated with metformin monotherapy for at least 3 months prior to randomization; the metformin dose must be = 850 mg daily for at least 2 months immediately prior to randomization - If a subject is being treated for hyperlipidemia or hypertension they should be on stable medication for 30 days before randomization - Subject has provided informed consent - Female subjects must be of non-reproductive potential (ie. postmenopausal by history - no menses for = 1 year and by FSH [using local reference ranges]; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy) 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 175 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Disease Specific - History of type 1 diabetes - History of significant weight gain or loss (>10%) during the 4 weeks before randomization - Use of any weight loss medication (over the counter or prescription) within 60 days of randomization - Use of any oral or injectable anti-hyperglycemic medication (other than metformin) within 3 months prior to randomization - Use of chronic and/or continuous insulin administration for > 15 days in an outpatient setting to achieve and maintain glycemic control prior to randomization - Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months - Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or currently diagnosed as having hypoglycemia unawareness Other Medical Conditions - Evidence of active infections that can interfere with the study - Presence of clinically significant organ system disease that is not stabilized or may interfere with the study - Currently receiving immunosuppressive therapy - History of positive HIV, chronic hepatitis B or C, or cirrhosis - Have symptomatic congestive heart failure or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure or stroke in the past 6 months prior to screening. - History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption - Any finding on the screening ECG that in the opinion of the investigator requires further cardiovascular evaluation - Poorly controlled hypertension defined as diastolic pressure = 100 mm Hg or systolic pressure = 160 mm Hg (assessed on 2 separate occasions during the screening period) - Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred > 5 years ago, subject is eligible with documentation of disease-free state since treatment) Excluded Medications - Use of known inhibitors or inducers of CYP3A4 are not permitted 30 days prior to randomization Laboratory Abnormalities - Triglycerides = 500 mg/dL (5.64 mmol/L) at screening - Hepatic liver enzymes (Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), alkaline phosphatase, total bilirubin) levels > 2 times the upper limit of normal at screening - Hemoglobin < 11 g/dL for men and < 10 g/dL for women - Creatinine Clearance < 60 mL/min as calculated via the MDRD equation (Modification of Diet in Renal Disease study group) as required for metformin use - Any laboratory abnormality, which, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results General - Male subject with a pregnant partner who is not willing to use a condom or practice ab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the dose-effect relationship of AMG 151 compared to placebo, on fasting plasma glucose in subjects with type 2 diabetes treated with metformin; Secondary Objective: To assess the effect of AMG 151 on postprandial glucose levels in response to a meal tolerance test To evaluate the safety and tolerability of AMG 151 ;Primary end point(s): Change in fasting plasma glucose levels from baseline to Day 28;Timepoint(s) of evaluation of this end point: D28 relative to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in area under the curve 0-4 hours (AUC0-4hr) glucose after a meal tolerance test from baseline to Day 28 Change in incremental AUC0-4hr glucose after a meal tolerance test from baseline to day 28 ;Timepoint(s) of evaluation of this end point: D28 relative to baseline | — |
Countries
Czech Republic, Denmark, Estonia, Poland, United States
Contacts
Public ContactIHQ Medical-Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed