Clinical trial NCT01464437 (phase 2, status: completed)
Conditions: diabetes mellitus
ICD codes: P70.2, O24.92, Z83.3, E10.65, E10.9, E11.65, E11.9
Drugs: amg 151, placebo, metformin, amg 151, amg 151, amg 151, amg 151, amg 151
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CSCC[C@H](N)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 75 years, inclusive

          -  Diagnosis of type 2 diabetes mellitus

          -  HbA1c levels 7.5% to 11.0%, inclusive, 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.

        Exclusion Criteria:

          -  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

          -  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 two 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)

          -  Use of known inhibitors or inducers of CYP3A4 are not permitted 30 days prior to
             randomization