Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Type 2 diabetes
age 30-80 years
body mass index < 43 kg/m2
HbA1c ≤ 10% for at least 12 weeks prior to screening
stable diabetes therapeutic regimen consisting of either diet, oral hypoglycemic agents (no more than 2), or insulin (with or without no more than 1 oral hypoglycemic agent) for 4 weeks prior to randomization

Exclusion Criteria:

Subject who had taken prescription sympathomimetic drugs within seven (7) days prior to the first screening visit. Prescription sympathomimetic drugs were not allowed for any period greater than ten (10) consecutive days during the course of the study. Other ergot alkaloid derivatives or anti-migraine medications such as zolmitriptan (Zomig) and sumatriptan (Imitrex) were not permitted during the study.
Subject who had a history of alcoholism or drug abuse in the three (3) years prior to the first screening visit.
Subject who had a known hypersensitivity to any of the formulation components of the study drug.
Subject who had received any experimental drug or used an experimental device in the 30 days prior to the first screening visit or would do so during the study.
Subject who was pregnant or lactating women or women planning to become pregnant during the study. Women of childbearing potential had to have a negative pregnancy test at screening. Women who became pregnant were discontinued from the study.
Subject who had given donations of blood during the 30 days prior to the screening visit. Donation of blood also was prohibited during the study and for 30 days after completion of the study.

Subjects with clinically significant major organ system disease, such as

seizure disorder
significant gastroparesis or orthostatic hypotension (autonomic neuropathy)
cerebrovascular accident in the previous 6 months
uncontrolled hypertension (systolic BP >160 or diastolic BP > 100 at screening)
coronary artery bypass graft or coronary angioplasty in the previous 3 months, myocardial infarction in the previous 6 months, or unstable angina pectoris (chest pain at rest, worsening chest pain, or admission to the ER or hospital for chest pain) within the previous 3 months
congestive heart failure defined by NYHA as Class III or IV
clinical nephrotic syndrome, or renal impairment with a serum creatinine > 1.4 mg/dl if female receiving treatment with metformin, > 1.5 mg/dl if male receiving treatment with metformin, and > 1.6 mg/dl in not on metformin
impaired liver function, including having AST or ALT greater than three times the upper limit of normal
active infection (e.g., HIV, hepatitis), or a history of severe infection during the 30 days prior to screening
major surgical operation during the 30 days prior to screening
cancer, other than non-melanoma skin or non metastatic prostate cancer within the past 5 years
Any concurrent illness, other than diabetes mellitus, not controlled by a stable therapeutic regimen
Working rotating, varying or night shifts
Patients taking unapproved herbal supplements that may be associated with a risk of cardiovascular events (such as ephedra, yohimbe etc)
Patients who had started therapy with an erectile dysfunction drug within 2 weeks prior to screening; patients could not begin treatment with an erectile dysfunction drug during the study period; patients previously taking erectile dysfunction drugs could do so only under medical supervision.
Subjects with circumstances or abnormalities (e.g., blindness or a history of non-compliance) that would interfere with the interpretation of safety or efficacy data or completion of the study.
Clinically significant abnormalities (values outside the normal range) on screening central laboratory evaluation unless discussed with and approved by the study principal investigator or Sponsor medical monitor.