Inclusion Criteria
Female or male patients with T1DM for at least 1 year, diagnostic criteria as defined by the
American Diabetes Association; and receiving daily insulin
Female patients must meet one of the following criteria:
a. Participant is of childbearing potential and agrees to use one of the accepted contraceptive
regimens throughout the entire duration of the trial from screening until last follow-up visit. An acceptable method of contraception includes at least one of the following:
i. Abstinence from heterosexual intercourse
ii. Systemic contraceptives (birth control pills, injectable/implant/ insertable hormonal birth
control products, transdermal patch); if the participant is using systemic contraceptives,
he must use an additional form of acceptable contraception (iii or iv, below)
iii. Intrauterine device (with and without hormones)
iv. Condom with spermicide
or
b. Participant is of non-childbearing potential due to pre-puberty status or a medical condition
confirmed by the investigator
Male patients must meet the following criteria: If sexually active, uses condom and partner
practices contraception during the trial from screening and until last follow-up visit
* Informed consent signatures must be obtained according to local regulations.
Exclusion Criteria
Females who are pregnant according to a positive urine pregnancy test, actively attempting to get
pregnant, or are lactating
Known or suspected allergy to trial product(s) or related products
History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema)
Previous randomization in this trial
History of an episode of severe hypoglycemia that required a third party assistance within a
month prior to screening visit
History of hypoglycemic events associated with seizures or hypoglycemia unawareness in the last
year prior to screening
History of epilepsy or seizure disorder
Receipt of any investigational drug within 3 months prior to screening
Active malignancy within the last 5 years
Congestive heart failure, New York Heart Association class II-IV
Current bleeding disorder, including anti-coagulant treatment
Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e.
insulin secreting pancreas tumor)
Use of a daily systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the
previous 28 days before Day 1 of this trial
Clinically significant abnormal electrocardiogram (ECG) at screening as judged by the investigator
Clinically significant illness within 4 weeks before screening as judged by the investigator
Surgery or trauma with significant blood loss within the last 2 months prior to screening
Patients with mental incapacity or language barriers which preclude adequate understanding or
cooperation, who are unwilling to participate in the trial, or who in the opinion of the investigator should not participate in the trial
Any condition interfering with trial participation or evaluation or that could be hazardous to the patient
The use of prescription or non-prescription medications known to cause QT prolongation