To assess the duration of the metabolic effect of a sc injected single dose of either
insulin glargine (LantusT) or NPH-insulin (ProtaphanT) on blood glucose control in patients
with type 2 diabetes
Inclusion Criteria:
- Type 2 diabetes mellitus of either gender as defined by the American Diabetes
Association (3) for more than 6 months
- BMI (as defined in Appendix A of the protocol) between 28 kg/mý and 32 kg/mý (before
implementation of Amendment 1) or between 26 kg/mý and 34 kg/mý (after implementation
of Amendment 1)
- Having required treatment with insulin for at least 6 months
- Stable glycemic control with glycohemoglobin (HbA1c) >7. 5% and <9. 5% (before
implementation of Amendment 1) or >7. 0% and <9. 5% (after implementation of Amendment
1
- Fasting serum C-peptide >0. 2 pmol/mL. According to Amendment 3, five additional
subjects with "low" (defined as less than or equal to 0. 4 pmol/mL) and 5 subjects
with "high" (defined as >0. 4 pmol/mL) fasting C-peptide were to be enrolled.
- Negative pregnancy test in female subjects of childbearing potential (only for those
who were not surgically sterile or who were less than 2 years postmenopausal) at the
beginning of the study
- No findings in medical history and physical examination (cardiovascular system, chest
and lungs, thyroid, abdomen, nervous system, skin and mucosae, and muscular-skeletal
system) which were clinically relevant and interfering with the conduct of the study
- Normal ECG, blood pressure, pulse rate and core body temperature unless the
investigator considered an abnormality to be clinically irrelevant and not
interfering with the conduct of the study
Exclusion Criteria:
- Subjects with "brittle" diabetes or predisposition to severe hypoglycemia, e. g. 2 or
more severe hypoglycemic episodes (i. e. requiring assistance of another person)
within the past year, or any hospitalization or emergency room visit due to poor
diabetic control within the past 6 months
- Subjects who had been treated with insulin with a total insulin dose of >1. 5
IU/kg/day
- Pregnant and nursing women
- Female subjects of childbearing potential (those who are not surgically sterile or
who are less than 2 years postmenopausal) unwilling or unable to use reliable
contraceptive measures. Reliable contraceptive measures included the following:
systemic contraceptive (oral, implant, injection), diaphragm with intravaginal
spermicide, cervical cap, intrauterine device, or condom with spermicide.
- Any condition requiring the regular use of any medication if the regular use of this
medication interfered with the study conduct
- Abuse of alcoholic beverages (as defined in Appendix B of the protocol)
- Treatment with oral antidiabetic drugs within the last 4 weeks
- Treatment in the previous 3 months with any drug known to have a well-defined
potential for toxicity concerning vital organs
- Symptoms of any major internal medical disease in the 4 weeks before the study which,
according to the investigator's opinion, could interfere with the purposes of the
study
- History of hypersensitivity to any drugs that have a similar chemical structure to
the study drug
- History or presence of gastrointestinal, liver, or kidney disease or other conditions
known to interfere with the absorption, distribution, metabolism, or excretion of
drugs
- Blood donation during the previous 3 months
- Positive HIV- or hepatitis B/C-test
- Progressive fatal disease
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
