Assessment of Duration of Metabolic Effect of a Single Bolus of sc Injected Lantus Compared to NPH Insulin in Patients With Type 2 Diabetes

Sanofi

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00553020

HOE901_4050

Details and patient eligibility

About

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

Enrollment

16 patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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