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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00553020
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study Completion: 2005-07
• Status Verified: 2007-10
• Study First Submitted: 2007-10-31
• Study First Submitted QC: 2007-10-31
• Last Update Submitted: 2007-10-31
• Study First Posted: 2007-11-02
• Last Update Posted: 2007-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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	during the study conduct

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of insulin glargine (LantusT) and NPH-insulin (ProtaphanT) on suppression of endogenous glucose production, endogenous insulin secretion, and lipolysis	during the study conduct