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Bridgewater, New Jersey 08807


Purpose:

The purpose of this study is to compare the change in weight from baseline to study week 52 in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.


Criteria:

Inclusion Criteria: - Diagnosis of type 2 diabetes mellitus for at least six months - 18 to 70 years of age, inclusive - A1c ≥ 7.5% and ≤ 10% - At least 3 months of continuous insulin and/or insulin analogue therapy (on at least 2 injections per day) +/- metformin prior to study entry - Negative glutamic acid decarboxylase (GAD) autoantibodies - Ability and willingness to perform self-monitoring of blood glucose (SMBG) at least four times a day, and at least 7 times daily during the 7-point blood glucose (BG) profile measurement days - Ability and willingness to adhere to, and be compliant with, the study protocol - Must be able to read English or Spanish at the sixth grade level in order to complete the patient-reported outcomes component of the study - Signed informed consent Exclusion Criteria: - Subjects treated with sulfonylureas, thiazolidinediones (TZDs), or any other oral antidiabetic drugs (at study entry) except for insulin and/or insulin analogues with or without metformin - Planned pregnancy; or pregnant or lactating females - For subjects treated with metformin: serum creatinine ≥ 1.5 mg/dL (133 µmol/L) for males or ≥ 1.4 mg/dL (124 µmol/L) for females - Serum creatinine ≥ 3.0 mg/dL (266 µmol/L) - Any clinically significant renal disease (other than proteinuria) or hepatic disease - Serum ALT or AST levels greater than 2.5 X the upper limit of normal - Any current malignancy or any cancer within the past 5 years (except for adequately treated basal cell skin cancer or cervical carcinoma in situ) - Diagnosis of dementia or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study - Diagnosis of impaired dexterity or vision rendering the subject unable to administer multiple daily injections (MDIs) - Cardiac status New York Heart Association (NYHA) III-IV - Hypersensitivity to Lantus or Apidra or any of their components - Any disease or condition (including abuse of illicit drugs, prescription medicines or alcohol) that, in the opinion of the investigator or sponsor, may interfere with the completion of the study. - Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study - Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol


NCT ID:

NCT00135096


Primary Contact:

Study Director
Karen Barch, B.S.
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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