Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bridgewater, New Jersey 08807


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.


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



Primary Contact:

Study Director
Karen Barch, B.S.

Backup Contact:


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: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.