Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGinsulin glulisine
PREMEAL ARM: Subjects randomized to this arm will receive Apidra administered three times per day 0-15 min before the three main meals; metformin (if applicable); and Lantus qd for 52 weeks.
DRUGinsulin glargine
POSTMEAL ARM: Subjects randomized to this arm will receive Apidra administered three times per day immediately after a meal (20 min after the start of a meal); metformin (if applicable); and Lantus qd for 52 weeks.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare change in weight from baseline to study week 52 in the per-protocol population of premeal Apidra vs postmeal Apidra, in patients receiving Lantus as basal insulin | 52 weeks |
Countries
United States
Outcome results
None listed