Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00135096
- Lead Sponsor
- Sanofi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 345
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 insulin 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. 2 insulin 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-aventis
🇺🇸Bridgewater, New Jersey, United States