Clinical trial NCT00135096: Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin
Official title: APIDRA® (Insulin Glulisine) Administered Premeal vs Postmeal in Adult Subjects With Type 2 Diabetes Mellitus Receiving LANTUS® (Insulin Glargine) as Basal Insulin: a Multicenter, Randomized, Parallel, Open Label Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-08-25
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-aventis
state: New Jersey
Study officials:
affiliation: Sanofi
name: Karen Barch, B.S.
role: STUDY_DIRECTOR
References:
citation: Ratner R, Wynne A, Nakhle S, Brusco O, Vlajnic A, Rendell M. Influence of preprandial vs. postprandial insulin glulisine on weight and glycaemic control in patients initiating basal-bolus regimen for type 2 diabetes: a multicenter, randomized, parallel, open-label study (NCT00135096). Diabetes Obes Metab. 2011 Dec;13(12):1142-8. doi: 10.1111/j.1463-1326.2011.01478.x.