Insulin Glulisine Administered in a Fixed Bolus Regimen Versus Variable Bolus Regimen Based on Carbohydrate Counting in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin

Sanofi1 site in 1 country281 target enrollmentApril 2004

ConditionsDiabetes Mellitus, Type 2

Drugsinsulin glulisine insulin glargine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
Sponsor: Sanofi
Enrollment: 281
Locations: 1
Primary Endpoint: Compare the change in glycemic control (as measured by A1c) from baseline to endpoint of fixed dose bolus regimen vs. variable bolus regimen based on carbohydrate count
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the change in glycemic control, as measured by hemoglobin A1c (HbA1c) from baseline to study week 24, in subjects receiving insulin glulisine as mealtime insulin following a variable bolus insulin regimen (based on carbohydrate counting) versus a fixed bolus insulin regimen, with insulin glargine as basal insulin in both arms of the study.

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

August 2005

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Eligibility Criteria

Inclusion Criteria

•Diagnosis of type 2 diabetes mellitus for at least six months; 18 to 70 years of age, inclusive.
•A1c ≥ 7.0% and ≤ 10% at screening
•At least 3 months of continuous insulin and/or insulin analogue therapy (on at least 2 injections) +/- metformin prior to study entry. (Note: Subjects receiving insulin glargine \[Lantus\] twice a day \[split dose\] will be considered as being on one injection only.)
•Willingness of subject to discontinue other anti-diabetic drug treatments and to remain off them through the entire study
•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 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 (within the 3 months before 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) 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

Outcomes

Primary Outcomes

Compare the change in glycemic control (as measured by A1c) from baseline to endpoint of fixed dose bolus regimen vs. variable bolus regimen based on carbohydrate count