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COMPLETEDPHASE3

Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin

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

NCT00135096•Sanofi

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (1)

Sanofi-aventis

Bridgewater, New Jersey, United States

Key Dates

Start Date

August 1, 2004

Completion Date

July 1, 2007

Last Updated

January 11, 2011

Enrollment

345

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin glulisine

DRUG

insulin glargine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

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