Insulin Glulisine in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin

Sanofi

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: insulin glulisine

Drug: insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00135057

HMR1964A_3502

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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
Hypersensitivity to Lantus or insulin glulisine (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.