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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: insulin glargine; Drug: insulin glulisine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00135096

HMR1964A_3503

Details and patient eligibility

About

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.

Enrollment: 345 patients

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 ≥ 7.5% 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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345 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Drug: insulin glulisine

2

Experimental group

Description:

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.

Treatment:

Drug: insulin glargine