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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc; Metformin

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