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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: insulin glulisine (Drug); insulin glargine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Karen Barch, B.S., Study Director, Affiliation: Sanofi

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Compare change in weight from baseline to study week 52 in the per-protocol population of premeal Apidra vs postmeal Apidra, in patients receiving Lantus as basal insulin

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Sanofi-aventis, Bridgewater, New Jersey 08807, United States

Starting date: August 2004
Last updated: January 10, 2011