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

NCT ID: NCT00135096

Last Updated: 2011-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 345 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2007-07-31

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: EXPERIMENTAL

insulin glulisine

Intervention Type: DRUG

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.

2

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.

Group Type: EXPERIMENTAL

insulin glargine

Intervention Type: DRUG

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.

Interventions

insulin glulisine

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.

Intervention Type: DRUG

insulin glargine

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Karen Barch, B.S.

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-aventis

Bridgewater, New Jersey, United States

Countries

United States

References

Ratner R, Wynne A, Nakhle S, Brusco O, Vlajnic A, Rendell M. Influence of preprandial vs. postprandial insulin glulisine on weight and glycaemic control in patients initiating basal-bolus regimen for type 2 diabetes: a multicenter, randomized, parallel, open-label study (NCT00135096). Diabetes Obes Metab. 2011 Dec;13(12):1142-8. doi: 10.1111/j.1463-1326.2011.01478.x.

Reference Type: DERIVED

PMID: 21812890 (View on PubMed)

Other Identifiers

HMR1964A_3503

Identifier Type: -

Identifier Source: org_study_id