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

NCT00135096 | Completed Phase 3

• 1 other identifier: HMR1964A_3503
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  52 weeks

Study Arms (2)

1

EXPERIMENTAL

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.

Drug: insulin glulisine

2

EXPERIMENTAL

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.

Drug: insulin glargine

Interventions

insulin glulisine 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.

1

insulin glargine 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.

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes mellitus for at least six months
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-aventis

Bridgewater, New Jersey, 08807, United States

Location

Related Publications (1)

• 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.

  PMID: 21812890 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin glulisine; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Karen Barch, B.S.

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 23, 2005
• First Posted: August 25, 2005
• Study Start: August 1, 2004
• Study Completion: July 1, 2007
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

US (1)