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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00135096

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: insulin glulisine Drug: insulin glargine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Insulin beef Insulin glargine Insulin glulisine

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 [ Time Frame: 52 weeks ]

Enrollment:	345
Study Start Date:	August 2004
Study Completion Date:	July 2007

Arms	Assigned Interventions
Experimental: 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.	Drug: 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.
Experimental: 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.	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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135096

Locations

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

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Karen Barch, B.S.

Sanofi-Aventis

More Information

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00135096 History of Changes
Other Study ID Numbers:	HMR1964A_3503
Study First Received:	August 23, 2005
Last Updated:	January 10, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine

Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012