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

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 IV

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Insulin glargine Metformin Metformin hydrochloride Insulin glulisine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

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

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
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 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: 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 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

Responsible Party:	sanofi-aventis ( Study Director )
Study ID Numbers:	HMR1964A/3503
First Received:	August 23, 2005
Last Updated:	January 7, 2008
ClinicalTrials.gov Identifier:	NCT00135096
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Insulin glulisine

Metabolic Diseases

Metformin

Diabetes Mellitus, Type 2

Glargine

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008

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