COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Insulin Glulisine in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00135057
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : January 11, 2011
Information provided by:

Brief Summary:
The purpose of this study is to compare the change in glycemic control, as measured by hemoglobin A1c (HbA1c) from baseline to study week 24, in subjects receiving insulin glulisine as mealtime insulin following a variable bolus insulin regimen (based on carbohydrate counting) versus a fixed bolus insulin regimen, with insulin glargine as basal insulin in both arms of the study.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: insulin glulisine Drug: insulin glargine Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Insulin Glulisine Administered in a Fixed Bolus Regimen Versus Variable Bolus Regimen Based on Carbohydrate Counting in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin
Study Start Date : April 2004
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Compare the change in glycemic control (as measured by A1c) from baseline to endpoint of fixed dose bolus regimen vs. variable bolus regimen based on carbohydrate count

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of type 2 diabetes mellitus for at least six months; 18 to 70 years of age, inclusive.
  • A1c ≥ 7.0% and ≤ 10% at screening
  • At least 3 months of continuous insulin and/or insulin analogue therapy (on at least 2 injections) +/- metformin prior to study entry. (Note: Subjects receiving insulin glargine [Lantus] twice a day [split dose] will be considered as being on one injection only.)
  • Willingness of subject to discontinue other anti-diabetic drug treatments and to remain off them through the entire study
  • 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 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 (within the 3 months before 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) 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 insulin glulisine (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00135057

Layout table for location information
United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Layout table for investigator information
Study Director: Karen Barch, B.S. Sanofi
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Study Director, sanofi-aventis Identifier: NCT00135057    
Other Study ID Numbers: HMR1964A_3502
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Glargine
Insulin glulisine
Hypoglycemic Agents
Physiological Effects of Drugs