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Insulin Glargine Injection Treatment in Place of Thiazolidinedione (TZD), Sulfonylurea, or Metformin in Triple Agent Therapy for Type 2 Diabetes Mellitus (T2DM) Adult Subjects With Unsatisfactory Control

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ClinicalTrials.gov Identifier: NCT00283049
Recruitment Status : Terminated (Due to technical issues relating to the Electronic diary data.)
First Posted : January 27, 2006
Results First Posted : February 19, 2010
Last Update Posted : January 13, 2011
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE January 26, 2006
First Posted Date  ICMJE January 27, 2006
Results First Submitted Date  ICMJE December 16, 2009
Results First Posted Date  ICMJE February 19, 2010
Last Update Posted Date January 13, 2011
Study Start Date  ICMJE February 2006
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2010)
Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12 [ Time Frame: 12 weeks from Baseline ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00283049 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2011)
  • Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage [ Time Frame: 60 weeks from Baseline ]
  • Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5% [ Time Frame: 60 weeks from Baseline ]
  • Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime) [ Time Frame: 60 weeks from Baseline ]
  • Change From Baseline to End of Study and to Individual Time Points in Components of Lipid Profile (Total Cholesterol, High-density Lipoprotein Cholesterol [HDL], Low-density Lipoprotein Cholesterol [LDL], Triglycerides, LDL Subfractions) [ Time Frame: 60 weeks from Baseline ]
  • Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia [ Time Frame: 60 weeks from Baseline ]
    • Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.
    • Mild-to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL
    • Severe hypoglycemia: assistance of another party is required & either:
      • SMBG of <36 mg/dL, or
      • with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.
    • Serious hypoglycemia:
      • Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion.
  • Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia [ Time Frame: 60 Weeks from Baseline ]
    • Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.
    • Mild-to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL
    • Severe hypoglycemia: assistance of another party is required & either:
      • SMBG of <36 mg/dL, or
      • with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.
    • Serious hypoglycemia:
      • Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Insulin Glargine Injection Treatment in Place of Thiazolidinedione (TZD), Sulfonylurea, or Metformin in Triple Agent Therapy for Type 2 Diabetes Mellitus (T2DM) Adult Subjects With Unsatisfactory Control
Official Title  ICMJE Safety and Efficacy of Insulin Glargine Injection [rDNA Origin] Treatment in Place of the TZD or the Sulfonylurea or Metformin in Triple Agent Therapy for T2DM Adult Subjects With Unsatisfactory Control
Brief Summary The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Insulin Glargine
    Insulin glargine administered subcutaneously once daily.
  • Drug: Insulin Glulisine
    Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Study Arms  ICMJE
  • Experimental: Insulins + Sulfonylurea (SU) + Thiazolidinedione (TZD)
    Arm 1: Insulin glargine administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
    Interventions:
    • Drug: Insulin Glargine
    • Drug: Insulin Glulisine
  • Experimental: Insulins + Metformin (MET) + Thiazolidinedione (TZD)
    Arm 2: Insulin glargine administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
    Interventions:
    • Drug: Insulin Glargine
    • Drug: Insulin Glulisine
  • Experimental: Insulins + Metformin (MET) + Sulfonylurea (SU)
    Arm 3: Insulin glargine administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added arms after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
    Interventions:
    • Drug: Insulin Glargine
    • Drug: Insulin Glulisine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 27, 2010)
390
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects meeting all of the following criteria will be considered for enrollment into the study:

  1. 18 to 79 years of age, inclusive
  2. Diagnosis of type 2 diabetes mellitus
  3. Continuous treatment with therapeutic dosages of a thiazolidinedione (rosiglitazone or pioglitazone), metformin, and a sulfonylurea daily prior to entering the study
  4. Screening HbA1c ≥ 7.0%
  5. Fasting C-peptide concentration ≥ 0.27 ng/ml
  6. Negative glutamic acid decarboxylase (GAD) antibodies
  7. Demonstrated ability and willingness to perform self-monitoring blood glucose (SMBG) using a plasma-referenced glucose meter and to maintain an electronic diary
  8. Demonstrated ability and willingness to use an electronic diary to record SMBG results, insulin doses, and hypoglycemic events.
  9. Signed, informed consent and Health Insurance Portability and Accountability Act (HIPAA) documentation

Exclusion Criteria:

  1. Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months
  2. Cardiac status New York Heart Association (NYHA) III-IV
  3. Impaired renal function as shown by, but not limited to, serum creatinine ≥ 1.5 mg/dL for males, or ≥ 1.4 mg/dL for females
  4. Chronic use of insulin: (more than 3 weeks of continuous use) in the past 12 months
  5. Acute infection
  6. Clinically significant peripheral edema
  7. Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis
  8. Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of the normal range
  9. History of hypoglycemia unawareness
  10. Pregnancy or lactation
  11. Known hypersensitivity to insulin glargine or any of the components of Lantus®
  12. Known hypersensitivity to insulin glulisine or any of the components of Apidra®
  13. Any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ
  14. Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years
  15. Diagnosis of dementia
  16. 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
  17. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences 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
  18. subject is currently taking or was treated with the following medications 3 months prior to screening: Byetta(exenatide), Starlix(nateglinide),Prandin (repaglinide), Januvia(sitagliptin), Janumet(metformin + sitagliptin)
  19. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00283049
Other Study ID Numbers  ICMJE HOE901_4052
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lisa Jean-Louis Sanofi
PRS Account Sanofi
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP