Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Due to technical issues relating to the Electronic diary data.)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00283049
First received: January 26, 2006
Last updated: January 7, 2011
Last verified: January 2011

January 26, 2006
January 7, 2011
February 2006
November 2008   (final data collection date for primary outcome measure)
Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12 [ Time Frame: 12 weeks from Baseline ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00283049 on ClinicalTrials.gov Archive Site
  • Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage [ Time Frame: 60 weeks from Baseline ] [ Designated as safety issue: No ]
  • Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5% [ Time Frame: 60 weeks from Baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia [ Time Frame: 60 weeks from Baseline ] [ Designated as safety issue: Yes ]
    • 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 ] [ Designated as safety issue: Yes ]
    • 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.
Not Provided
Not Provided
Not Provided
 
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
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

The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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%)
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
390
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00283049
HOE901_4052
Not Provided
Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Lisa Jean-Louis Sanofi
Sanofi
January 2011

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