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Glimepiride vs Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus

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.
 
ClinicalTrials.gov Identifier: NCT00353691
Recruitment Status : Completed
First Posted : July 19, 2006
Last Update Posted : January 11, 2011
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE July 17, 2006
First Posted Date  ICMJE July 19, 2006
Last Update Posted Date January 11, 2011
Study Start Date  ICMJE October 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2006)
Change in HbA1c from baseline to Week 24 or last evaluable ontreatment value.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2006)
  • Change in HbA1c from baseline to Week 12
  • Responder rate, defined as proportion of subjects with HbA1c < 7.0% at Week 24 or last evaluable on-therapy observation
  • Mean change in fasting SMBG from baseline to each visit at weeks 4, 8, 12, 18 and 24 or last evaluable on-treatment value.
  • Mean change in fasting plasma glucose (FPG) from baseline to each visit at weeks 4, 8, 12, 18 and 24 or last evaluable on-treatment value.
  • Percent completers, defined as subjects who continued study medication until completion of all requirements of Visit 6 (Week 18)
  • Mean change in lipid levels (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides) from baseline to Wk 24 or last evaluable on-treatment value.
  • Mean change in body mass index (BMI) from baseline to Wk 12 and Wk 24 or last evaluable on-treatment value
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glimepiride vs Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus
Official Title  ICMJE Glimepiride Versus Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus: A Single Blind Comparison Study
Brief Summary To compare the change in glycemic control from baseline to endpoint (last available posttreatment assessment) as measured by HbA1c in pediatric subjects with type 2 diabetes receiving either glimepiride or metformin as monotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: glimepiride
  • Drug: metformin
Study Arms  ICMJE Not Provided
Publications * Gottschalk M, Danne T, Vlajnic A, Cara JF. Glimepiride versus metformin as monotherapy in pediatric patients with type 2 diabetes: a randomized, single-blind comparative study. Diabetes Care. 2007 Apr;30(4):790-4.

*   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 Completed
Enrollment  ICMJE
 (submitted: July 17, 2006)
100
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

INCLUSION CRITERIA:

  1. Subjects who had type 2 diabetes treated with diet and exercise only for at least 2 weeks prior to randomization, or who were previously or currently treated with an oral agent and had not responded to diet, exercise, and oral therapy for at least 3 months (documented by an HbA1c >7.5%).
  2. Subjects who completed glimepiride pharmacokinetic Study HOE 490/4045 at preselected sites within 3 weeks prior to the screening period were also permitted to enroll.
  3. Subjects were required to be negative for islet cell antigen (ICA) and glutamic acid decarboxylase (GAD) autoantibodies and to have a C-peptide level at 90 minutes of ≥ 1.5 ng/mL. The HbA1c was required to be >7.1% at screening and <12.0% on the day of randomization.

EXCLUSION CRITERIA:

Subjects meeting any of the following criteria were not to be included in the study:

  1. A history of an acute metabolic complication such as diabetic ketoacidosis within 3 months before screening
  2. On insulin therapy, or had received insulin for >6 weeks, 3 months prior to randomization
  3. On weight-reduction medication
  4. Known hypersensitivity to biguanides, sulfonamides, or insulin
  5. Pregnant or lactating females
  6. Clinically significant renal (serum creatinine level >1.0 mg/dL) or hepatic disease (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >2.5 times the upper limits of normal [ULN])
  7. GI disorders that may interfere with the absorption of the study drugs
  8. Chronic use of medications known to affect glucose levels such as intermittent use of systemic corticosteroids or large dose of inhaled steroids
  9. Clinically significant laboratory abnormality on screening laboratory tests or any medical condition that in the opinion of the investigator would affect the outcome of the study
  10. History of drug or alcohol abuse
  11. Treatment with any investigational product in the last 3 months before study entry
  12. History of noncompliance with regard to follow-up medical care
  13. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
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 NCT00353691
Other Study ID Numbers  ICMJE HOE490_4038
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Karen Barch, B.S. 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