ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: glimepiride Drug: metformin Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Glimepiride Versus Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus: A Single Blind Comparison Study
Study Start Date : October 2002
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Change in HbA1c from baseline to Week 24 or last evaluable ontreatment value.

Secondary Outcome Measures :
  1. Change in HbA1c from baseline to Week 12
  2. Responder rate, defined as proportion of subjects with HbA1c < 7.0% at Week 24 or last evaluable on-therapy observation
  3. Mean change in fasting SMBG from baseline to each visit at weeks 4, 8, 12, 18 and 24 or last evaluable on-treatment value.
  4. 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.
  5. Percent completers, defined as subjects who continued study medication until completion of all requirements of Visit 6 (Week 18)
  6. Mean change in lipid levels (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides) from baseline to Wk 24 or last evaluable on-treatment value.
  7. Mean change in body mass index (BMI) from baseline to Wk 12 and Wk 24 or last evaluable on-treatment value


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.


Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00353691


Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Karen Barch, B.S. Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00353691     History of Changes
Other Study ID Numbers: HOE490_4038
First Posted: July 19, 2006    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors