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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionType 2 Diabetes Mellitus
InterventionDrug: glimepiride
Drug: metformin
PhasePhase 3
SponsorSanofi
Responsible PartySanofi
ClinicalTrials.gov IdentifierNCT00353691
First ReceivedJuly 17, 2006
Last UpdatedJanuary 10, 2011
Last verifiedJanuary 2011

Tracking Information[ + expand ][ + ]

First Received DateJuly 17, 2006
Last Updated DateJanuary 10, 2011
Start DateOctober 2002
Estimated Primary Completion DateNovember 2004
Current Primary Outcome MeasuresChange in HbA1c from baseline to Week 24 or last evaluable ontreatment value.
Current Secondary Outcome Measures
  • 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

Descriptive Information[ + expand ][ + ]

Brief TitleGlimepiride vs Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus
Official TitleGlimepiride 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: glimepiride
Drug: metformin
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment100
Estimated Completion DateNovember 2004
Estimated Primary Completion DateNot Provided
Eligibility 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
GenderBoth
Ages8 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00353691
Other Study ID NumbersHOE490_4038
Has Data Monitoring CommitteeNot Provided
Information Provided BySanofi
Study SponsorSanofi
CollaboratorsNot Provided
Investigators Study Director: Karen Barch, B.S. Sanofi
Verification DateJanuary 2011

Locations[ + expand ][ + ]

Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807