Glimepiride vs Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00353691

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: glimepiride Drug: metformin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Glimepiride Versus Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus: A Single Blind Comparison Study

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Glimepiride

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change in HbA1c from baseline to Week 24 or last evaluable ontreatment value.

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

Estimated Enrollment:	100
Study Start Date:	October 2002
Estimated Study Completion Date:	November 2004

Eligibility

Ages Eligible for Study:	8 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

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%).
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.
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:

A history of an acute metabolic complication such as diabetic ketoacidosis within 3 months before screening
On insulin therapy, or had received insulin for >6 weeks, 3 months prior to randomization
On weight-reduction medication
Known hypersensitivity to biguanides, sulfonamides, or insulin
Pregnant or lactating females
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])
GI disorders that may interfere with the absorption of the study drugs
Chronic use of medications known to affect glucose levels such as intermittent use of systemic corticosteroids or large dose of inhaled steroids
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
History of drug or alcohol abuse
Treatment with any investigational product in the last 3 months before study entry
History of noncompliance with regard to follow-up medical care
Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353691

Locations

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

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Karen Barch, B.S.

Sanofi-Aventis

More Information

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00353691 History of Changes
Other Study ID Numbers:	HOE490_4038
Study First Received:	July 17, 2006
Last Updated:	January 10, 2011
Health Authority:	United States: Food and Drug Administration

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
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2012