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

NCT00353691 | Completed Phase 3

• 1 other identifier: HOE490_4038
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

• 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)

Interventions

glimepiride DRUG

metformin DRUG

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

Related Publications (1)

• 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. doi: 10.2337/dc06-1554.

  PMID: 17392540 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepiride; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Karen Barch, B.S.

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 17, 2006
• First Posted: July 19, 2006
• Study Start: October 1, 2002
• Study Completion: November 1, 2004
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

US (1)