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

NCT ID: NCT00353691

Last Updated: 2011-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2004-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

glimepiride

Intervention Type: DRUG

metformin

Intervention Type: DRUG

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Principal Investigators

Karen Barch, B.S.

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Bridgewater, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 17392540 (View on PubMed)

Other Identifiers

HOE490_4038

Identifier Type: -

Identifier Source: org_study_id