Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin)

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Glimepiride (Drug); Metformin (Drug); Insulin Glargine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Ji Young Ahn, Study Director, Affiliation: Sanofi-Aventis

Overall contact:
Public Registry GMA, Email: publicregistryGMA@sanofi-aventis.com

Primary objective:

To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level

Secondary objective:

To compare the incidence of hypoglycemia in each treatment group

Official title: Insulin Glargine Combined With Sulfonylurea Versus Metformin in Patients With Type 2 Diabetes: A Randomized, Controlled Trial.

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: HbA1c values

Secondary outcome:

Hypoglycemia events

Percentage of patients with HbA1c < 7%

Fasting Blood Glucose level

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 2 diabetes for at least 6 months

- Treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea

(glimepiride≥ 4 mg/day or equivalent dose of other SU) for at least 3 months prior to the screening visit

- 7. 0 < HbA1c < 11 %

- Fasting serum C-peptide > 0. 33 nmol/L

- BMI < 30 kg/m²

- Patients who is willing to monitor BG using SMBG

Exclusion Criteria:

- Type 1 Diabetes

- Clinical evidence of active liver disease, or serum ALT 3 times the upper limit of the

normal range

- Serum creatinine: ≥ 1. 5 mg/dl for males, ≥ 1. 4 mg/dl for females

- Active proliferative diabetic retinopathy, as defined by the application of

photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)

- History of alcohol or other substance abuse

- Pregnancy or not using contraceptive in childbearing aged women

- Breast feeding women

- History of hypersensitivity to the study drugs or to drugs with a similar chemical

structure

- Treatment with any medication including corticosteroid or herbal medicines that can

affect blood glucose level within 3 months prior to study entry except metformin and sulfonylurea.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Public Registry GMA, Email: publicregistryGMA@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Seoul, Korea, Republic of; Recruiting

Starting date: June 2008
Last updated: January 9, 2009