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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708578
• Other study ID #: LANTU_L_02670
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2008
• Last updated: January 24, 2011
• Start date: May 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Kangbuk Samsung Medical Center
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Glimepiride
Once a day before breakfast
• Metformin
After breakfast and supper
• Insulin Glargine
Injection in the morning

Locations

Country	Name	City	State
Korea, Republic of	Sanofi-Aventis Administrative Office	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c values		At baseline to end of treatment	No
Secondary	Hypoglycemia events		From inclusion to end of study	Yes
Secondary	Percentage of patients with HbA1c < 7%		At the end of the study	No
Secondary	Fasting Blood Glucose level		At the end of the study	No