Clinical trial NCT00708578: Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin)
Official title: Insulin Glargine Combined With Sulfonylurea Versus Metformin in Patients With Type 2 Diabetes: A Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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.

Primary outcomes:
measure: HbA1c values
timeFrame: At baseline to end of treatment
Secondary outcomes:
measure: Hypoglycemia events
timeFrame: From inclusion to end of study
measure: Percentage of patients with HbA1c < 7%
timeFrame: At the end of the study
measure: Fasting Blood Glucose level
timeFrame: At the end of the study
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Ji Young Ahn
role: STUDY_DIRECTOR
References:
citation: Park CY, Kang JG, Chon S, Noh J, Oh SJ, Lee CB, Park SW. Comparison between the therapeutic effect of metformin, glimepiride and their combination as an add-on treatment to insulin glargine in uncontrolled patients with type 2 diabetes. PLoS One. 2014 Mar 10;9(3):e87799. doi: 10.1371/journal.pone.0087799. eCollection 2014.