Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin)
NCT ID: NCT00708578
Last Updated: 2011-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
99 participants
INTERVENTIONAL
2008-05-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Insulin Glargine in Type 2 Diabetic Patients
NCT00347100
Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus
NCT00290927
Insulin Glargine Combination Therapies in Type II Diabetics
NCT00783744
Efficacy and Safety of Insulin Glargine in Patients With Type 2 Diabetes With Inadequate Control on DPP-4 Inhibitor Therapy
NCT02027753
Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy
NCT03359837
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Administration of 4 mg of Glimepiride with Insulin Glargine
Glimepiride
Once a day before breakfast
Insulin Glargine
Injection in the morning
2
Administration of 1500 mg of Metformin with Insulin Glargine
Metformin
After breakfast and supper
Insulin Glargine
Injection in the morning
3
Administration of a combination of 4mg Glimepiride plus 1000mg Metformin with Insulin Glargine
Glimepiride
Once a day before breakfast
Metformin
After breakfast and supper
Insulin Glargine
Injection in the morning
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Glimepiride
Once a day before breakfast
Metformin
After breakfast and supper
Insulin Glargine
Injection in the morning
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sanofi-aventis
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ji Young Ahn
Role: STUDY_DIRECTOR
Sanofi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sanofi-Aventis Administrative Office
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LANTU_L_02670
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.