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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00708578

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Glimepiride Drug: Metformin Drug: Insulin Glargine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Insulin Glargine Combined With Sulfonylurea Versus Metformin in Patients With Type 2 Diabetes: A Randomized, Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Insulin Glimepiride Insulin glargine Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

HbA1c values [ Time Frame: At baseline to end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hypoglycemia events [ Time Frame: From inclusion to end of study ] [ Designated as safety issue: Yes ]
Percentage of patients with HbA1c < 7% [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
Fasting Blood Glucose level [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

Enrollment:	99
Study Start Date:	May 2008
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Administration of 4 mg of Glimepiride with Insulin Glargine	Drug: Glimepiride Once a day before breakfast Drug: Insulin Glargine Injection in the morning
2: Active Comparator Administration of 1500 mg of Metformin with Insulin Glargine	Drug: Metformin After breakfast and supper Drug: Insulin Glargine Injection in the morning
3: Experimental Administration of a combination of 4mg Glimepiride plus 1000mg Metformin with Insulin Glargine	Drug: Glimepiride Once a day before breakfast Drug: Metformin After breakfast and supper Drug: Insulin Glargine Injection in the morning

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708578

Locations

Korea, Republic of
Sanofi-aventis Administrative Office
Seoul, Korea, Republic of

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Ji Young Ahn

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LANTU_L_02670
Study First Received:	June 27, 2008
Last Updated:	February 5, 2010
ClinicalTrials.gov Identifier:	NCT00708578 History of Changes
Health Authority:	Korea: Kangbuk Samsung Medical Center

Additional relevant MeSH terms:

Metabolic Diseases
Immunologic Factors
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents
Insulin

Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Glargine
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010