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

Overview[ - collapse ][ - ]

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
ConditionType 2 Diabetes Mellitus
InterventionDrug: Glimepiride
Drug: Metformin
Drug: Insulin Glargine
PhasePhase 4
SponsorSanofi
Responsible PartySanofi
ClinicalTrials.gov IdentifierNCT00708578
First ReceivedJune 27, 2008
Last UpdatedJanuary 24, 2011
Last verifiedJanuary 2011

Tracking Information[ + expand ][ + ]

First Received DateJune 27, 2008
Last Updated DateJanuary 24, 2011
Start DateMay 2008
Estimated Primary Completion DateDecember 2009
Current Primary Outcome MeasuresHbA1c values [Time Frame: At baseline to end of treatment] [Designated as safety issue: No]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitleOptimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin)
Official TitleInsulin Glargine Combined With Sulfonylurea Versus Metformin in Patients With Type 2 Diabetes: A Randomized, Controlled Trial.
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
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: Glimepiride
Once a day before breakfast
Drug: Metformin
After breakfast and supper
Drug: Insulin Glargine
Injection in the morning
Study Arm (s)
  • Active Comparator: 1
    Administration of 4 mg of Glimepiride with Insulin Glargine
  • Active Comparator: 2
    Administration of 1500 mg of Metformin with Insulin Glargine
  • Experimental: 3
    Administration of a combination of 4mg Glimepiride plus 1000mg Metformin with Insulin Glargine

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment99
Estimated Completion DateDecember 2009
Estimated Primary Completion DateDecember 2009
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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesKorea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number NCT00708578
Other Study ID NumbersLANTU_L_02670
Has Data Monitoring CommitteeNo
Information Provided BySanofi
Study SponsorSanofi
CollaboratorsNot Provided
Investigators Study Director: Ji Young Ahn Sanofi
Verification DateJanuary 2011

Locations[ + expand ][ + ]

Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of