Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01699932
• Date of registration: 26/09/2012
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled LEGEND
• Scientific title: A Multinational, Open Label, Non Comparative, 24-week Study to Evaluate the Blood Glucose Lowering Efficacy and Safety of a Fixed Dose Combination of Glimepiride and Metformin in Patients With Inadequately Controlled Type 2 Diabetes
• Date of first enrolment: September 2012
• Target sample size: 167
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01699932
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Lebanon, Russian Federation, Ukraine

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria:

- Patients with type 2 diabetes mellitus inadequately controlled despite a treatment
with sulfonylurea (SU) alone or metformin alone or a free combination of SU and
metformin prior to the study entry.

- Signed informed consent, obtained prior any study procedure

Exclusion criteria:

- Age < legal age of adulthood

- HbA1c < 7% or = 11%

- BMI > 35 kg/m2

- Treatment with a stable dose of maximally tolerated SU alone or metformin alone or
the free combination of SU and metformin for less than 12 weeks prior to the
screening visit.

- Patients who received any anti-diabetic drug other than SU or metformin within 12
weeks prior to the screening visit.

- Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to
pancreatic disorders, drug or chemical agent intake…)

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Glimepiride+metformin (Amaryl M®) - HOE4900

Primary Outcome(s)

Change in HbA1c [Time Frame: from baseline to week 24]

Secondary Outcome(s)

Change in Fasting Plasma Glucose (FPG) [Time Frame: from baseline to week 24]

Number of patients with adverse events [Time Frame: over the 24-week treatment period]

Percentage of patients with HbA1c < 7% [Time Frame: at week 24]

Hypoglycemia [Time Frame: over the 24-week treatment period]

Percentage of patients with HbA1c < 6.5% [Time Frame: at week 24]

Secondary ID(s)

GLMET_R_05823

U1111-1120-0058

Source(s) of Monetary Support

Please refer to primary and secondary sponsors