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

Type 2 Diabetes Mellitus Clinical Trial

— LEGEND  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699932
• Other study ID #: GLMET_R_05823
• Secondary ID: U1111-1120-0058
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2012
• Last updated: May 7, 2014
• Start date: September 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

-To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of HbA1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus.

Secondary Objective:

To assess the effects of the fixed combination of glimepiride and metformin at week 24 on:

• Percentage of patients reaching HbA1c <7%

• Percentage of patients reaching HbA1c <6.5%.

• Fasting Plasma Glucose (FPG)

• Safety and tolerability

Description:

The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period and 3 days follow-up period with a last call phone visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Glimepiride+metformin (Amaryl M®) - HOE4900
Pharmaceutical form:tablet Route of administration: oral

Locations

Country	Name	City	State
Lebanon	Investigational Site Number 422-002	Beirut
Lebanon	Investigational Site Number 422-001	Hazmieh
Russian Federation	Investigational Site Number 643001	Samara
Russian Federation	Investigational Site Number 643002	St-Petersburg
Russian Federation	Investigational Site Number 643-03	St.-Petersburg
Ukraine	Investigational Site Number 804003	Chernivtsi
Ukraine	Investigational Site Number 804001	Donetsk
Ukraine	Investigational Site Number 804004	Donetsk
Ukraine	Investigational Site Number 804008	Donetsk
Ukraine	Investigational Site Number 804010	Odessa
Ukraine	Investigational Site Number 804006	Poltava
Ukraine	Investigational Site Number 804002	Vinnytsya
Ukraine	Investigational Site Number 804007	Vinnytsya

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Lebanon,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		from baseline to week 24	No
Secondary	Percentage of patients with HbA1c < 7%		at week 24	No
Secondary	Percentage of patients with HbA1c < 6.5%		at week 24	No
Secondary	Change in Fasting Plasma Glucose (FPG)		from baseline to week 24	No
Secondary	Number of patients with adverse events		over the 24-week treatment period	Yes
Secondary	Hypoglycemia		over the 24-week treatment period	Yes