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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Glimepiride+metformin (Amaryl M®) - HOE4900

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Phase 3

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Investigational Site Number 422-002
  • Hazmieh, Lebanon
    • Investigational Site Number 422-001
• Russian Federation
  • Samara, Russian Federation
    • Investigational Site Number 643001
  • St-Petersburg, Russian Federation
    • Investigational Site Number 643002
  • St.-Petersburg, Russian Federation
    • Investigational Site Number 643-03
• Ukraine
  • Chernivtsi, Ukraine, 58022
    • Investigational Site Number 804003
  • Donetsk, Ukraine, 83003
    • Investigational Site Number 804008
  • Donetsk, Ukraine, 83059
    • Investigational Site Number 804004
  • Donetsk, Ukraine, 83099
    • Investigational Site Number 804001
  • Odessa, Ukraine
    • Investigational Site Number 804010
  • Poltava, Ukraine, 36011
    • Investigational Site Number 804006
  • Vinnytsya, Ukraine, 21010
    • Investigational Site Number 804007
  • Vinnytsya, Ukraine, 21029
    • Investigational Site Number 804002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Arm 1; 24-week treatment period: starting dose will be of 2/1000 mg or 4/2000 mg of glimepiride/metformin fixed combination (Amaryl M® ) depending on the previous treatment and dose. The Interventional medicinal product's dose will be increased every 2 weeks up to the maximum tolerated dose of 8/2000 mg of Amaryl M® , and adjusted throughout the 24-week treatment period according to fasting Self Monitored Plasma Glucose (SMPG) values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and > 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c	from baseline to week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with HbA1c < 7%	at week 24
Percentage of patients with HbA1c < 6.5%	at week 24
Change in Fasting Plasma Glucose (FPG)	from baseline to week 24
Number of patients with adverse events	over the 24-week treatment period
Hypoglycemia	over the 24-week treatment period

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: September 26, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimate): October 4, 2012

Study Record Updates

• Last Update Posted (Estimate): May 8, 2014
• Last Update Submitted That Met QC Criteria: May 7, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors; Metformin; Glimepiride
• Other Study ID Numbers: GLMET_R_05823; U1111-1120-0058 (Other Identifier: UTN)