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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Glimepiride+metformin (Amaryl M®) - HOE4900
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 422-002
  • Investigational Site Number 422-001
  • Investigational Site Number 643001
  • Investigational Site Number 643002
  • Investigational Site Number 643-03
  • Investigational Site Number 804003
  • Investigational Site Number 804008
  • Investigational Site Number 804004
  • Investigational Site Number 804001
  • Investigational Site Number 804010
  • Investigational Site Number 804006
  • Investigational Site Number 804007
  • Investigational Site Number 804002

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in HbA1c

Secondary Outcome Measures

Percentage of patients with HbA1c < 7%
Percentage of patients with HbA1c < 6.5%
Change in Fasting Plasma Glucose (FPG)
Number of patients with adverse events
Hypoglycemia

Full Information

First Posted
September 26, 2012
Last Updated
May 7, 2014
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01699932
Brief Title
Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Glimepiride+metformin (Amaryl M®) - HOE4900
Intervention Description
Pharmaceutical form:tablet Route of administration: oral
Primary Outcome Measure Information:
Title
Change in HbA1c
Time Frame
from baseline to week 24
Secondary Outcome Measure Information:
Title
Percentage of patients with HbA1c < 7%
Time Frame
at week 24
Title
Percentage of patients with HbA1c < 6.5%
Time Frame
at week 24
Title
Change in Fasting Plasma Glucose (FPG)
Time Frame
from baseline to week 24
Title
Number of patients with adverse events
Time Frame
over the 24-week treatment period
Title
Hypoglycemia
Time Frame
over the 24-week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 422-002
City
Beirut
Country
Lebanon
Facility Name
Investigational Site Number 422-001
City
Hazmieh
Country
Lebanon
Facility Name
Investigational Site Number 643001
City
Samara
Country
Russian Federation
Facility Name
Investigational Site Number 643002
City
St-Petersburg
Country
Russian Federation
Facility Name
Investigational Site Number 643-03
City
St.-Petersburg
Country
Russian Federation
Facility Name
Investigational Site Number 804003
City
Chernivtsi
ZIP/Postal Code
58022
Country
Ukraine
Facility Name
Investigational Site Number 804008
City
Donetsk
ZIP/Postal Code
83003
Country
Ukraine
Facility Name
Investigational Site Number 804004
City
Donetsk
ZIP/Postal Code
83059
Country
Ukraine
Facility Name
Investigational Site Number 804001
City
Donetsk
ZIP/Postal Code
83099
Country
Ukraine
Facility Name
Investigational Site Number 804010
City
Odessa
Country
Ukraine
Facility Name
Investigational Site Number 804006
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Investigational Site Number 804007
City
Vinnytsya
ZIP/Postal Code
21010
Country
Ukraine
Facility Name
Investigational Site Number 804002
City
Vinnytsya
ZIP/Postal Code
21029
Country
Ukraine

12. IPD Sharing Statement

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

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