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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01699932
First Posted: October 4, 2012
Last Update Posted: May 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose

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

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: Glimepiride+metformin (Amaryl M®) - HOE4900 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: from baseline to week 24 ]

Secondary Outcome Measures:
  • Percentage of patients with HbA1c < 7% [ Time Frame: at week 24 ]
  • Percentage of patients with HbA1c < 6.5% [ Time Frame: at week 24 ]
  • 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 ]
  • Hypoglycemia [ Time Frame: over the 24-week treatment period ]

Enrollment: 167
Study Start Date: September 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699932


Locations
Lebanon
Investigational Site Number 422-002
Beirut, Lebanon
Investigational Site Number 422-001
Hazmieh, Lebanon
Russian Federation
Investigational Site Number 643001
Samara, Russian Federation
Investigational Site Number 643002
St-Petersburg, Russian Federation
Investigational Site Number 643-03
St.-Petersburg, Russian Federation
Ukraine
Investigational Site Number 804003
Chernivtsi, Ukraine, 58022
Investigational Site Number 804008
Donetsk, Ukraine, 83003
Investigational Site Number 804004
Donetsk, Ukraine, 83059
Investigational Site Number 804001
Donetsk, Ukraine, 83099
Investigational Site Number 804010
Odessa, Ukraine
Investigational Site Number 804006
Poltava, Ukraine, 36011
Investigational Site Number 804007
Vinnytsya, Ukraine, 21010
Investigational Site Number 804002
Vinnytsya, Ukraine, 21029
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01699932     History of Changes
Other Study ID Numbers: GLMET_R_05823
U1111-1120-0058 ( Other Identifier: UTN )
First Submitted: September 26, 2012
First Posted: October 4, 2012
Last Update Posted: May 8, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors