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:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01699932
First received: September 26, 2012
Last updated: May 7, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with HbA1c < 7% [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Percentage of patients with HbA1c < 6.5% [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: over the 24-week treatment period ] [ Designated as safety issue: Yes ]
  • Hypoglycemia [ Time Frame: over the 24-week treatment period ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 804004
Donetsk, Ukraine, 83059
Investigational Site Number 804008
Donetsk, Ukraine, 83003
Investigational Site Number 804001
Donetsk, Ukraine, 83099
Investigational Site Number 804010
Odessa, Ukraine
Investigational Site Number 804006
Poltava, Ukraine, 36011
Investigational Site Number 804002
Vinnytsya, Ukraine, 21029
Investigational Site Number 804007
Vinnytsya, Ukraine, 21010
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01699932     History of Changes
Other Study ID Numbers: GLMET_R_05823, U1111-1120-0058
Study First Received: September 26, 2012
Last Updated: May 7, 2014
Health Authority: Lebanon: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014