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

September 26, 2012
May 7, 2014
September 2012
April 2014   (final data collection date for primary outcome measure)
Change in HbA1c [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01699932 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled
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

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: Glimepiride+metformin (Amaryl M®) - HOE4900

Pharmaceutical form:tablet

Route of administration: oral

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.
Intervention: Drug: Glimepiride+metformin (Amaryl M®) - HOE4900
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
167
April 2014
April 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Lebanon,   Russian Federation,   Ukraine
 
NCT01699932
GLMET_R_05823, U1111-1120-0058
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP