Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients (RECOMMEND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01459809
First received: October 24, 2011
Last updated: February 4, 2014
Last verified: February 2014

October 24, 2011
February 4, 2014
February 2012
January 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 NCT01459809 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 week 24 ] [ Designated as safety issue: No ]
  • Number of patients reporting adverse events [ Time Frame: overt the 24-weeks treatment period ] [ Designated as safety issue: Yes ]
  • Frequence and incidence of hypoglycemia [ Time Frame: over the 24-weeks treatment period ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients
A Multinational, Open Label, Randomized, Active-controlled, 3-arm Parallel Group, 24-week Study Comparing the Combination of Glimepiride and Metformin Versus Glimepiride and Metformin Alone in Patients With Type 2 Diabetes

Primary Objective:

- To demonstrate the superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus.

Secondary Objectives:

- To assess the effects of the free combination of glimepiride and metformin in comparison to glimepiride or metformin alone 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 where patient is assigned to one of the three arms according to randomization, and 3 days follow-up period with a last call phone visit.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: GLIMEPIRIDE

    Pharmaceutical form: oral

    Route of administration: oral

    Other Name: HOE490
  • Drug: METFORMIN

    Pharmaceutical form: oral

    Route of administration: oral

  • Experimental: ARM 1: glimepiride alone
    24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if Fasting Plasma Glucose (FPG) at baseline < 180 mg/dL (10 mmol/L) taken once in the morning before breakfast. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg, 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
  • Experimental: ARM 2: metformin alone
    24-week treatment period: After randomization, starting dose will be of 500 mg of metformin twice a day during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 2000 mg, and adjusted throughout the 24-week treatment period according to fasting 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: METFORMIN
  • Experimental: ARM3: Glimepiride/metformin free combination
    24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if FPG at baseline < 180 mg/dL (10 mmol/L) taken once in the morning and 500 mg of metformin twice a day taken during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg of glimepiride and 2000 mg of metformin, and adjusted throughout the 24-week treatment period according to fasting SMPG values in the objective to obtain values ≤.
    Interventions:
    • Drug: GLIMEPIRIDE
    • Drug: METFORMIN
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
542
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion criteria

  • Patients with type 2 diabetes mellitus, as defined by the World Health Organization (WHO), diagnosed within one year prior to the screening visit
  • Signed informed consent, obtained prior to any study procedure

Exclusion criteria

  • Age < 18 and => 78 years old
  • HbA1c < 7.6% or > 9%
  • BMI > 35 kg/m2
  • Diabetes other than type 2 diabetes (e.g.: type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake...)
  • Subjects currently receiving or who have received any hypoglycemic agent within 3 months before screening visit

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Both
18 Years to 78 Years
No
Contact information is only displayed when the study is recruiting subjects
Saudi Arabia,   Algeria,   Colombia,   Guatemala,   India,   Iran, Islamic Republic of,   Lebanon,   Mexico,   Russian Federation,   South Africa,   United Arab Emirates,   Tunisia,   Turkey,   Ukraine,   Egypt
 
NCT01459809
GLIME_R_05809, U1111-1119-9984
Yes
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
February 2014

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