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

This study is currently recruiting participants.
Verified May 2013 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01459809
First received: October 24, 2011
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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

Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: GLIMEPIRIDE
Drug: METFORMIN
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

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 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 ]

Estimated Enrollment: 600
Study Start Date: February 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: GLIMEPIRIDE

Pharmaceutical form: oral

Route of administration: oral

Other Name: HOE490
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.
 Drug: METFORMIN

Pharmaceutical form: oral

Route of administration: oral
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 ≤.
 Drug: GLIMEPIRIDE

Pharmaceutical form: oral

Route of administration: oral

Other Name: HOE490
Drug: METFORMIN

Pharmaceutical form: oral

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459809

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Show 54 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01459809     History of Changes
Other Study ID Numbers: GLIME_R_05809, U1111-1119-9984
Study First Received: October 24, 2011
Last Updated: May 15, 2013
Health Authority: Guatemala: Ministry of Public Health and Social Assistance

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
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013