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

January 19, 2015 updated by: Sanofi

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
538

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Algeries, Algeria
        • Investigational Site Number 01206
      • Oran, Algeria, 31000
        • Investigational Site Number 01203
      • Setif, Algeria, 19000
        • Investigational Site Number 01205
  • Colombia
      • El Espinal, Colombia
        • Investigational Site Number 17003
      • Manizales, Colombia, 170
        • Investigational Site Number 170001
  • Egypt
      • Cairo, Egypt
        • Investigational Site Number 81801
      • Cairo, Egypt
        • Investigational Site Number 81802
      • Cairo, Egypt
        • Investigational Site Number 81803
  • Guatemala
      • Guatemala, Guatemala
        • Investigational Site Number 32001
      • Guatemala, Guatemala
        • Investigational Site Number 32002
      • Guatemala, Guatemala
        • Investigational Site Number 32003
      • Guatemala, Guatemala
        • Investigational Site Number 32004
  • India
      • Bangalore, India, 560043
        • Investigational Site Number 356001
      • Bangalore, India, 560052
        • Investigational Site Number 356002
      • Ernakulam, India
        • Investigational Site Number 356006
      • Indore, India, 452010
        • Investigational Site Number 356003
      • Lucknow, India, 226003
        • Investigational Site Number 356009
      • Mumbai, India
        • Investigational Site Number 356010
      • Nashik, India, 422002
        • Investigational Site Number 356007
      • Pune, India, 411007
        • Investigational Site Number 356008
      • Varanasi, India
        • Investigational Site Number 356005
  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 1411413137
        • Investigational Site Number 364001
      • Tehran, Iran, Islamic Republic of, 1666694516
        • Investigational Site Number 364002
      • Tehran, Iran, Islamic Republic of
        • Investigational Site Number 36403
  • Lebanon
      • Beirut, Lebanon
        • Investigational Site Number 42201
      • Beirut, Lebanon
        • Investigational Site Number 42202
      • Chouf, Lebanon
        • Investigational Site Number 42203
      • Hazmieh, Lebanon
        • Investigational Site Number 422004
  • Mexico
      • Guadalajara, Mexico, 44340
        • Investigational Site Number 484002
      • Guadalajara, Mexico, 44670
        • Investigational Site Number 484003
  • Russian Federation
      • Moscow, Russian Federation, 119002
        • Investigational Site Number 643003
      • Saratov, Russian Federation, 410012
        • Investigational Site Number 643002
      • St.-Petersburg, Russian Federation
        • Investigational Site Number 643001
  • South Africa
      • Durban, South Africa, 4091
        • Investigational Site Number 710-002
      • Durban, South Africa, 4092
        • Investigational Site Number 710-001
  • Tunisia
      • La Marsa, Tunisia, 2070
        • Investigational Site Number 78803
      • La Marsa, Tunisia, 2070
        • Investigational Site Number 78804
      • Sfax, Tunisia
        • Investigational Site Number 78805
      • Tunis, Tunisia
        • Investigational Site Number 78801
      • Tunis, Tunisia
        • Investigational Site Number 78802
      • Tunis, Tunisia
        • Investigational Site Number 78806
      • Tunis, Tunisia
        • Investigational Site Number 78807
  • Turkey
      • Adana, Turkey
        • Investigational Site Number 792-004
      • Antalya, Turkey, 07070
        • Investigational Site Number 792-003
      • Istanbul, Turkey, 34722
        • Investigational Site Number 792-001
      • Istanbul, Turkey, 34890
        • Investigational Site Number 792-006
      • Kutahya, Turkey
        • Investigational Site Number 792-002
      • Sivas, Turkey, 58140
        • Investigational Site Number 792-005
  • Ukraine
      • Kyiv, Ukraine, 02175
        • Investigational Site Number 804001
      • Kyiv, Ukraine, 04114
        • Investigational Site Number 804002
      • Zaporozhye, Ukraine
        • Investigational Site Number 804003
  • United Arab Emirates
      • Dubai, United Arab Emirates
        • Investigational Site Number 784-001
      • Dubai, United Arab Emirates
        • Investigational Site Number 784-002
      • Dubai, United Arab Emirates
        • Investigational Site Number 784-003
      • Sharjah, United Arab Emirates, 46458
        • Investigational Site Number 784-004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • HOE490
Drug: METFORMIN

Pharmaceutical form: oral

Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in HbA1c
Time Frame: from baseline to week 24
from baseline to week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of patients with HbA1c < 7%
Time Frame: at week 24
at week 24
Percentage of patients with HbA1c < 6.5 %
Time Frame: at week 24
at week 24
Change in Fasting Plasma Glucose (FPG)
Time Frame: from baseline week 24
from baseline week 24
Number of patients reporting adverse events
Time Frame: overt the 24-weeks treatment period
overt the 24-weeks treatment period
Frequence and incidence of hypoglycemia
Time Frame: over the 24-weeks treatment period
over the 24-weeks treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GLIME_R_05809
  • U1111-1119-9984 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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