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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

538

Phase

  • 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

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
Intervention / Treatment
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

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: from baseline to week 24
from baseline to week 24

Secondary Outcome Measures

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

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

February 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

October 24, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (Estimate)

October 26, 2011

Study Record Updates

Last Update Posted (Estimate)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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