search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GLIMEPIRIDE
METFORMIN
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 01206
  • Investigational Site Number 01203
  • Investigational Site Number 01205
  • Investigational Site Number 17003
  • Investigational Site Number 170001
  • Investigational Site Number 81801
  • Investigational Site Number 81802
  • Investigational Site Number 81803
  • Investigational Site Number 32001
  • Investigational Site Number 32002
  • Investigational Site Number 32003
  • Investigational Site Number 32004
  • Investigational Site Number 356001
  • Investigational Site Number 356002
  • Investigational Site Number 356006
  • Investigational Site Number 356003
  • Investigational Site Number 356009
  • Investigational Site Number 356010
  • Investigational Site Number 356007
  • Investigational Site Number 356008
  • Investigational Site Number 356005
  • Investigational Site Number 364001
  • Investigational Site Number 364002
  • Investigational Site Number 36403
  • Investigational Site Number 42201
  • Investigational Site Number 42202
  • Investigational Site Number 42203
  • Investigational Site Number 422004
  • Investigational Site Number 484002
  • Investigational Site Number 484003
  • Investigational Site Number 643003
  • Investigational Site Number 643002
  • Investigational Site Number 643001
  • Investigational Site Number 710-002
  • Investigational Site Number 710-001
  • Investigational Site Number 78803
  • Investigational Site Number 78804
  • Investigational Site Number 78805
  • Investigational Site Number 78801
  • Investigational Site Number 78802
  • Investigational Site Number 78806
  • Investigational Site Number 78807
  • Investigational Site Number 792-004
  • Investigational Site Number 792-003
  • Investigational Site Number 792-001
  • Investigational Site Number 792-006
  • Investigational Site Number 792-002
  • Investigational Site Number 792-005
  • Investigational Site Number 804001
  • Investigational Site Number 804002
  • Investigational Site Number 804003
  • Investigational Site Number 784-001
  • Investigational Site Number 784-002
  • Investigational Site Number 784-003
  • Investigational Site Number 784-004

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

ARM 1: glimepiride alone

ARM 2: metformin alone

ARM3: Glimepiride/metformin free combination

Arm Description

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.

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.

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 ≤.

Outcomes

Primary Outcome Measures

Change in HbA1c

Secondary Outcome Measures

Percentage of patients with HbA1c < 7%
Percentage of patients with HbA1c < 6.5 %
Change in Fasting Plasma Glucose (FPG)
Number of patients reporting adverse events
Frequence and incidence of hypoglycemia

Full Information

First Posted
October 24, 2011
Last Updated
January 19, 2015
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT01459809
Brief Title
Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients
Acronym
RECOMMEND
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
538 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARM 1: glimepiride alone
Arm Type
Experimental
Arm Description
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.
Arm Title
ARM 2: metformin alone
Arm Type
Experimental
Arm Description
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.
Arm Title
ARM3: Glimepiride/metformin free combination
Arm Type
Experimental
Arm Description
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 ≤.
Intervention Type
Drug
Intervention Name(s)
GLIMEPIRIDE
Other Intervention Name(s)
HOE490
Intervention Description
Pharmaceutical form: oral Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
METFORMIN
Intervention Description
Pharmaceutical form: oral Route of administration: oral
Primary Outcome Measure Information:
Title
Change in HbA1c
Time Frame
from baseline to week 24
Secondary Outcome Measure Information:
Title
Percentage of patients with HbA1c < 7%
Time Frame
at week 24
Title
Percentage of patients with HbA1c < 6.5 %
Time Frame
at week 24
Title
Change in Fasting Plasma Glucose (FPG)
Time Frame
from baseline week 24
Title
Number of patients reporting adverse events
Time Frame
overt the 24-weeks treatment period
Title
Frequence and incidence of hypoglycemia
Time Frame
over the 24-weeks treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 01206
City
Algeries
Country
Algeria
Facility Name
Investigational Site Number 01203
City
Oran
ZIP/Postal Code
31000
Country
Algeria
Facility Name
Investigational Site Number 01205
City
Setif
ZIP/Postal Code
19000
Country
Algeria
Facility Name
Investigational Site Number 17003
City
El Espinal
Country
Colombia
Facility Name
Investigational Site Number 170001
City
Manizales
ZIP/Postal Code
170
Country
Colombia
Facility Name
Investigational Site Number 81801
City
Cairo
Country
Egypt
Facility Name
Investigational Site Number 81802
City
Cairo
Country
Egypt
Facility Name
Investigational Site Number 81803
City
Cairo
Country
Egypt
Facility Name
Investigational Site Number 32001
City
Guatemala
Country
Guatemala
Facility Name
Investigational Site Number 32002
City
Guatemala
Country
Guatemala
Facility Name
Investigational Site Number 32003
City
Guatemala
Country
Guatemala
Facility Name
Investigational Site Number 32004
City
Guatemala
Country
Guatemala
Facility Name
Investigational Site Number 356001
City
Bangalore
ZIP/Postal Code
560043
Country
India
Facility Name
Investigational Site Number 356002
City
Bangalore
ZIP/Postal Code
560052
Country
India
Facility Name
Investigational Site Number 356006
City
Ernakulam
Country
India
Facility Name
Investigational Site Number 356003
City
Indore
ZIP/Postal Code
452010
Country
India
Facility Name
Investigational Site Number 356009
City
Lucknow
ZIP/Postal Code
226003
Country
India
Facility Name
Investigational Site Number 356010
City
Mumbai
Country
India
Facility Name
Investigational Site Number 356007
City
Nashik
ZIP/Postal Code
422002
Country
India
Facility Name
Investigational Site Number 356008
City
Pune
ZIP/Postal Code
411007
Country
India
Facility Name
Investigational Site Number 356005
City
Varanasi
Country
India
Facility Name
Investigational Site Number 364001
City
Tehran
ZIP/Postal Code
1411413137
Country
Iran, Islamic Republic of
Facility Name
Investigational Site Number 364002
City
Tehran
ZIP/Postal Code
1666694516
Country
Iran, Islamic Republic of
Facility Name
Investigational Site Number 36403
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Investigational Site Number 42201
City
Beirut
Country
Lebanon
Facility Name
Investigational Site Number 42202
City
Beirut
Country
Lebanon
Facility Name
Investigational Site Number 42203
City
Chouf
Country
Lebanon
Facility Name
Investigational Site Number 422004
City
Hazmieh
Country
Lebanon
Facility Name
Investigational Site Number 484002
City
Guadalajara
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Investigational Site Number 484003
City
Guadalajara
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Investigational Site Number 643003
City
Moscow
ZIP/Postal Code
119002
Country
Russian Federation
Facility Name
Investigational Site Number 643002
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Investigational Site Number 643001
City
St.-Petersburg
Country
Russian Federation
Facility Name
Investigational Site Number 710-002
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Investigational Site Number 710-001
City
Durban
ZIP/Postal Code
4092
Country
South Africa
Facility Name
Investigational Site Number 78803
City
La Marsa
ZIP/Postal Code
2070
Country
Tunisia
Facility Name
Investigational Site Number 78804
City
La Marsa
ZIP/Postal Code
2070
Country
Tunisia
Facility Name
Investigational Site Number 78805
City
Sfax
Country
Tunisia
Facility Name
Investigational Site Number 78801
City
Tunis
Country
Tunisia
Facility Name
Investigational Site Number 78802
City
Tunis
Country
Tunisia
Facility Name
Investigational Site Number 78806
City
Tunis
Country
Tunisia
Facility Name
Investigational Site Number 78807
City
Tunis
Country
Tunisia
Facility Name
Investigational Site Number 792-004
City
Adana
Country
Turkey
Facility Name
Investigational Site Number 792-003
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Investigational Site Number 792-001
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Investigational Site Number 792-006
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Investigational Site Number 792-002
City
Kutahya
Country
Turkey
Facility Name
Investigational Site Number 792-005
City
Sivas
ZIP/Postal Code
58140
Country
Turkey
Facility Name
Investigational Site Number 804001
City
Kyiv
ZIP/Postal Code
02175
Country
Ukraine
Facility Name
Investigational Site Number 804002
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Investigational Site Number 804003
City
Zaporozhye
Country
Ukraine
Facility Name
Investigational Site Number 784-001
City
Dubai
Country
United Arab Emirates
Facility Name
Investigational Site Number 784-002
City
Dubai
Country
United Arab Emirates
Facility Name
Investigational Site Number 784-003
City
Dubai
Country
United Arab Emirates
Facility Name
Investigational Site Number 784-004
City
Sharjah
ZIP/Postal Code
46458
Country
United Arab Emirates

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs