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

Overview[ - collapse ][ - ]

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
ConditionDiabetes Mellitus, Type 2
InterventionDrug: GLIMEPIRIDE
Drug: METFORMIN
PhasePhase 3
SponsorSanofi
Responsible PartySanofi
ClinicalTrials.gov IdentifierNCT01459809
First ReceivedOctober 24, 2011
Last UpdatedFebruary 4, 2014
Last verifiedFebruary 2014

Tracking Information[ + expand ][ + ]

First Received DateOctober 24, 2011
Last Updated DateFebruary 4, 2014
Start DateFebruary 2012
Estimated Primary Completion DateJanuary 2014
Current Primary Outcome MeasuresChange in HbA1c [Time Frame: from baseline to week 24] [Designated as safety issue: No]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients
Official TitleA 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
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.
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionDiabetes Mellitus, Type 2
InterventionDrug: GLIMEPIRIDE
Pharmaceutical form: oral
Route of administration: oral
Other Names:
HOE490Drug: METFORMIN
Pharmaceutical form: oral
Route of administration: oral
Study Arm (s)
  • 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.
  • 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.
  • 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 ≤.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment542
Estimated Completion DateJanuary 2014
Estimated Primary Completion DateJanuary 2014
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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesAlgeria, Colombia, Egypt, Guatemala, India, Iran, Islamic Republic of, Lebanon, Mexico, Russian Federation, Saudi Arabia, South Africa, Tunisia, Turkey, Ukraine, United Arab Emirates

Administrative Information[ + expand ][ + ]

NCT Number NCT01459809
Other Study ID NumbersGLIME_R_05809
Has Data Monitoring CommitteeYes
Information Provided BySanofi
Study SponsorSanofi
CollaboratorsNot Provided
Investigators Study Director: Clinical Sciences & Operations Sanofi
Verification DateFebruary 2014

Locations[ + expand ][ + ]

Investigational Site Number 01206
Algeries, Algeria
Investigational Site Number 01201
Algiers, Algeria, 16000
Investigational Site Number 01202
Algiers, Algeria
Investigational Site Number 01203
Oran, Algeria, 31000
Investigational Site Number 01205
Setif, Algeria, 19000
Investigational Site Number 17003
El Espinal, Colombia
Investigational Site Number 170001
Manizales, Colombia, 170
Investigational Site Number 170002
Pereira, Colombia, 170
Investigational Site Number 81801
Cairo, Egypt
Investigational Site Number 81803
Cairo, Egypt
Investigational Site Number 32002
Guatemala, Guatemala
Investigational Site Number 32003
Guatemala, Guatemala
Investigational Site Number 32004
Guatemala, Guatemala
Investigational Site Number 32001
Guatemala, Guatemala
Investigational Site Number 356001
Bangalore, India, 560043
Investigational Site Number 356002
Bangalore, India, 560052
Investigational Site Number 356006
Ernakulam, India
Investigational Site Number 356003
Indore, India, 452010
Investigational Site Number 356004
Kolkata, India, 700054
Investigational Site Number 356009
Lucknow, India, 226003
Investigational Site Number 356010
Mumbai, India
Investigational Site Number 356007
Nashik, India, 422002
Investigational Site Number 356008
Pune, India, 411007
Investigational Site Number 356005
Varanasi, India
Investigational Site Number 364001
Tehran, Iran, Islamic Republic of, 1411413137
Investigational Site Number 364002
Tehran, Iran, Islamic Republic of, 1666694516
Investigational Site Number 36403
Tehran, Iran, Islamic Republic of
Investigational Site Number 42202
Beirut, Lebanon
Investigational Site Number 42201
Beirut, Lebanon
Investigational Site Number 42203
Chouf, Lebanon
Investigational Site Number 422004
Hazmieh, Lebanon
Investigational Site Number 484002
Guadalajara, Mexico, 44340
Investigational Site Number 484003
Guadalajara, Mexico, 44670
Investigational Site Number 643003
Moscow, Russian Federation, 119002
Investigational Site Number 643002
Saratov, Russian Federation, 410012
Investigational Site Number 643001
St.-Petersburg, Russian Federation
Investigational Site Number 01
Dammam, Saudi Arabia, 31444
Investigational Site Number 710-003
Bloemfontein, South Africa, 9301
Investigational Site Number 710-002
Durban, South Africa, 4091
Investigational Site Number 710-001
Durban, South Africa, 4092
Investigational Site Number 710-005
Pretoiria, South Africa
Investigational Site Number 78804
La Marsa, Tunisia, 2070
Investigational Site Number 78803
La Marsa, Tunisia, 2070
Investigational Site Number 78805
Sfax, Tunisia
Investigational Site Number 78802
Tunis, Tunisia
Investigational Site Number 78801
Tunis, Tunisia
Investigational Site Number 78806
Tunis, Tunisia
Investigational Site Number 78807
Tunis, Tunisia
Investigational Site Number 792-004
Adana, Turkey
Investigational Site Number 792-003
Antalya, Turkey, 07070
Investigational Site Number 792-001
Istanbul, Turkey, 34722
Investigational Site Number 792-006
Istanbul, Turkey, 34890
Investigational Site Number 792-002
Kutahya, Turkey
Investigational Site Number 792-005
Sivas, Turkey, 58140
Investigational Site Number 804001
Kyiv, Ukraine, 02175
Investigational Site Number 804002
Kyiv, Ukraine, 04114
Investigational Site Number 804003
Zaporozhye, Ukraine
Investigational Site Number 784-001
Dubai, United Arab Emirates
Investigational Site Number 784-003
Dubai, United Arab Emirates
Investigational Site Number 784-002
Dubai, United Arab Emirates
Investigational Site Number 784-004
Sharjah, United Arab Emirates, 46458