Clinical trial NCT01459809: Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-10-26
Enrollment: 538
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: from baseline to week 24
Secondary outcomes:
measure: Percentage of patients with HbA1c < 7%
timeFrame: at week 24
measure: Percentage of patients with HbA1c < 6.5 %
timeFrame: at week 24
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: from baseline week 24
measure: Number of patients reporting adverse events
timeFrame: overt the 24-weeks treatment period
measure: Frequence and incidence of hypoglycemia
timeFrame: over the 24-weeks treatment period
Other outcomes:
Locations:
city: Algeries
country: Algeria
facility: Investigational Site Number 01206
city: Oran
country: Algeria
facility: Investigational Site Number 01203
city: Setif
country: Algeria
facility: Investigational Site Number 01205
city: El Espinal
country: Colombia
facility: Investigational Site Number 17003
city: Manizales
country: Colombia
facility: Investigational Site Number 170001
city: Cairo
country: Egypt
facility: Investigational Site Number 81801
city: Cairo
country: Egypt
facility: Investigational Site Number 81802
city: Cairo
country: Egypt
facility: Investigational Site Number 81803
city: Guatemala
country: Guatemala
facility: Investigational Site Number 32001
city: Guatemala
country: Guatemala
facility: Investigational Site Number 32002
city: Guatemala
country: Guatemala
facility: Investigational Site Number 32003
city: Guatemala
country: Guatemala
facility: Investigational Site Number 32004
city: Bangalore
country: India
facility: Investigational Site Number 356001
city: Bangalore
country: India
facility: Investigational Site Number 356002
city: Ernakulam
country: India
facility: Investigational Site Number 356006
city: Indore
country: India
facility: Investigational Site Number 356003
city: Lucknow
country: India
facility: Investigational Site Number 356009
city: Mumbai
country: India
facility: Investigational Site Number 356010
city: Nashik
country: India
facility: Investigational Site Number 356007
city: Pune
country: India
facility: Investigational Site Number 356008
city: Varanasi
country: India
facility: Investigational Site Number 356005
city: Tehran
country: Iran, Islamic Republic of
facility: Investigational Site Number 364001
city: Tehran
country: Iran, Islamic Republic of
facility: Investigational Site Number 364002
city: Tehran
country: Iran, Islamic Republic of
facility: Investigational Site Number 36403
city: Beirut
country: Lebanon
facility: Investigational Site Number 42201
city: Beirut
country: Lebanon
facility: Investigational Site Number 42202
city: Chouf
country: Lebanon
facility: Investigational Site Number 42203
city: Hazmieh
country: Lebanon
facility: Investigational Site Number 422004
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484002
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484003
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643003
city: Saratov
country: Russian Federation
facility: Investigational Site Number 643002
city: St.-Petersburg
country: Russian Federation
facility: Investigational Site Number 643001
city: Durban
country: South Africa
facility: Investigational Site Number 710-002
city: Durban
country: South Africa
facility: Investigational Site Number 710-001
city: La Marsa
country: Tunisia
facility: Investigational Site Number 78803
city: La Marsa
country: Tunisia
facility: Investigational Site Number 78804
city: Sfax
country: Tunisia
facility: Investigational Site Number 78805
city: Tunis
country: Tunisia
facility: Investigational Site Number 78801
city: Tunis
country: Tunisia
facility: Investigational Site Number 78802
city: Tunis
country: Tunisia
facility: Investigational Site Number 78806
city: Tunis
country: Tunisia
facility: Investigational Site Number 78807
city: Adana
country: Turkey
facility: Investigational Site Number 792-004
city: Antalya
country: Turkey
facility: Investigational Site Number 792-003
city: Istanbul
country: Turkey
facility: Investigational Site Number 792-001
city: Istanbul
country: Turkey
facility: Investigational Site Number 792-006
city: Kutahya
country: Turkey
facility: Investigational Site Number 792-002
city: Sivas
country: Turkey
facility: Investigational Site Number 792-005
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804001
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804002
city: Zaporozhye
country: Ukraine
facility: Investigational Site Number 804003
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 784-001
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 784-002
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 784-003
city: Sharjah
country: United Arab Emirates
facility: Investigational Site Number 784-004
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: