Clinical trial NCT01699932: Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled
Official title: A Multinational, Open Label, Non Comparative, 24-week Study to Evaluate the Blood Glucose Lowering Efficacy and Safety of a Fixed Dose Combination of Glimepiride and Metformin in Patients With Inadequately Controlled Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-10-04
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

-To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of HbA1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus.

Secondary Objective:

To assess the effects of the fixed combination of glimepiride and metformin at week 24 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 and 3 days follow-up period with a last call phone visit.

Eligibility criteria: Inclusion criteria:

* Patients with type 2 diabetes mellitus inadequately controlled despite a treatment with sulfonylurea (SU) alone or metformin alone or a free combination of SU and metformin prior to the study entry.
* Signed informed consent, obtained prior any study procedure

Exclusion criteria:

* Age \< legal age of adulthood
* HbA1c \< 7% or ≥ 11%
* BMI \> 35 kg/m2
* Treatment with a stable dose of maximally tolerated SU alone or metformin alone or the free combination of SU and metformin for less than 12 weeks prior to the screening visit.
* Patients who received any anti-diabetic drug other than SU or metformin within 12 weeks prior to the screening visit.
* Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake...)

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 to week 24
measure: Number of patients with adverse events
timeFrame: over the 24-week treatment period
measure: Hypoglycemia
timeFrame: over the 24-week treatment period
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Investigational Site Number 422-002
city: Hazmieh
country: Lebanon
facility: Investigational Site Number 422-001
city: Samara
country: Russian Federation
facility: Investigational Site Number 643001
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643002
city: St.-Petersburg
country: Russian Federation
facility: Investigational Site Number 643-03
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number 804003
city: Donetsk
country: Ukraine
facility: Investigational Site Number 804008
city: Donetsk
country: Ukraine
facility: Investigational Site Number 804004
city: Donetsk
country: Ukraine
facility: Investigational Site Number 804001
city: Odessa
country: Ukraine
facility: Investigational Site Number 804010
city: Poltava
country: Ukraine
facility: Investigational Site Number 804006
city: Vinnytsya
country: Ukraine
facility: Investigational Site Number 804007
city: Vinnytsya
country: Ukraine
facility: Investigational Site Number 804002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: