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

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459809
• Other study ID #: GLIME_R_05809
• Secondary ID: U1111-1119-9984
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2011
• Last updated: January 19, 2015
• Start date: February 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Guatemala: Ministry of Public Health and Social Assistance
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 538
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• GLIMEPIRIDE
Pharmaceutical form: oral Route of administration: oral
• METFORMIN
Pharmaceutical form: oral Route of administration: oral

Locations

Country	Name	City	State
Algeria	Investigational Site Number 01206	Algeries
Algeria	Investigational Site Number 01203	Oran
Algeria	Investigational Site Number 01205	Setif
Colombia	Investigational Site Number 17003	El Espinal
Colombia	Investigational Site Number 170001	Manizales
Egypt	Investigational Site Number 81801	Cairo
Egypt	Investigational Site Number 81802	Cairo
Egypt	Investigational Site Number 81803	Cairo
Guatemala	Investigational Site Number 32001	Guatemala
Guatemala	Investigational Site Number 32002	Guatemala
Guatemala	Investigational Site Number 32003	Guatemala
Guatemala	Investigational Site Number 32004	Guatemala
India	Investigational Site Number 356001	Bangalore
India	Investigational Site Number 356002	Bangalore
India	Investigational Site Number 356006	Ernakulam
India	Investigational Site Number 356003	Indore
India	Investigational Site Number 356009	Lucknow
India	Investigational Site Number 356010	Mumbai
India	Investigational Site Number 356007	Nashik
India	Investigational Site Number 356008	Pune
India	Investigational Site Number 356005	Varanasi
Iran, Islamic Republic of	Investigational Site Number 364001	Tehran
Iran, Islamic Republic of	Investigational Site Number 364002	Tehran
Iran, Islamic Republic of	Investigational Site Number 36403	Tehran
Lebanon	Investigational Site Number 42201	Beirut
Lebanon	Investigational Site Number 42202	Beirut
Lebanon	Investigational Site Number 42203	Chouf
Lebanon	Investigational Site Number 422004	Hazmieh
Mexico	Investigational Site Number 484002	Guadalajara
Mexico	Investigational Site Number 484003	Guadalajara
Russian Federation	Investigational Site Number 643003	Moscow
Russian Federation	Investigational Site Number 643002	Saratov
Russian Federation	Investigational Site Number 643001	St.-Petersburg
South Africa	Investigational Site Number 710-001	Durban
South Africa	Investigational Site Number 710-002	Durban
Tunisia	Investigational Site Number 78803	La Marsa
Tunisia	Investigational Site Number 78804	La Marsa
Tunisia	Investigational Site Number 78805	Sfax
Tunisia	Investigational Site Number 78801	Tunis
Tunisia	Investigational Site Number 78802	Tunis
Tunisia	Investigational Site Number 78806	Tunis
Tunisia	Investigational Site Number 78807	Tunis
Turkey	Investigational Site Number 792-004	Adana
Turkey	Investigational Site Number 792-003	Antalya
Turkey	Investigational Site Number 792-001	Istanbul
Turkey	Investigational Site Number 792-006	Istanbul
Turkey	Investigational Site Number 792-002	Kutahya
Turkey	Investigational Site Number 792-005	Sivas
Ukraine	Investigational Site Number 804001	Kyiv
Ukraine	Investigational Site Number 804002	Kyiv
Ukraine	Investigational Site Number 804003	Zaporozhye
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	Dubai
United Arab Emirates	Investigational Site Number 784-004	Sharjah

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Algeria,  Colombia,  Egypt,  Guatemala,  India,  Iran, Islamic Republic of,  Lebanon,  Mexico,  Russian Federation,  South Africa,  Tunisia,  Turkey,  Ukraine,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		from baseline to week 24	No
Secondary	Percentage of patients with HbA1c < 7%		at week 24	No
Secondary	Percentage of patients with HbA1c < 6.5 %		at week 24	No
Secondary	Change in Fasting Plasma Glucose (FPG)		from baseline week 24	No
Secondary	Number of patients reporting adverse events		overt the 24-weeks treatment period	Yes
Secondary	Frequence and incidence of hypoglycemia		over the 24-weeks treatment period	Yes