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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: GLIMEPIRIDE; Drug: METFORMIN

• Registration Number: NCT01459809
• Lead Sponsor: Sanofi

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 Timeline

• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-26
• Study Start: 2012-02
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 538

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM3: Glimepiride/metformin free combination	METFORMIN	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 ≤.
ARM 1: glimepiride alone	GLIMEPIRIDE	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 2: metformin alone	METFORMIN	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.
ARM3: Glimepiride/metformin free combination	GLIMEPIRIDE	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 ≤.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	from baseline to week 24

Secondary Outcome Measures

Name	Time	Method
Frequence and incidence of hypoglycemia	over the 24-weeks treatment period
Percentage of patients with HbA1c < 6.5 %	at week 24
Change in Fasting Plasma Glucose (FPG)	from baseline week 24
Percentage of patients with HbA1c < 7%	at week 24
Number of patients reporting adverse events	overt the 24-weeks treatment period

Trial Locations

Locations (55)

Investigational Site Number 792-002; 🇹🇷 Kutahya, Turkey

Investigational Site Number 784-001; 🇦🇪 Dubai, United Arab Emirates

Investigational Site Number 81802; 🇪🇬 Cairo, Egypt

Investigational Site Number 710-002; 🇿🇦 Durban, South Africa

Investigational Site Number 710-001; 🇿🇦 Durban, South Africa

Investigational Site Number 42203; 🇱🇧 Chouf, Lebanon

Investigational Site Number 81803; 🇪🇬 Cairo, Egypt

Investigational Site Number 422004; 🇱🇧 Hazmieh, Lebanon

Investigational Site Number 42202; 🇱🇧 Beirut, Lebanon

Investigational Site Number 81801; 🇪🇬 Cairo, Egypt

Investigational Site Number 643003; 🇷🇺 Moscow, Russian Federation

Investigational Site Number 792-004; 🇹🇷 Adana, Turkey

Investigational Site Number 42201; 🇱🇧 Beirut, Lebanon

Investigational Site Number 792-001; 🇹🇷 Istanbul, Turkey

Investigational Site Number 792-003; 🇹🇷 Antalya, Turkey

Investigational Site Number 643001; 🇷🇺 St.-Petersburg, Russian Federation

Investigational Site Number 643002; 🇷🇺 Saratov, Russian Federation

Investigational Site Number 792-005; 🇹🇷 Sivas, Turkey

Investigational Site Number 356001; 🇮🇳 Bangalore, India

Investigational Site Number 356007; 🇮🇳 Nashik, India

Investigational Site Number 484002; 🇲🇽 Guadalajara, Mexico

Investigational Site Number 78804; 🇹🇳 La Marsa, Tunisia

Investigational Site Number 78805; 🇹🇳 Sfax, Tunisia

Investigational Site Number 364001; 🇮🇷 Tehran, Iran, Islamic Republic of

Investigational Site Number 78801; 🇹🇳 Tunis, Tunisia

Investigational Site Number 78802; 🇹🇳 Tunis, Tunisia

Investigational Site Number 804001; 🇺🇦 Kyiv, Ukraine

Investigational Site Number 804002; 🇺🇦 Kyiv, Ukraine

Investigational Site Number 784-002; 🇦🇪 Dubai, United Arab Emirates

Investigational Site Number 364002; 🇮🇷 Tehran, Iran, Islamic Republic of

Investigational Site Number 36403; 🇮🇷 Tehran, Iran, Islamic Republic of

Investigational Site Number 484003; 🇲🇽 Guadalajara, Mexico

Investigational Site Number 78803; 🇹🇳 La Marsa, Tunisia

Investigational Site Number 78806; 🇹🇳 Tunis, Tunisia

Investigational Site Number 78807; 🇹🇳 Tunis, Tunisia

Investigational Site Number 784-003; 🇦🇪 Dubai, United Arab Emirates

Investigational Site Number 784-004; 🇦🇪 Sharjah, United Arab Emirates

Investigational Site Number 804003; 🇺🇦 Zaporozhye, Ukraine

Investigational Site Number 01206; 🇩🇿 Algeries, Algeria

Investigational Site Number 17003; 🇨🇴 El Espinal, Colombia

Investigational Site Number 01205; 🇩🇿 Setif, Algeria

Investigational Site Number 792-006; 🇹🇷 Istanbul, Turkey

Investigational Site Number 01203; 🇩🇿 Oran, Algeria

Investigational Site Number 170001; 🇨🇴 Manizales, Colombia

Investigational Site Number 32001; 🇬🇹 Guatemala, Guatemala

Investigational Site Number 32002; 🇬🇹 Guatemala, Guatemala

Investigational Site Number 32003; 🇬🇹 Guatemala, Guatemala

Investigational Site Number 32004; 🇬🇹 Guatemala, Guatemala

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 356008; 🇮🇳 Pune, India

Investigational Site Number 356005; 🇮🇳 Varanasi, India