Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Glimepiride+metformin (Amaryl M®) - HOE4900

• Registration Number: NCT01699932
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-26
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-07
• Last Update Posted: 2014-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Glimepiride+metformin (Amaryl M®) - HOE4900	24-week treatment period: starting dose will be of 2/1000 mg or 4/2000 mg of glimepiride/metformin fixed combination (Amaryl M® ) depending on the previous treatment and dose. The Interventional medicinal product's dose will be increased every 2 weeks up to the maximum tolerated dose of 8/2000 mg of Amaryl M® , 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.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	from baseline to week 24

Secondary Outcome Measures

Name	Time	Method
Change in Fasting Plasma Glucose (FPG)	from baseline to week 24
Percentage of patients with HbA1c < 6.5%	at week 24
Hypoglycemia	over the 24-week treatment period
Percentage of patients with HbA1c < 7%	at week 24
Number of patients with adverse events	over the 24-week treatment period

Trial Locations

Locations (13)

Investigational Site Number 804002; 🇺🇦 Vinnytsya, Ukraine

Investigational Site Number 422-002; 🇱🇧 Beirut, Lebanon

Investigational Site Number 422-001; 🇱🇧 Hazmieh, Lebanon

Investigational Site Number 643001; 🇷🇺 Samara, Russian Federation

Investigational Site Number 804003; 🇺🇦 Chernivtsi, Ukraine

Investigational Site Number 804008; 🇺🇦 Donetsk, Ukraine

Investigational Site Number 643002; 🇷🇺 St-Petersburg, Russian Federation

Investigational Site Number 643-03; 🇷🇺 St.-Petersburg, Russian Federation

Investigational Site Number 804006; 🇺🇦 Poltava, Ukraine

Investigational Site Number 804007; 🇺🇦 Vinnytsya, Ukraine

Investigational Site Number 804004; 🇺🇦 Donetsk, Ukraine

Investigational Site Number 804001; 🇺🇦 Donetsk, Ukraine

Investigational Site Number 804010; 🇺🇦 Odessa, Ukraine