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
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
Change in Fasting Plasma Glucose (FPG)	from baseline to week 24
Number of patients with adverse events	over the 24-week treatment period

Trial Locations

Locations (13)

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

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

Investigational Site Number 643001; 🇷🇺 Samara, Russian Federation

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

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

Investigational Site Number 804003; 🇺🇦 Chernivtsi, Ukraine

Investigational Site Number 804008; 🇺🇦 Donetsk, Ukraine

Investigational Site Number 804004; 🇺🇦 Donetsk, Ukraine

Investigational Site Number 804001; 🇺🇦 Donetsk, Ukraine

Investigational Site Number 804010; 🇺🇦 Odessa, Ukraine

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