Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin

NCT01457911 | Completed Phase 3

• 2 other identifiers: EFC11761U1111-1121-6792
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 22

Brief Summary

Primary Objective:

• To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. Secondary Objectives:
• To evaluate the percentage of patients reaching HbA1c \< 7% or HbA1c ≤ 6.5% of fixed dose combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
• To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
• To assess the safety and tolerability of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Absolute change in HbA1c

  20 weeks, from baseline to week 20

Secondary Outcomes (7)

• Percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5%, respectively

  20 weeks, at week 20

• Absolute change in Fasting Plasma Glucose

  20 weeks, from baseline to week 20

• Number of patients reporting adverse events

  20 weeks, from baseline to week 20

• Number of patients reporting serious adverse events

  20 weeks, from baseline to week 20

• Hypoglycemia

  20 weeks, from baseline to week 20

Study Arms (2)

AMARYL M (Glimepiride and Metformin hydrochloride combination)

EXPERIMENTAL

AMARYL M at a dosage regimen from 1 tablet to 6 tablets, once during a meal or twice during a meal

Drug: Glimepiride and Metformin hydrochloride combination (HOE490)

AMARYL (Glimepiride)

ACTIVE COMPARATOR

AMARYL at a dosage regimen from 1 mg to 6 mg, once during a meal or twice during a meal

Drug: Glimepiride (HOE490)

Interventions

Glimepiride and Metformin hydrochloride combination (HOE490) DRUG

Pharmaceutical form:tablet Route of administration: oral

AMARYL M (Glimepiride and Metformin hydrochloride combination)

Glimepiride (HOE490) DRUG

Pharmaceutical form:tablet Route of administration: oral

AMARYL (Glimepiride)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese patients with type 2 diabetes mellitus, as defined by World Health Organization, diagnosed for at least 1 year at the time of screening visit and inadequately controlled with metformin
• Signed written informed consent

You may not qualify if:

• Type 1 diabetes mellitus
• HbA1c \< 7% or \> 10%
• Fasting plasma glucose \> 250 mg/dL (\> 13.9 mmol/L)
• Age \<18 years or Age ≥ 80 years
• Patients who have not been on stable daily dose of at least 1500 mg metformin within 3 months prior to screening
• Patients currently receiving or who have received anti-diabetic drugs other than metformin within 3 months prior to screening
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (22)

Investigational Site Number 156001

Beijing, 100044, China

Location

Investigational Site Number 156016

Beijing, 100088, China

Location

Investigational Site Number 156003

Beijing, 100730, China

Location

Investigational Site Number 156018

Beijing, 100730, China

Location

Investigational Site Number 156002

Beijing, 100853, China

Location

Investigational Site Number 156019

Changchun, 130041, China

Location

Investigational Site Number 156017

Chengdu, 610083, China

Location

Investigational Site Number 156014

Guangzhou, 510080, China

Location

Investigational Site Number 156022

Guangzhou, 510150, China

Location

Investigational Site Number 156011

Hangzhou, 310003, China

Location

Investigational Site Number 156012

Hefei, 230001, China

Location

Investigational Site Number 156020

Jinan, 250012, China

Location

Investigational Site Number 156023

Jinan, 250021, China

Location

Investigational Site Number 156010

Shanghai, 200040, China

Location

Investigational Site Number 156006

Shanghai, 200072, China

Location

Investigational Site Number 156009

Shanghai, 200080, China

Location

Investigational Site Number 156021

Shenyang, 110022, China

Location

Investigational Site Number 156005

Shijiazhuang, 050051, China

Location

Investigational Site Number 156004

Taiyuan, 030001, China

Location

Investigational Site Number 156024

Tianjin, 300052, China

Location

Investigational Site Number 156008

Wuhan, 430022, China

Location

Investigational Site Number 156015

Xiamen, 361003, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 24, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 8, 2014

Record last verified: 2014-05

Locations

CN (22)