Initiation and Titration of Amaryl (AMIT KZ)

January 28, 2011 updated by: Sanofi

AMIT Study - Amaryl M Initiation and Titration Study

Primary Objective:

  • To describe the conditions of initiation and titration of Amaryl M, according to previous treatment:
  • initial dose
  • titration scheme
  • efficacy after 4 months assessed by HbA1C
  • tolerability (number and severity of hypoglycaemia)

Secondary Objective:

  • Fasting Plasma Glucose
  • Weight evolution

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Almaty, Kazakhstan
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients with Type 2 diabetes who have been treated with a stable dose (any dose) of :
  • sulfonylurea monotherapy or
  • metformin monotherapy or
  • free combination of glimepiride and metformin with a stable dose (any dose)
  • Body Mass Index (BMI) between 20 and 40 kg/m2
  • HbA1c superior or egal to 7.5%
  • FPG superior or egal 7 mmol/l

Exclusion criteria:

  • Secondary or insulin-dependant diabetes
  • Any severe chronic disease (hepatic, renal impairments)
  • History of major cardiovascular event in the last 6 months
  • Acute conditions with the potential to alter renal function such as: dehydratation, severe infection, shock, IV administration of iodinated contrast agents
  • Allergy to sulfonylurea, metformin
  • Drug or alcohol abuse
  • Pregnancy, lactation

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Single arm Glimepiride+metformin
Start and titration based on FBG and tolerance. Titration should be achieved within maximum 4 weeks.
Drug: GLIMEPIRIDE + METFORMIN
Pharmaceutical form: Tablet Route of administration: oral Dose regimen : fixed dose combination of glimepiride / metformin: 1/250, 2/500

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycolysated Haemoglobin (HbA1c)
Time Frame: From baseline to Month 4
From baseline to Month 4
Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%
Time Frame: Month 4
Month 4
Evolution of Fasting Plasma Glucose (FPG)
Time Frame: From baseline to Months 4
From baseline to Months 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Post Prandial Plasma Glucose (PPPG)
Time Frame: Month 4
Month 4
Number of patients for each start dose
Time Frame: At baseline
At baseline
Number of patients with different final doses
Time Frame: Month 4
Month 4
Rate of Symptomatic Hypoglycemia
Time Frame: During treatment period (4 months)
During treatment period (4 months)
Change in Weight
Time Frame: Month 4
Month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

June 14, 2010

First Posted (ESTIMATE)

June 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 31, 2011

Last Update Submitted That Met QC Criteria

January 28, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLMET_L_04718
  • U1111-1116-9956 (OTHER: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on GLIMEPIRIDE + METFORMIN

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe