Initiation and Titration of Amaryl (AMIT KZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01144728
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : January 31, 2011
Information provided by:

June 14, 2010
June 16, 2010
January 31, 2011
May 2010
December 2010   (Final data collection date for primary outcome measure)
  • Glycolysated Haemoglobin (HbA1c) [ Time Frame: From baseline to Month 4 ]
  • Patients With Glycosylated Haemoglobin (HbA1c) Value < 7% [ Time Frame: Month 4 ]
  • Evolution of Fasting Plasma Glucose (FPG) [ Time Frame: From baseline to Months 4 ]
Same as current
Complete list of historical versions of study NCT01144728 on Archive Site
  • Post Prandial Plasma Glucose (PPPG) [ Time Frame: Month 4 ]
  • Number of patients for each start dose [ Time Frame: At baseline ]
  • Number of patients with different final doses [ Time Frame: Month 4 ]
  • Rate of Symptomatic Hypoglycemia [ Time Frame: During treatment period (4 months) ]
  • Change in Weight [ Time Frame: Month 4 ]
Same as current
Not Provided
Not Provided
Initiation and Titration of Amaryl
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
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Pharmaceutical form: Tablet Route of administration: oral Dose regimen : fixed dose combination of glimepiride / metformin: 1/250, 2/500
Experimental: Single arm Glimepiride+metformin
Start and titration based on FBG and tolerance. Titration should be achieved within maximum 4 weeks.
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2010
December 2010   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
35 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
U1111-1116-9956 ( Other Identifier: UTN )
Not Provided
Not Provided
Not Provided
Trial Transparency Team, sanofi-aventis
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP