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Initiation and Titration of Amaryl (AMIT KZ)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01144728
First received: June 14, 2010
Last updated: January 28, 2011
Last verified: January 2011
History of Changes

June 14, 2010
January 28, 2011
May 2010
December 2010   (final data collection date for primary outcome measure)
  • Glycolysated Haemoglobin (HbA1c) [ Time Frame: From baseline to Month 4 ] [ Designated as safety issue: No ]
  • Patients With Glycosylated Haemoglobin (HbA1c) Value < 7% [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
  • Evolution of Fasting Plasma Glucose (FPG) [ Time Frame: From baseline to Months 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01144728 on ClinicalTrials.gov Archive Site
  • Post Prandial Plasma Glucose (PPPG) [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
  • Number of patients for each start dose [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Number of patients with different final doses [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
  • Rate of Symptomatic Hypoglycemia [ Time Frame: During treatment period (4 months) ] [ Designated as safety issue: Yes ]
  • Change in Weight [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
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
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: GLIMEPIRIDE + METFORMIN
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.
Intervention: Drug: GLIMEPIRIDE + METFORMIN
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
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.
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Kazakhstan
 
NCT01144728
GLMET_L_04718, U1111-1116-9956
Not Provided
Trial Transparency Team, sanofi-aventis
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
January 2011

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