Initiation and Titration of Amaryl | RxWiki

Initiation and Titration of Amaryl

Overview[ - collapse ][ - ]

Purpose	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
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: GLIMEPIRIDE + METFORMIN
Phase	Phase 4
Sponsor	Sanofi
Responsible Party	Sanofi
ClinicalTrials.gov Identifier	NCT01144728
First Received	June 14, 2010
Last Updated	January 28, 2011
Last verified	January 2011

Tracking Information[ + expand ][ + ]

First Received Date	June 14, 2010
Last Updated Date	January 28, 2011
Start Date	May 2010
Estimated Primary Completion Date	December 2010
Current Primary Outcome Measures	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]
Current Secondary Outcome Measures	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]

Descriptive Information[ + expand ][ + ]

Brief Title	Initiation and Titration of Amaryl
Official Title	AMIT Study - Amaryl M Initiation and Titration Study
Brief Summary	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
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: GLIMEPIRIDE + METFORMIN Pharmaceutical form: Tablet Route of administration: oral Dose regimen : fixed dose combination of glimepiride / metformin: 1/250, 2/500
Study Arm (s)	Experimental: Single arm Glimepiride+metformin Start and titration based on FBG and tolerance. Titration should be achieved within maximum 4 weeks.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	172
Estimated Completion Date	December 2010
Estimated Primary Completion Date	December 2010
Eligibility Criteria	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.
Gender	Both
Ages	35 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Kazakhstan

Administrative Information[ + expand ][ + ]

NCT Number	NCT01144728
Other Study ID Numbers	GLMET_L_04718
Has Data Monitoring Committee	Not Provided
Information Provided By	Sanofi
Study Sponsor	Sanofi
Collaborators	Not Provided
Investigators	Study Director: Clinical Sciences & Operations Sanofi
Verification Date	January 2011

Locations[ + expand ][ + ]