Initiation and Titration of Amaryl

Diabetes Mellitus, Type 2 Clinical Trial

— AMIT KZ  

Official title:

AMIT Study - Amaryl M Initiation and Titration Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144728
• Other study ID #: GLMET_L_04718
• Secondary ID: U1111-1116-9956
• Status: Completed
• Phase: Phase 4
• First received: June 14, 2010
• Last updated: January 28, 2011
• Start date: May 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kazakhstan: Ethical Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
Kazakhstan	Sanofi-Aventis Administrative Office	Almaty

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycolysated Haemoglobin (HbA1c)		From baseline to Month 4	No
Primary	Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%		Month 4	No
Primary	Evolution of Fasting Plasma Glucose (FPG)		From baseline to Months 4	No
Secondary	Post Prandial Plasma Glucose (PPPG)		Month 4	No
Secondary	Number of patients for each start dose		At baseline	No
Secondary	Number of patients with different final doses		Month 4	No
Secondary	Rate of Symptomatic Hypoglycemia		During treatment period (4 months)	Yes
Secondary	Change in Weight		Month 4	No