Initiation and Titration of Amaryl

AMIT Study - Amaryl M Initiation and Titration Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01144728

Acronym

AMIT KZ

Enrollment

172

Registered

2010-06-16

Start date

2010-05-31

Completion date

2010-12-31

Last updated

2011-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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

Interventions

DRUGGLIMEPIRIDE + METFORMIN

Pharmaceutical form: Tablet Route of administration: oral Dose regimen : fixed dose combination of glimepiride / metformin: 1/250, 2/500

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Kazakhstan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026