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Completed

NCT Number: NCT01144728

Initiation and Titration of Amaryl

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Almaty, Kazakhstan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GLIMEPIRIDE + METFORMIN

Drug

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

Primary outcomes

  1. Glycolysated Haemoglobin (HbA1c)

    Time frame: From baseline to Month 4

  2. Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%

    Time frame: Month 4

  3. Evolution of Fasting Plasma Glucose (FPG)

    Time frame: From baseline to Months 4

Secondary outcomes

  1. Post Prandial Plasma Glucose (PPPG)

    Time frame: Month 4

  2. Number of patients for each start dose

    Time frame: At baseline

  3. Number of patients with different final doses

    Time frame: Month 4

  4. Rate of Symptomatic Hypoglycemia

    Time frame: During treatment period (4 months)

  5. Change in Weight

    Time frame: Month 4

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

AMIT Study - Amaryl M Initiation and Titration Study

Acronym: AMIT KZ

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 16, 2010
Registry last updated
Jan 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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