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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
  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 Intervention Phase
Diabetes Mellitus, Type 2
 Drug: GLIMEPIRIDE + METFORMIN
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AMIT Study - Amaryl M Initiation and Titration Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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 ]

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 ]

Enrollment: 172
Study Start Date: May 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm Glimepiride+metformin
Start and titration based on FBG and tolerance. Titration should be achieved within maximum 4 weeks.
 Drug: GLIMEPIRIDE + METFORMIN
Pharmaceutical form: Tablet Route of administration: oral Dose regimen : fixed dose combination of glimepiride / metformin: 1/250, 2/500

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144728

Locations
Kazakhstan
Sanofi-Aventis Administrative Office
Almaty, Kazakhstan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT01144728     History of Changes
Other Study ID Numbers: GLMET_L_04718, U1111-1116-9956
Study First Received: June 14, 2010
Last Updated: January 28, 2011
Health Authority: Kazakhstan: Ethical Commission

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013