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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glimepiride
Metformin
Anti-Arrhythmia Agents
Cardiovascular Agents
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014