Status:
UNKNOWN
Metformin Therapy in Type 1 Diabetes Mellitus.
Lead Sponsor:
Poznan University of Medical Sciences
Conditions:
Loss of Control of Diabetes
Eligibility:
All Genders
18-60 years
Brief Summary
The use of exogenous insulin and incorrect nutritional habits are conducive to obesity and excess weight. This leads to the development of insulin resistance, even in patients with type 1 diabetes mel...
Eligibility Criteria
Inclusion
- age \> 18 years \<60 years,
- duration of diabetes \>3 years,
- lack of metabolic control- HbA1C\>7,5% (despite participation in 5-day WHO education program)
- treated with intensive insulin therapy
Exclusion
- metabolically decompensate diabetes with acetonuria,
- suspected lack of compliance,
- lack of glucose and ketones self-monitoring,
- hypoglycaemic unawareness or recurrent severe hypoglycemia (defined as more than two episodes of hypoglycemia lowered than 60 mg/dl with loss of consciousness, required assistance to treat) in the past 3 months,
- recurrent diabetic ketoacidosis (more than two episodes in the past year)
- another serious medical illness,
- pregnancy or sexually active woman unwilling to take birth control.
- renal impairment (estimated on the value calculated glomerular filtration rate using the MDRD formula-estimated glomerular filtration rate, eGFR\<45 mL / min
- liver cell damage Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) greater than twice the upper normal limit),
- history of drug or alcohol abuse or those who used this drug before
- changes in the way of antihypertensive and antihyperlipemic treatment.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01889706
Start Date
January 1 2009
End Date
February 1 2014
Last Update
June 28 2013
Active Locations (1)
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1
Department of Internal Medicine and Diabetology, Raszeja Hospital
Poznan, Great Poland, Poland, 60-834