diabetes mellitus type II. diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention 1:Timely initiation & titration of glargine insulin (morning) due to ADA/EASD algorithm. Intervention 2: Intervention 2 : Timely initiation & titration of glargine insuli
Treatment - Drugs
Intervention 1:Timely initiation & titration of glargine insulin (morning) due to ADA/EASD algorithm
Intervention 2 : Timely initiation & titration of glargine insulin (evening )due to ADA/EASD algorithm
Sponsors
Sanofi Co.
Vice chancellor for research of Tehran university of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 149 Years
Inclusion criteria
Inclusion criteria: Male or Female = 18 years old ; A baseline HbA1c >7% but 130 mg/dL . Exclusion Criteria: Pregnant or breast feeding women ; Patients already treated with insulin other than NPH insulin; Patients treated with oral anti diabetic drugs other than metformin, SU or Pioglitazone; Patients not willing, or not able, to perform and record self-monitoring blood glucose; Patients not willing, or not able, to self-titrated insulin glargine under physician’s guidance; Patients who are not suitable for close follow up; Patients with any serious underlying illness, including hepatic failure (AST> 3 ULN), renal failure (creatinine > 1.5 mg/dl in males and > 1.4 mg/dl in females); Hospitalized patients and psychiatric disease ; Patients with history of alcohol or drug abuse ;Patients who used corticosteroids ; Patient who are involved in other clinical trials ; Known hypersensitivity to glargine insulin
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c changes. Timepoint: before usage of insulin and 6 months after usage. Method of measurement: blood test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hypoglycemia. Timepoint: any time that the attack occurred. Method of measurement: SMBG , blood test.;Change of insulin doses. Timepoint: after 45 days. Method of measurement: SMBG.;The percentage of pts achieving HbA1C < %7 at the end of 3 months period. Timepoint: before usage of insulin and 3 months after usage. Method of measurement: blood test. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Laily Najafi
Executive Manager & Assistant of Research Endocrine Research Center (Firozgar) , Institute of Endocr
Outcome results
None listed