Insulin efficacy in diabetes management

Not Applicable

• Conditions: Diabete.; Diabetes mellitus; E10,E11,E1

• Registration Number: IRCT2013040812938N1
• Lead Sponsor: Ronak Daru Company of pharmacy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

inclusion criteria: 1-diabetic patients type 2 treated with insulin with or without oral drug. 2-100mg/dl< FBS <250mg/dl. 3-7< HbA1c< 9. 4-male or female with age > 18 years old*. 5-BMI=30 kg/m2. *We have enrolled patients with age more than 18 years, according to reference 17, 18, 19, and 20.Age don’t be considered as a confounding factor because study has randomized design.
exclusion criteria: 1- microvascular and macrovascular complications. 2-hypoglycemia(BS<45mg/dl) or hyperglycemia(BS>250mg/dl). 3-pregnancy or Breastfeeding. 4- use of glucocorticoides or any drug that lead hyperglycemia. 5- uncontrolled HTN (BP>180/105). 6-iinsulin allergy. 7-use of more than 1.4 U/kg/d insulin. 8-????? Cr>2 mg/dl or LFT>twofold normal range. 9-Patient withdrew from the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean of HbA1c in the end of study. Timepoint: HbA1c levels before and after of any intervation. Method of measurement: at before and after of intervation by laboratory with HPLC assay.

Secondary Outcome Measures

Name	Time	Method
Hypoglycemia. Timepoint: during study. Method of measurement: Bionime Glucometer.;Weight changes. Timepoint: before and after of intervation. Method of measurement: scale.;Hyperglycemia. Timepoint: during study. Method of measurement: Bionime glucometer.;Insulin dosage. Timepoint: during study. Method of measurement: unit.