PH Insulin efficacy in diabetes management

Not Applicable

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

• Registration Number: IRCT2013040912938N2
• 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: 196

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<70mg/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- insulin 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. Timepoint: before and after of study. Method of measurement: HPLC assay.

Secondary Outcome Measures

Name	Time	Method
Dosage of insulin. Timepoint: before and after of study. Method of measurement: unit.;Hyperglycemia. Timepoint: during study. Method of measurement: with laburatory or SMBG.;Hypoglycemia. Timepoint: during study. Method of measurement: with laburatory or SMBG.;Weight change. Timepoint: before and afterof study. Method of measurement: scale.