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NPH Insulin efficacy in diabetes management

Comparison of efficacy of moderater-acting insulin (NPH) manufactured by Ronak Daru (Ronulin ®) with manufactured by Exir (Lansulin®) in reducing fasting blood sugar in patients with type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013040912938N2
Enrollment
196
Registered
2013-05-01
Start date
2012-12-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabete. Diabetes mellitus

Interventions

Intervention 1: Intervention:NPH manufactured by Ronak Daru (Ronulin ®) through FBS=90-130 mg and HbA1c<7 during 3 months. Intervention 2: control: NPH manufactured by Exir (Lansulin®) through target
Treatment - Drugs
Intervention:NPH manufactured by Ronak Daru (Ronulin ®) through FBS=90-130 mg and HbA1c<7 during 3 months.
control: NPH manufactured by Exir (Lansulin®) through target FBS= 90-130 mg/dl and HbA1c<7 during 3 months.

Sponsors

Ronak Daru Company of pharmacy
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: inclusion criteria:1- diabetic patients type 2 treated with insulin with or without oral drug. 2-100mg/dl 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(BS250mg/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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mean of HbA1c. Timepoint: before and after of study. Method of measurement: HPLC assay.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr yues Panahi

chemical injery research center

yunespanahi@yahoo.com+98 21 8821 1524

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026