CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 75 enrolled
Drug / intervention
NPH insulin +1 moredrug
Likely dose
NPH insulin 180 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03350984
NCT03350984Phase 4Completed

Insulin Scheme for Glycemic Control in Non-critical Hospitalized Patients With Type 2 Diabetes in the Context of a Health System in Mexico.

Universidad de Guanajuato·interventional·Posted Nov 22, 2017·Updated Dec 6, 2021

In Brief

A Phase 4 clinical trial evaluating NPH insulin and Glargine and Lispro insulin for Type 2 Diabetes Mellitus. Completed, enrolled 75 participants across 1 site.

Detailed Summary

The aim of the study is to determine differences in glycemic control between a basal-bolus scheme insulin and NPH scheme insulin in a population of hospitalized patients with type 2 diabetes in a Noncritical Care Facility in Mexico. Patients with a recent diagnosis of type 2 and patients on treatment with oral hypoglycaemic agents and insulin or only insulin were included. The primary outcome of the study is to determine difference in efficacy and security between a basal-bolus scheme insulin and NPH scheme insulin in patients with type 2 diabetes hospitalized in non-critical areas in a hospital in Mexico

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedNov 22, 2017
Enrollment StartNov 2, 2017
Primary CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.6 years ago

Interventions

NPH insulindrug

NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL.

Glargine and Lispro insulindrug

Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner.