CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 243 enrolled
Drug / intervention
Insulin Glargine 100 UNT/ML Pen Injector [Lantus] +2 moredrug
Likely dose
Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 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/NCT06107153
NCT06107153Phase 3Completed

Effect of Short-term Basal Insulin Initiation in Newly Diagnosed Type 2 Diabetes on 1-year Glycemic Control

University of Basrah·interventional·Posted Oct 30, 2023·Updated Mar 30, 2025

In Brief

A Phase 3 clinical trial evaluating Insulin Glargine 100 UNT/ML Pen Injector [Lantus], Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg, and 1 other intervention for Type2diabetes. Completed, enrolled 243 participants across 1 site.

Detailed Summary

In this study, we aim to explore the beneficial effect of early short-term (two weeks), self-titrated, basal-only insulin therapy on the degree of glycemic control over 1-year follow through a prospective cohort.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType2diabetes
CountriesIraq
Collaborators--

Timeline

Phase 3CompletedFinished
202420252026
First PostedOct 30, 2023
Enrollment StartNov 1, 2023
Primary CompletionNov 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 2.7 years ago

Interventions

Insulin Glargine 100 UNT/ML Pen Injector [Lantus]drug

Insulin is given as glargine U100 at bedtime in a dose of 10 units. The patients will be given instruction to up-titrate the insulin by adding two units every two days with an aim to reach fasting blood glucose (FBG) between 80 - 130 mg/dl using a home glucometer. And to down-titrate the insulin by subtracting two units when the FBG is below 80 mg/dl. The patients continued on basal insulin for two weeks or less when FBG is persistently below 100 mg/dl on a dose of 10 units of insulin Glargine.

Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mgdrug

Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg

Pioglitazone 30mgdrug

Pioglitazone 30mg