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

NCT06107153 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

  • Type2diabetes

Interventions

DRUG

Insulin Glargine 100 UNT/ML Pen Injector [Lantus]

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.

DRUG

Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg

Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg

DRUG

Pioglitazone 30mg

Pioglitazone 30mg

Sponsors & Collaborators

  • University of Basrah

    lead OTHER

Principal Investigators

  • Haider A Alidrisi, MD · Faiha Specialized Diabetes, Endocrine, and Metabolism Center, University of Basrah, College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-11-01
Completion
2024-11-01
FDA Drug
Yes

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06107153 on ClinicalTrials.gov