NCT06107153

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: University of Basrah · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Despite the development of new drugs and therapeutic strategies for treating type 2 diabetes mellitus (T2DM), achieving long-term glycemic control remains a challenge. Results from the United Kingdom Prospective Diabetes Study (UKPDS) suggest that deterioration of glycemic control can be largely attributed to progressive β-cell loss, irrespective of the nature of pharmacological intervention. Therefore, treatments that can preserve or improve β-cell function are of great interest in the field of T2DM therapeutics. Some studies have shown that short-term intensive insulin therapy in patients newly diagnosed with T2DM produces beneficial effects on β-cell function, glycemic control, and rate of remission within 1 year. However, these studies applied complex regimes for insulin initiations that require frequent follow-up and are difficult to accept as initial therapy for T2DM.

Conditions

• Type2diabetes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2023-10-30
• Last updated: 2025-03-30

Locations

1 site across 1 country: Iraq

Regulatory

• FDA-regulated drug study