Faiha Specialized Diabetes, Endocrine, and Metabolism Center
Basra, 61001, Iraq
NCT Number: NCT06107153
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 3
Basra, 61001, Iraq
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(must have)
Exclusion criteria
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.
Other names: Lantus
Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg
Other names: Kombiglyze
Pioglitazone 30mg
Other names: Actos
Time frame: three months
Percentage of patients with hemoglobin A1c of less than 7%
Time frame: six months
Percentage of patients with hemoglobin A1c of less than 7%
Time frame: twelve months
Percentage of patients with hemoglobin A1c of less than 7%
Time frame: three months
mean change in hemoglobin A1c
Time frame: six months
mean change in hemoglobin A1c
Time frame: twelve months
mean change in hemoglobin A1c
Time frame: two weeks
Prevalence of capillary blood glucose less than 70 mg/dl by serial monitoring using home glucometer.
University of Basrah
Other
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