A Phase 3 interventional study of Insulin Glargine 100 UNT/ML Pen Injector [Lantus] and Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg in Type2diabetes, sponsored by University of Basrah. Completed at 1 site in Iraq. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by University of Basrah · Phase 3, Interventional, and Treatment
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.
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 243 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Basrah is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
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Inclusion Criteria: (must have)
Exclusion Criteria:
New diagnosed T2DM with an age of 18 years and above. HbA1c of equal to or more than 9% and or random serum glucose equal to or more than 300 mg/dl. Agree to start basal insulin for two weeks
Drug: Insulin Glargine 100 UNT/ML Pen Injector [Lantus] · Drug: Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg · Drug: Pioglitazone 30mg
New diagnosed T2DM with an age of 18 years and above. HbA1c of equal to or more than 9% and or random serum glucose equal to or more than 300 mg/dl. Refuse to start basal insulin.
Drug: Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg · Drug: Pioglitazone 30mg
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.
Also known as: Lantus
Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg
Also known as: Kombiglyze
Pioglitazone 30mg
Also known as: Actos
Hemoglobin A1c less than 7%
Percentage of patients with hemoglobin A1c of less than 7%
Time frame: three months
Hemoglobin A1c less than 7%
Percentage of patients with hemoglobin A1c of less than 7%
Time frame: six months
Hemoglobin A1c less than 7%
Percentage of patients with hemoglobin A1c of less than 7%
Time frame: twelve months
Change in hemoglobin A1c
mean change in hemoglobin A1c
Time frame: three months
Change in hemoglobin A1c
mean change in hemoglobin A1c
Time frame: six months
Change in hemoglobin A1c
mean change in hemoglobin A1c
Time frame: twelve months
Hypoglycemia
Prevalence of capillary blood glucose less than 70 mg/dl by serial monitoring using home glucometer.
Time frame: two weeks
Plan to share: Undecided — It is not yet known if there will be a plan to make IPD available.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Basrah