Effect of Short-term Basal Insulin Initiation in Newly Diagnosed Type 2 Diabetes on 1-year Glycemic Control
- Conditions
- Type2diabetes
- Interventions
- Drug: Insulin Glargine 100 UNT/ML Pen Injector [Lantus]
- Registration Number
- NCT06107153
- Lead Sponsor
- University of Basrah
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 243
(must have)
- Newly diagnosed type 2 diabetes mellitus on no glucose-lowering drugs and
- Either hemoglobin A1c equal to or more than 9% and/or random blood glucose equal to or more than 300 mg/dl.
- Patients with type 1 diabetes mellitus,
- Urine ketone dipstick + and above at baseline or anytime throughout the study.
- Pregnancy.
- Current or recent steroid use.
- History of coronary heart disease and heart failure.
- GFR less than 60 mL/min/1.73 m2.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description glucose lowering drugs only 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. glucose lowering drugs only Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg 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. basal insulin plus glucose lowering drugs Insulin Glargine 100 UNT/ML Pen Injector [Lantus] 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 basal insulin plus glucose lowering drugs Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg 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 basal insulin plus glucose lowering drugs 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. Agree to start basal insulin for two weeks
- Primary Outcome Measures
Name Time Method Hemoglobin A1c less than 7% twelve months Percentage of patients with hemoglobin A1c of less than 7%
Change in hemoglobin A1c twelve months mean change in hemoglobin A1c
- Secondary Outcome Measures
Name Time Method Hypoglycemia two weeks Prevalence of capillary blood glucose less than 70 mg/dl by serial monitoring using home glucometer.
Trial Locations
- Locations (1)
Faiha Specialized Diabetes, Endocrine, and Metabolism Center
🇮🇶Basrah, Iraq