Clinical trial NCT06107153: Effect of Short-term Basal Insulin Initiation in Newly Diagnosed Type 2 Diabetes on 1-year Glycemic Control
Official title: Effect of Short-term Basal Insulin Initiation in Newly Diagnosed Type 2 Diabetes on 1-year Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type2diabetes
Lead sponsor: University of Basrah
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Inclusion criteria:

1. New diagnosed T2DM with an age of 18 years and above.
2. HbA1c of equal to or more than 9% and or random serum glucose equal to or more than 300 mg/dl.

The study will compare the effect of two strategies for glucose control over one year. First, two-week basal insulin and combination glucose-lowering drugs. Second, combination glucose-lowering drugs
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria: (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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hemoglobin A1c less than 7%
timeFrame: three months
measure: Hemoglobin A1c less than 7%
timeFrame: six months
measure: Hemoglobin A1c less than 7%
timeFrame: twelve months
measure: Change in hemoglobin A1c
timeFrame: three months
measure: Change in hemoglobin A1c
timeFrame: six months
measure: Change in hemoglobin A1c
timeFrame: twelve months
Secondary outcomes:
measure: Hypoglycemia
timeFrame: two weeks
Other outcomes:
Locations:
city: Basrah
country: Iraq
facility: Faiha Specialized Diabetes, Endocrine, and Metabolism Center
Study officials:
affiliation: Faiha Specialized Diabetes, Endocrine, and Metabolism Center, University of Basrah, College of Medicine
name: Haider A Alidrisi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weng J, Li Y, Xu W, Shi L, Zhang Q, Zhu D, Hu Y, Zhou Z, Yan X, Tian H, Ran X, Luo Z, Xian J, Yan L, Li F, Zeng L, Chen Y, Yang L, Yan S, Liu J, Li M, Fu Z, Cheng H. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet. 2008 May 24;371(9626):1753-60. doi: 10.1016/S0140-6736(08)60762-X.
citation: Ilkova H, Glaser B, Tunckale A, Bagriacik N, Cerasi E. Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients by transient intensive insulin treatment. Diabetes Care. 1997 Sep;20(9):1353-6. doi: 10.2337/diacare.20.9.1353.
citation: Li Y, Xu W, Liao Z, Yao B, Chen X, Huang Z, Hu G, Weng J. Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients is associated with improvement of beta-cell function. Diabetes Care. 2004 Nov;27(11):2597-602. doi: 10.2337/diacare.27.11.2597.
citation: Ryan EA, Imes S, Wallace C. Short-term intensive insulin therapy in newly diagnosed type 2 diabetes. Diabetes Care. 2004 May;27(5):1028-32. doi: 10.2337/diacare.27.5.1028.