Type2diabetes
Conditions
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.
Interventions
DRUGInsulin 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.
DRUGSaxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg
Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg
Pioglitazone 30mg
Sponsors
University of Basrah
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c less than 7% | three months | Percentage of patients with hemoglobin A1c of less than 7% |
| Change in hemoglobin A1c | three months | mean change in hemoglobin A1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia | two weeks | Prevalence of capillary blood glucose less than 70 mg/dl by serial monitoring using home glucometer. |
Countries
Iraq
Outcome results
None listed