Effect of Short-term Basal Insulin Initiation in Newly Diagnosed Type 2 Diabetes on 1-year Glycemic Control

University of Basrah

Status and phase: Completed; Phase 3

Conditions: Type2diabetes

Treatments: Drug: Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg; Drug: Insulin Glargine 100 UNT/ML Pen Injector [Lantus]; Drug: Pioglitazone 30mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06107153

Insulin in type 2 diabetes

Details and patient eligibility

About

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.

Full 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.

Enrollment: 243 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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243 participants in 2 patient groups

basal insulin plus glucose lowering drugs

Active Comparator group

Description:

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

Treatment:

Drug: Pioglitazone 30mg

Drug: Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg

Drug: Insulin Glargine 100 UNT/ML Pen Injector [Lantus]

glucose lowering drugs only

Active Comparator group

Description:

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.

Treatment:

Drug: Pioglitazone 30mg

Drug: Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg