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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type2diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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basal insulin plus glucose lowering drugs

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

Group Type ACTIVE_COMPARATOR

Insulin Glargine 100 UNT/ML Pen Injector [Lantus]

Intervention Type DRUG

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.

Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg

Intervention Type DRUG

Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg

Pioglitazone 30mg

Intervention Type DRUG

Pioglitazone 30mg

glucose lowering drugs only

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.

Group Type ACTIVE_COMPARATOR

Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg

Intervention Type DRUG

Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg

Pioglitazone 30mg

Intervention Type DRUG

Pioglitazone 30mg

Interventions

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Insulin 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.

Intervention Type DRUG

Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg

Intervention Type DRUG

Pioglitazone 30mg

Intervention Type DRUG

Other Intervention Names

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Lantus Kombiglyze Actos

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No