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

Study Overview
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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.

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.

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

Conditions
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Type2diabetes

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


Participation Criteria
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Eligibility Criteria
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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: Type 1 diabetes mellitus. Recent or current steroid use Pregnancy. Glomerular filtration rate less than 60. Body mass index equal to or more than 30 kg/m2.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Inclusion criteria: 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. 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: basal insulin plus glucose lowering drugs<br>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 | Drug: Insulin Glargine 100 UNT/ML Pen Injector [Lantus]<br>* 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.<br>* Other names: Lantus;Drug: Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg<br>* Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg<br>* Other names: Kombiglyze;Drug: Pioglitazone 30mg<br>* Pioglitazone 30mg<br>* Other names: Actos;|
| Active Comparator: glucose lowering drugs only<br>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. | Drug: Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg<br>* Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg<br>* Other names: Kombiglyze;Drug: Pioglitazone 30mg<br>* Pioglitazone 30mg<br>* Other names: Actos;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c less than 7% | Percentage of patients with hemoglobin A1c of less than 7% | three months | 
| Hemoglobin A1c less than 7% | Percentage of patients with hemoglobin A1c of less than 7% | six months | 
| Hemoglobin A1c less than 7% | Percentage of patients with hemoglobin A1c of less than 7% | twelve months | 
| Change in hemoglobin A1c | mean change in hemoglobin A1c | three months | 
| Change in hemoglobin A1c | mean change in hemoglobin A1c | six months | 
| Change in hemoglobin A1c | mean change in hemoglobin A1c | twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia | Prevalence of capillary blood glucose less than 70 mg/dl by serial monitoring using home glucometer. | two weeks |