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Completed

NCT Number: NCT06107153

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

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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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faiha Specialized Diabetes, Endocrine, and Metabolism Center

Basra, 61001, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin Glargine 100 UNT/ML Pen Injector [Lantus]

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.

Other names: Lantus

Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg

Drug

Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg

Other names: Kombiglyze

Pioglitazone 30mg

Drug

Pioglitazone 30mg

Other names: Actos

Primary outcomes

  1. Hemoglobin A1c less than 7%

    Time frame: three months

    Percentage of patients with hemoglobin A1c of less than 7%

  2. Hemoglobin A1c less than 7%

    Time frame: six months

    Percentage of patients with hemoglobin A1c of less than 7%

  3. Hemoglobin A1c less than 7%

    Time frame: twelve months

    Percentage of patients with hemoglobin A1c of less than 7%

  4. Change in hemoglobin A1c

    Time frame: three months

    mean change in hemoglobin A1c

  5. Change in hemoglobin A1c

    Time frame: six months

    mean change in hemoglobin A1c

  6. Change in hemoglobin A1c

    Time frame: twelve months

    mean change in hemoglobin A1c

Secondary outcomes

  1. Hypoglycemia

    Time frame: two weeks

    Prevalence of capillary blood glucose less than 70 mg/dl by serial monitoring using home glucometer.

Sponsors and collaborators

Lead sponsor

University of Basrah

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 30, 2023
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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