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AzTrials

Type2diabetesPhase 3NCT06107153

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

A Phase 3 study testing Insulin Glargine 100 UNT/ML Pen Injector [Lantus], Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg and Pioglitazone 30mg in people with Type2diabetes, run by University of Basrah at 1 site in Iraq.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type2diabetes
What is being tested?
Insulin Glargine 100 UNT/ML Pen Injector [Lantus], Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg and Pioglitazone 30mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
243 participants
Where
1 siteIraq
Study dates
1 Nov 2023to 1 Nov 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Iraq1 site

  • Faiha Specialized Diabetes, Endocrine, and Metabolism Center

    Basra, 61001

Other trials in Iraq

About this study

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.

Read the 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.

Conditions
Type2diabetes
Being tested
Insulin Glargine 100 UNT/ML Pen Injector [Lantus], Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg, Pioglitazone 30mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called 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.

  • Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mgDrug

    Also called Kombiglyze

    Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg

  • Pioglitazone 30mgDrug

    Also called Actos

    Pioglitazone 30mg

Study groups in NCT06107153
Study groupRoleWhat they receive
basal insulin plus glucose lowering drugsActive comparatorNew 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
Receives: Drug: Insulin Glargine 100 UNT/ML Pen Injector [Lantus]; Drug: Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg; Drug: Pioglitazone 30mg
glucose lowering drugs onlyActive comparatorNew 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.
Receives: Drug: Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg; Drug: Pioglitazone 30mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin A1c less than 7%

    Percentage of patients with hemoglobin A1c of less than 7%

    Measured: three months

  2. Hemoglobin A1c less than 7%

    Percentage of patients with hemoglobin A1c of less than 7%

    Measured: six months

  3. Hemoglobin A1c less than 7%

    Percentage of patients with hemoglobin A1c of less than 7%

    Measured: twelve months

  4. Change in hemoglobin A1c

    mean change in hemoglobin A1c

    Measured: three months

  5. Change in hemoglobin A1c

    mean change in hemoglobin A1c

    Measured: six months

  6. Change in hemoglobin A1c

    mean change in hemoglobin A1c

    Measured: twelve months

Secondary outcomes (1)

  1. Hypoglycemia

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

    Measured: two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start1 Nov 2023
  3. Primary completion1 Nov 2024
  4. Study completion1 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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
Masking
None (open label)
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06107153
Sponsor's protocol ID
Insulin in type 2 diabetes
Status last verified
Mar 2025
First submitted
24 Oct 2023
Last updated
30 Mar 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: It is not yet known if there will be a plan to make IPD available.

Publications

  • Weng J, Li Y, Xu W, Shi L, Zhang Q, Zhu D, Hu Y, Zhou Z, Yan X, Tian H, Ran X, Luo Z, Xian J, Yan L, Li F, Zeng L, Chen Y, Yang L, Yan S, Liu J, Li M, Fu Z, Cheng H. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet. 2008 May 24;371(9626):1753-60. doi: 10.1016/S0140-6736(08)60762-X.

    PubMed 18502299

  • Ilkova H, Glaser B, Tunckale A, Bagriacik N, Cerasi E. Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients by transient intensive insulin treatment. Diabetes Care. 1997 Sep;20(9):1353-6. doi: 10.2337/diacare.20.9.1353.

    PubMed 9283777

  • Li Y, Xu W, Liao Z, Yao B, Chen X, Huang Z, Hu G, Weng J. Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients is associated with improvement of beta-cell function. Diabetes Care. 2004 Nov;27(11):2597-602. doi: 10.2337/diacare.27.11.2597.

    PubMed 15504992

  • Ryan EA, Imes S, Wallace C. Short-term intensive insulin therapy in newly diagnosed type 2 diabetes. Diabetes Care. 2004 May;27(5):1028-32. doi: 10.2337/diacare.27.5.1028.

    PubMed 15111515

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin Glargine 100 UNT/ML Pen Injector [Lantus], Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg and Pioglitazone 30mg in people with Type2diabetes, run by University of Basrah at 1 site in Iraq.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin A1c less than 7% (time frame: three months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06107153, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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