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

NCT06107153 | Completed Phase 3 FDA Drug

• 1 other identifier: Insulin in type 2 diabetes
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type2diabetes

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Hypoglycemia

  two weeks

Study Arms (2)

basal insulin plus glucose lowering drugs

ACTIVE COMPARATOR

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]; Drug: Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg; Drug: Pioglitazone 30mg

glucose lowering drugs only

ACTIVE COMPARATOR

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; Drug: Pioglitazone 30mg

Interventions

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.

Also known as: Lantus

basal insulin plus glucose lowering drugs

Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg DRUG

Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg

Also known as: Kombiglyze

basal insulin plus glucose lowering drugs; glucose lowering drugs only

Pioglitazone 30mg DRUG

Pioglitazone 30mg

Also known as: Actos

basal insulin plus glucose lowering drugs; glucose lowering drugs only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Basrah: lead

Study Sites (1)

Faiha Specialized Diabetes, Endocrine, and Metabolism Center

Basra, 61001, Iraq

Location

Related Publications (4)

• 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.

  PMID: 18502299 BACKGROUND

• 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.

  PMID: 9283777 BACKGROUND

• 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.

  PMID: 15504992 BACKGROUND

• 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.

  PMID: 15111515 BACKGROUND

MeSH Terms

Interventions

Insulin Glargine; saxagliptin; Pioglitazone

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Haider A Alidrisi, MD

  Faiha Specialized Diabetes, Endocrine, and Metabolism Center, University of Basrah, College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

IR (1)