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.

Study Overview

• Status: Completed
• Conditions: Type2diabetes
• Intervention / Treatment: Drug: Insulin Glargine 100 UNT/ML Pen Injector [Lantus]; Drug: Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg; Drug: Pioglitazone 30mg

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.

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iraq
  • Basrah, Iraq, 61001
    • Faiha Specialized Diabetes, Endocrine, and Metabolism Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: 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.; Other Names: Lantus; Drug: Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg; Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg; Other Names: Kombiglyze; Drug: Pioglitazone 30mg; Pioglitazone 30mg; Other Names: Actos
Active Comparator: 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.	Drug: Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg; Saxagliptin 2.5 mg/ Metformin Hydrochloride extended release 1000 mg; Other Names: Kombiglyze; Drug: Pioglitazone 30mg; Pioglitazone 30mg; Other Names: Actos

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Basrah
• Investigators: Principal Investigator: Haider A Alidrisi, MD, Faiha Specialized Diabetes, Endocrine, and Metabolism Center, University of Basrah, College of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Enzyme Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Insulin Glargine; Pioglitazone; Metformin; Saxagliptin
• Other Study ID Numbers: Insulin in type 2 diabetes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes