Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D

NCT04538352 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20-853
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine whether therapy with once-weekly sc semaglutide in combination with once-daily insulin degludec will be capable of maintaining (or improving) glycemic control, when substituted for multiple daily injections of insulin (MDI), in patients with T2D with adequate glycemic control (≤ 7.5%) on MDI-based regimens (≤ 80 units of insulin per day), vs. further titration of insulin therapy in those continuing MDI. Weight loss, hypoglycemic episodes, and improvement in diabetes-treatment satisfaction will also be assessed between the two groups.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean Change in HbA1C ≤ 7.5%

  Mean change in HbA1C ≤ 7.5% from baseline to 26 weeks between the two groups

  26 weeks

Secondary Outcomes (5)

• Mean Weight Change

  26 weeks

• Hypoglycemic Episodes

  26 weeks

• Mean Change From Baseline in A1C

  26 weeks

• Diabetes Treatment Satisfaction Comparison Between Groups

  26 weeks

• Total Daily Insulin Dose

  26 weeks

Study Arms (2)

Once-weekly sc semaglutide combined with once-daily insulin

EXPERIMENTAL

Patients randomized to continue with MDI will be transitioned from their existing regimen to the rapid-acting insulin product insulin aspart and their basal insulin switched to once-daily insulin degludec.

Drug: Semaglutide; Drug: Insulin Degludec; Drug: Insulin aspart

MDI requiring multiple daily injections of insulin

EXPERIMENTAL

Patients randomized to MDI will be allowed to continue correction rapid-acting insulin, in addition to their prandial doses of rapid-acting insulin, throughout the duration of the study.

Drug: Insulin Degludec; Drug: Insulin aspart

Interventions

Semaglutide DRUG

Medication for type 2 diabetes management

Also known as: Ozempic

Once-weekly sc semaglutide combined with once-daily insulin

Insulin Degludec DRUG

Medication for type 2 diabetes management

Also known as: Tresiba

MDI requiring multiple daily injections of insulin; Once-weekly sc semaglutide combined with once-daily insulin

Insulin aspart DRUG

Medication for type 2 diabetes management (rapid-acting)

Also known as: Novolog

MDI requiring multiple daily injections of insulin; Once-weekly sc semaglutide combined with once-daily insulin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gender: men and women
• Ethnicity: all ethnic groups
• Language: English
• Age: ≥ 18 to 75 years
• Type II diabetes
• Currently treated with MDI (basal/bolus regimen) for at least 6 months
• MDI must consist of three or more injections of insulin per day, with at least 2 injections being prandial/rapid-acting insulin
• Prandial insulin restricted to insulin aspart, glulisine, and lispro
• Basal insulin restricted to long acting once-daily analogues (insulin glargine U- 100, insulin degludec (U-100 or U-200), or insulin glargine U-300)
• A1C within 30 days of randomization must be ≤ 7.5% on the present therapy
• Less than or equal to 120 units of total insulin therapy per day
• Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject.

You may not qualify if:

• GAD-65 antibody positive
• Current glucocorticoid therapy greater than 5 mg of daily prednisone (or equivalent dose of other glucocorticoid)
• Known or suspected allergy to trial medication(s), excipients, or related products, i.e., GLP-1RA therapy or insulin aspart or insulin degludec.
• The receipt of any investigational drug within 90 days prior to this trial.
• Previous participation in this trial (Randomized)
• Mental incapacity or language barrier (non-English speaking)
• DPP-4 inhibitors sitagliptin, saxagliptin, linagliptin, alogliptin
• GLP-1RA (exenatide, liraglutide, exenatide LAR, dulaglutide, albiglutide, lixisenatide, semaglutide)
• GLP-1RA/Basal Insulin combination (IGlarLixi, IDegLira)
• Present use of oral anti-diabetic agents other than metformin and SGLT-2i. The dose of metformin and/or SGLT-2i must be unchanged and stable for the immediate 3 months prior to baseline.
• Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
• Personal or family history of medullary thyroid carcinoma
• Personal or family history of Multiple Endocrine Neoplasia syndrome type 2
• History of acute or chronic pancreatitis, severe liver disease or LFT's \> 2.5X ULN, or severe disease of digestive tract
• History of bariatric surgery/procedure (gastric banding, gastric sleeve, or Roux-en-Y)

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Rodriguez P, Breslaw N, Xiao H, Bena J, Jenkins K, Isaacs D, Zhou K, Griebeler ML, Burguera B, Pantalone KM; TRANSITION-T2D Investigators. De-intensification of basal-bolus therapy by replacing prandial insulin with once-weekly subcutaneous semaglutide in individuals with well-controlled type 2 diabetes: A single-centre, open-label randomised trial (TRANSITION-T2D). Diabetes Obes Metab. 2025 Feb;27(2):642-651. doi: 10.1111/dom.16057. Epub 2024 Nov 12.

  PMID: 39532398 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide; insulin degludec; Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Research Administrator
• Organization: The Cleveland Clinic Foundation

jenkink@ccf.org

(216) 445-4791

Study Officials

• Kevin Pantalone, DO

  Staff

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 4, 2020
• Study Start: January 18, 2021
• Primary Completion: March 31, 2023
• Study Completion: November 1, 2023
• Last Updated: February 18, 2025
• Results First Posted: July 29, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)