Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose

NCT04623086 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00008108
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates direct switching vs use of a bridging dose from insulin glargine to insulin degludec in type 1 DM patients. Half of the participants will receive a bridging insulin glargine dose along with the 1st dose of degludec, while other half will receive a placebo and 1st dose of degludec.

Conditions

Type 1 Diabetes

Keywords

Insulin glargine, insulin degludec

Outcome Measures

Primary Outcomes (1)

• Mean Change in Percent Time in Range

  Change in percent time spent in target glycemic range (TIR, glucose 70-180 mg/dL, both values included) in the 48 hours before and the 48 hours after the 1st dose of IDeg.

  48 hours prior to 48 hours after 1st dose of degludec insulin

Secondary Outcomes (7)

• Coefficient of Variation (CV) of Percent-time-in-range

  48 hours prior to 48 hours after 1st dose of degludec insulin

• Nocturnal Percent Time in Range of 70-180 mg/dL Nocturnal Time in Range (N-TIR)

  4 days: Outcome Measure Time Frame 48 hours prior to 48 hours after 1st dose of degludec insulin

• Percent Time Above 180 mg/dL (TAR-1)

  4 days

• Time Above Range-2 (TAR-2)

  4 days

• Time Below Range-1 (TBR-1)

  48 hours prior to 48 hours after 1st dose of degludec insulin

Study Arms (2)

Insulin Glargine and Insulin Degludec

EXPERIMENTAL

Insulin glargine, 100 units per mL injected subcutaneously daily Insulin Degludec, 100 units per mL injected subcutaneously daily

Drug: Insulin Degludec; Drug: Insulin Glargine

Insulin Degludec and placebo

PLACEBO COMPARATOR

Insulin Degludec, 100 units per mL injected subcutaneously daily Placebo, 9g/L sodium chloride (normal saline) injected subcutaneously daily

Drug: Insulin Degludec; Drug: Placebo

Interventions

Insulin Degludec DRUG

Insulin Degludec injection

Also known as: Tresiba

Insulin Degludec and placebo; Insulin Glargine and Insulin Degludec

Insulin Glargine DRUG

Insulin Glargine injection

Also known as: Lantus

Insulin Glargine and Insulin Degludec

Placebo DRUG

9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection

Insulin Degludec and placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age is 18-75 years.
• Diagnosis of T1D of at least 1-year duration.
• Has the ability to provide informed consent before any trial-related activities.
• Treated with insulin glargine as their basal insulin in the 3 months preceding screening visit.
• Stable insulin regimen (defined as change of \<20% in the total daily dose of insulin and no change to the basal insulin agent) over the 3 months preceding the screening visit.
• Patient willing to dose their basal insulin at bedtime.
• Hemoglobin A1c \< 9% in the 3 months preceding screening visit.
• Able to self-administer their insulin doses.
• Able to do self-monitoring of blood glucose using a glucose meter and willing to do this at least 2 times daily for patients using a CGM that requires calibration prior to the study and 4 times daily for patients who were not using a CGM prior to the study.
• Agreeable to the use of a continuous glucose monitor (CGM) for the duration required in the study. If already using a CGM prior to the study, then agreeable to wearing the blinded study CGM concurrently during the study period.
• Will be reachable by phone and/or email to comply with study procedures.
• Will be able to comply with study procedures, per investigator's opinion.
• Patient agrees to not use correctional insulin unless BG ≥250 for the 48 hours before and after 1st dose of IDeg.

You may not qualify if:

• Patients with eGFR \<30 on at least 2 measurements within 1-year of the screening visit.
• History of myocardial infarction within 6 months preceding the screening visit.
• Patients taking non-insulin medications for the glycemic management of T1D (including metformin, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 inhibitors, thiazolidinediones, alpha-glucosidase inhibitors, pramlintide)
• Known or suspected allergy to IDeg or one of its excipients.
• Pregnant, planning to become pregnant in the next 3 months or breastfeeding.
• Participation in a clinical trial with investigational drug within 1 month of the screening visit or at present.
• Skin condition that prevents the insertion of the CGM.
• Previously randomized and received drug in this study.
• Presence of decompensated or poorly controlled psychiatric conditions.
• Current known or suspected illicit substance use.
• Any anticipated surgery or procedure in the next 14 days.
• Patients using U-300 glargine as their basal insulin.
• Patients using insulin afrezza as their short-acting insulin.
• Use of glucocorticoid burst/pulse therapy within 14 days prior to screening visit (chronic stable glucocorticoid doses are acceptable).

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Medicine Diabetes Institute at South Lake Union

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin degludec; Insulin Glargine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Arthi Thirumalai
• Organization: University of Washington

arthidoc@uw.edu

206-221-0521

Study Officials

• Arthi Thirumalai, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine: Metabolism, Endocrinology and Nutrition

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 10, 2020
• Study Start: February 14, 2020
• Primary Completion: September 7, 2022
• Study Completion: December 31, 2023
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-02

Locations

US (1)