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Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Patients

NCT02542631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2025-02-04

Study results available
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Summary

To compare glycemic control and treatment satisfaction using a novel bolus insulin patch (Finesse) versus a pen for initiating and managing bolus insulin dosing in patients with T2DM not achieving glycemic targets on basal insulin with/without anti-hyperglycemic agents.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DEVICE

Bolus Insulin Patch (Calibra Finesse)

DEVICE

Insulin Pen (Novo-Nordisk FlexPen®)

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Calibra Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard M Bergenstal, MD · International Diabetes Center at Park Nicollet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-01
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United States
  • France
  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02542631 on ClinicalTrials.gov