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Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Mellitus Patients Not Achieving Glycemic Targets on Basal Insulin With/Without Anti-Hyperglycemic Agents

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ClinicalTrials.gov Identifier: NCT02542631
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : December 14, 2017
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Calibra Medical, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Device: Bolus Insulin Patch (Calibra Finesse) Device: Insulin Pen (Novo-Nordisk FlexPen®) Not Applicable

Detailed Description:
Patients sub-optimally controlled on basal insulin (with/without other antihyperglycemic agents (AHAs)) will be randomized 1:1 to either Finesse or pen to initiate bolus insulin dosing and followed for a 44-week intervention period. Patients will have both basal and bolus doses of insulin adjusted throughout the trial, as is clinically indicated, based on an easy to follow insulin dosing algorithm. After the final endpoint evaluation at week 44, patients will crossover to the alternate bolus insulin delivery device for 4 weeks and complete a patient preference survey at week 48.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Mellitus Patients Not Achieving Glycemic Targets on Basal Insulin With/Without Anti-Hyperglycemic Agents
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Bolus Insulin Patch (Calibra Finesse)
Use of the wearable patch to deliver meal-related bolus insulin dose
Device: Bolus Insulin Patch (Calibra Finesse)
Active Comparator: Insulin Pen (Novo-Nordisk FlexPen®)
Use of the pen device to deliver meal-related bolus insulin dose
Device: Insulin Pen (Novo-Nordisk FlexPen®)



Primary Outcome Measures :
  1. Change in A1C, with bolus insulin dosing with Finesse versus pen, from baseline to the completion of 24 weeks of basal and bolus insulin therapy. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients with A1C ≤7.0% at week 24 [ Time Frame: 24 weeks ]
  2. Change in percent of glucose values of Continuous Glucose Monitoring (CGM) measurements within targeted range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) from baseline to week 24 (in a subset of patients) [ Time Frame: 24 weeks ]
  3. Change in A1C from baseline to week 44 [ Time Frame: 44 weeks ]
  4. Proportion of patients with A1C ≤7.0% at week 44 [ Time Frame: 44 weeks ]
  5. Change in A1C from week 24 to week 44 [ Time Frame: 44 weeks ]

Other Outcome Measures:
  1. Treatment satisfaction and quality of life [ Time Frame: 24 weeks ]
  2. Severe hypoglycemia incidence [ Time Frame: 44 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of T2DM
  • Treated with basal insulin for ≥ 6 months, with current dose stable for ≥ 6 weeks of ≥ 0.3 U/kg/day, with or without anti-hyperglycemic agents and in whom the Investigator feels advancement from basal to basal and bolus therapy is needed for the patient
  • A1C 7.5-11.0% by central lab value at screening visit
  • Already perform self-monitoring of blood glucose (SMBG) and willing to test blood glucose (BG) over the course of the study
  • Body Mass Index of ≤ 40 kg/m2

Exclusion Criteria:

  • Currently on or has been treated in the past year with insulin regimens that include bolus insulins except the need for insulins in the settings of acute illness or hospitalization
  • History of type 1 diabetes mellitus (T1DM), or diabetic ketoacidosis (DKA), or secondary forms of diabetes such as cystic fibrosis
  • Known hypersensitivity or allergy to insulin-glargine or its excipients or any other insulins
  • Two or more severe hypoglycemic episodes within the prior year
  • Hypoglycemia unawareness defined by history
  • History of proliferative diabetic retinopathy
  • Is currently unstable and/or has moderate-to-severe medical illness in the Investigator's judgment
  • Uncontrolled hypertension (either treated or untreated) defined as a systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 100 mmHg at screening
  • History of recent major surgery within 6 months, or minor surgery within 3 months (such as appendectomy) prior to screening visit, or a planned surgery during the study period
  • History of bariatric surgery
  • Active chronic infections
  • Women of child-bearing age who are pregnant, planning pregnancy, breast-feeding, or, if capable of pregnancy, are not practicing contraception if heterosexually active
  • Known hypersensitivity to plastics/polymers/adhesives
  • Known difficulties with adherence of adhesives, bandages, or dressings
  • Participated in any research study within the past 30 days
  • Currently participating in another investigational trial
  • Use of short term or chronic systemic steroids within three months of entry into the study or likelihood that same might be required during the conduct of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02542631


  Show 52 Study Locations
Sponsors and Collaborators
Calibra Medical, Inc.
Medpace, Inc.

Responsible Party: Calibra Medical, Inc.
ClinicalTrials.gov Identifier: NCT02542631     History of Changes
Other Study ID Numbers: VP-00525
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs