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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:
Information provided by (Responsible Party):

September 3, 2015
September 7, 2015
December 14, 2017
August 1, 2015
August 31, 2017   (Final data collection date for primary outcome measure)
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 ]
Change in HbA1c, 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 ]
Complete list of historical versions of study NCT02542631 on ClinicalTrials.gov Archive Site
  • Proportion of patients with A1C ≤7.0% at week 24 [ Time Frame: 24 weeks ]
  • 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 ]
  • Change in A1C from baseline to week 44 [ Time Frame: 44 weeks ]
  • Proportion of patients with A1C ≤7.0% at week 44 [ Time Frame: 44 weeks ]
  • Change in A1C from week 24 to week 44 [ Time Frame: 44 weeks ]
  • Proportion of patients with HbA1c ≤7.0% at week 24 [ Time Frame: 24 weeks ]
  • 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 ]
  • Change in HbA1c from baseline to week 44 [ Time Frame: 44 weeks ]
  • Proportion of patients with HbA1c ≤7.0% at week 44 [ Time Frame: 44 weeks ]
  • Change in HbA1c from week 24 to week 44 [ Time Frame: 44 weeks ]
  • Treatment satisfaction and quality of life [ Time Frame: 24 weeks ]
  • Severe hypoglycemia incidence [ Time Frame: 44 weeks ]
Same as current
 
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
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
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Device: Bolus Insulin Patch (Calibra Finesse)
  • Device: Insulin Pen (Novo-Nordisk FlexPen®)
  • Experimental: Bolus Insulin Patch (Calibra Finesse)
    Use of the wearable patch to deliver meal-related bolus insulin dose
    Intervention: 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
    Intervention: Device: Insulin Pen (Novo-Nordisk FlexPen®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
August 31, 2017
August 31, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
22 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   United Kingdom,   United States
 
 
NCT02542631
VP-00525
No
Not Provided
Not Provided
Calibra Medical, Inc.
Calibra Medical, Inc.
Medpace, Inc.
Not Provided
Calibra Medical, Inc.
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP