N/A
Completed N=278
Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Patients
Source: ClinicalTrials.gov NCT02542631 ↗Enrolled (actual)
278
Serious AEs
8.3%
Results posted
Nov 2018
Primary outcomePrimary: Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy — -1.69; -1.60 A1C % — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy |
-1.69; -1.60 | <0.0001 sig |
| SECONDARY Number of Patients With A1C ≤7.0% at Week 24 |
85; 77 | 0.26 |
| SECONDARY 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 |
26.87; 29.84 | 0.38 |
| SECONDARY Change in A1C From Baseline to Week 44 |
-1.63; -1.63 | 0.99 |
| SECONDARY Number of Patients With A1C ≤7.0% at Week 44 |
70; 68 | 0.71 |
| SECONDARY Change in A1C From Week 24 to Week 44 |
0.12; 0.07 | 0.52 |
| SECONDARY Number of Participants With Severe Hypoglycemic Event |
3; 3 | 1.00 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02542631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.