Effectiveness of V-Go® for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study (2025)

Study Design

This trial was a prospective, observational, open-label, multicenter study of patients with a diagnosis of T2D and HbA1c ≥ 7% (53mmol/mol) who were switched to V-Go in 28 private practice endocrinology and internal medicine clinics across the United States. Recruitment and enrollment of patients from the clinics’ patient populations occurred over a 14-month period. The study was initiated prior to the commercial launch of V-Go with the aim of observing the effect in a real-world clinical setting of instituting V-Go therapy compared to prior treatment regimens on glycemic control, insulin dose requirements, hypoglycemia risk, weight change, and other possible adverse effects during circumstances as close to normal clinical practice as possible.

Patients were identified and recruited by participating sites if the patient met eligibility criteria and was willing to try a new insulin delivery device. After screening, enrolled patients were instructed to continue current antihyperglycemic medications and normal activities for a 4- to 6-week run-in period before V-Go was initiated. This design accounted for possible improvements in HbA1c due to clinical study effects unrelated to V-Go. Following the run-in period, baseline (month 0) HbA1c values were captured and patients were trained on how to fill, wear and appropriately use V-Go for insulin administration. Patients also received education in dosing insulin before the start of each meal, and for patients who had not used rapid acting insulin before, the immediate risk of hypoglycemia was stressed. Diet and exercise reinforcement by the investigator or other qualified person was reviewed with patients. Education pertaining to lifestyle management beyond the baseline visit was not stipulated in the protocol. Patients returned for physician visits and data collection at months 3, 6, 9 and 12 as long as they continued in the study, irrespective of whether they were treated with V-Go during the full period. Patient satisfaction surveys were conducted after 1month of V-Go initiation by phone in addition to each physician office visit. Data were recorded by the clinics and entered in a web-based electronic data capture system by the clinic staff. Sponsor monitors visited the clinics periodically to check study conduct and data. Consolidated data were subsequently reviewed to identify possible outliers for further checks before database lock. The study was observational in nature, so there were no protocol-mandated instructions to guide therapy, and forced insulin titration measures were not implemented. Aside from using V-Go within the cleared label, no limitations were imposed on concomitant therapy. Protocol procedures allowed for a 3-month supply of V-Go devices by the manufacturer, which was amended to 6months after the study was in progress to accommodate limited accessibility and coverage of V-Go by insurance providers due to the introduction of V-Go as a new product.

Patients

The inclusion and exclusion criteria were minimally restrictive given the real-world aspect to this study. Inclusion criteria to qualify for participation included: age between 21 and 80years old; diagnosed with T2D at least 12months prior; on an antihyperglycemic therapy regimen for at least a month; willing to self-monitor blood glucose at least twice a day; and HbA1c greater than or equal to 7.0% (53mmol/mol) at screening. Exclusion criteria included: acute infection with fever; serum creatinine > 265.2μmol/L (3.0mg/dL) if not on metformin, or if on metformin, serum creatinine > 123.8μmol/L (1.4mg/dL) (females) and > 132.6μmol/L (1.5mg/dL) (males) within the last 6months; pregnancy or the intention to become pregnant; any medical history of malignant melanoma or breast cancer; medical history of any cancers within the last 5years (except adequately treated basal cell carcinoma or cervical carcinoma in situ); history of alcohol or drug abuse within the last year; participation in other clinical trials involving receipt of the investigational drug within the last 30days; unwillingness or inability to comply with study procedures; requiring regular adjustments to the basal rate during a 24-h period; requiring insulin adjustments at meals of less-than 2-unit increments; or history of hypersensitivity to adhesives.

The population included patients stratified for analysis based on their prior antihyperglycemic therapy as follows: stratum 1 (S1), oral antihyperglycemic drugs (OADs) only; stratum 2 (S2), OADs + non-insulin injectable; stratum 3 (S3), once/twice-daily long-acting insulin injection ± OADs/non-insulin injectable; stratum 4 (S4), 1–3 daily premix insulin injections ± OADs/non-insulin injectable; and stratum 5 (S5), multiple daily injection (MDI) therapy with 3+ daily insulin injections ± OADs/non-insulin injectable.

Effectiveness Assessments

The primary objective was to compare the mean change in glycemic control measured by HbA1c from baseline to the end of V-Go use, and was conducted in all patients who had at least one post-baseline HbA1c on V-Go. Secondary objectives for this study included determining change in HbA1c and insulin dose from baseline at particular time points. The analyses presented here focus on 3- and 6-month data to account for limitations imposed by cost and availability constraints of the device at the time of the study. Subanalyses for efficacy based on prior antihyperglycemic therapy are focused on strata 3–5, which included a majority of the trial patients and the most natural population for this device. The HbA1c and insulin dose requirements of patients who continued treatment with V-Go compared to those who switched to other therapies but continued in the study as the comparison group were also summarized.

Safety Assessments

Safety was evaluated through analyses of hypoglycemic events and adverse events. Hypoglycemia was reported as both incidence and prevalence. Hypoglycemia was analyzed based on the following definitions: severe—an event requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions, and a confirmation from either plasma glucose ≤ 36mg/dL (2mmol/L) or prompt neurological recovery upon treatment to restore glucose to normal; documented—symptoms of hypoglycemia confirmed with a measured plasma glucose ≤ 70mg/dL (3.9mmol/L).

Patient Assessments: Treatment Satisfaction

Patients using V-Go were asked to complete treatment satisfaction surveys by phone 1month after initiating V-Go and at the start of each physician visit. Questions were answered by assigning values on a scale of 1–10 (with 1 being the worst and 10 being the best) as follows: (a) How comfortable was the V-Go? (b) How discreet was the V-Go to wear? (c) How do you feel physically? (d) How do you feel mentally? (e) How does the V-Go compare to previous therapies? Patient responses were analyzed descriptively as no baseline data were available for comparative purposes.

Statistical Analyses

All effectiveness and safety analyses were performed on the safety population consisting of all patients who were initiated on V-Go at month 0 and utilized at least one V-Go and had at least one post-product safety assessment. The primary analysis used an ANOVA model involving all patients from the safety population with at least one post-baseline HbA1c measurement, and used the least-squares mean change of HbA1c from baseline at month 0 to the last time point of V-Go use as the endpoint. The mixed model included fixed effects: strata, study site, visit, and the corresponding interactions, and the best fit within patient covariance structure was based on the Akaike criterion. A similar analysis was applied when evaluating the change from baseline based on prior antihyperglycemic therapy strata, except that therapy strata was excluded as an effect. Sites with low enrollment were combined. To compare change from baseline between patients continuing and discontinuing V-Go use, a mixed model with V-Go status and strata as fixed effects and he corresponding interaction as a covariate was employed. Safety was evaluated by analyzing hypoglycemia and adverse events. The sample size was initially planned as 33 per stratum, yielding 80% power to detect a change from baseline HbA1c of 0.5% units given a standard deviation of 1.0% units. Study enrollment differed widely across the strata, so rather than stopping enrollment in the faster-recruiting strata, the protocol was amended to allow up to 270 subjects in total, and was eventually stopped at 233. Statistical analyses were performed using SAS 9.1 or higher.

Patient Disposition and Baseline Characteristics

Two hundred thirty-three patients were screened, among whom 188 patients with T2D were enrolled in the study, with 187 patients completing the run-in period and 140 patients (74%) having at least one valid post-baseline HbA1c on V-Go for inclusion in the primary analysis. Medical history conditions reported by > 10% were hypertension (59%), hyperlipidemia (56%), coronary artery disease (26%), neuropathy (21%), arthritis (18%), gastroesophageal reflux disease (13%), and depression (12%). The patient dispositions at the 3- and 6-month time points reported here were as follows: by 3months, 153 patients (81%) continued in the study, with 141 patients on V-Go; by 6months, 133 patients (71%) remained in the study, with 111 patients on V-Go. Twelve patients were using therapies other than V-Go for glucose control at 3months, and 22 patients were doing so at 6 months. By the end of the study, 112 patients (60%) remained in the study, among whom 66 patients were on V-Go and 46 patients were using therapies other than V-Go to treat their diabetes. Major reasons for discontinuation included cost (18.1%) and adverse effects (17.6%), which were mainly hyperglycemia or skin reactions. Within the population who discontinued due to cost, the highest rates of dropout were seen between 3 and 9months, corresponding to the period when V-Go devices were no longer provided. Less than 7% of the population reported V-Go discontinuation due to user problems such as inconvenience, lack of comfort, or not liking the product.

Within the overall population, patients were stratified by their prior antihyperglycemic therapy regimens. Sample sizes were relatively small for strata 1–2, so subanalyses focused on strata 3–5: those patients using insulin prior to the study, who comprised 90% of the study population and are a natural population for this device. Within this cohort, patients on MDI (S5) made up 42% of the total population.

Demographic and baseline characteristics of the patients enrolled in the study are presented in Tables1 and ​and2.2. The age of participants ranged from 26 to 70years. The patient population enrolled in the study can be categorized as advanced patients with diabetes based on the medical conditions present and years since diagnosis. Mean HbA1c at the screening visit and at the end of the 4- to 6-week run-in period (baseline: month 0) is shown in Table2. There was a mean overall − 0.15% reduction in HbA1c from screening to the end of the run-in period. Across all patients, the mean basal dose ranged from 0 to 150 U/day and the TDD ranged from 0 to 238 U/day at baseline. In the MDI (S5) population ,the TDD ranged from 25 to 238 U/day.

Effectiveness

In the primary efficacy analysis, glycemic control, measured as the change in HbA1c, improved significantly when evaluating the change from month 0 to the last time point of V-Go use in patients (N = 140) with at least one post-baseline HbA1c measurement. The average duration of V-Go use was 278days, with a mean change in HbA1c of − 0.64% (95% CI − 0.99, − 0.30; P = 0.003).

Secondary objectives included assessing changes for particular time points, and were focused on 3- and 6-month changes. Changes in HbA1c from baseline based on continuation of V-Go use at each time point are reported in Table3 with stratification for S3, S4, and S5. After 6months of V-Go use, patients in S3 (long-acting insulin users) showed the greatest decrease from baseline in HbA1c of − 0.59% (95% CI − 0.91, − 0.26; P = 0.0005). The decreases in HbA1c from baseline were accompanied by a significant drop in TDD at both 3 and 6 months for S4 and S5 and at 3months for S3, as illustrated in Fig.1a, c. The largest decrease in TDD was seen in the MDI (S5) population, with a mean decrease in TDD of 26.6 U/day (86.8–60.2 U/day) from screening to 6months.

Patients who discontinued V-Go use were encouraged to continue with the follow-up in the study and served as a natural comparison group for patients who remained on V-Go. Comparisons of all patients (S1, S2, S3, S4, S5) who continued V-Go with those who discontinued V-Go are shown in Fig.1b and d. A significant reduction in HbA1c was observed at 6months compared to baseline, with a concurrent reduction in the TDD of insulin from 66.4 to 55.7 U/day in patients with continued V-Go use. This finding differed substantially from those who discontinued V-Go, where averages for both HbA1c and TDD were similar or higher at 6months compared to baseline values. A separate analysis was performed to compare the change from baseline HbA1c in patients from strata 3–5 with 6months of continued V-Go use (n = 99) to patients with 6months of resumed use after switching to other antihyperglycemic therapies (n = 30) to evaluate the change in HbA1c based on a similar persistence with therapy. Results from this analysis are shown in Fig.2 and demonstrate that continued V-Go use resulted in better glycemic control compared to those who discontinued V-Go to resume other therapies.

Patient Treatment Satisfaction

One hundred seventy-one patients between month 1 and the end of the study responded to questionnaires designed to gain patient perspectives on the ease, comfort, and health-related feelings associated with V-Go use. All patient surveys are included regardless of the completion of the study or the continued use of V-Go. The ratings were generally high in regards to treatment satisfaction with the use of V-Go, and are summarized in Fig.3. Patient impressions were similar to those for the overall population when stratified.

Safety

Twenty-two patients (12%) reported a hypoglycemic event (≤ 70mg/dL) while on V-Go, including one severe event at the end of 12months. All events resolved without sequelae. The rate of hypoglycemic events was low at 1.51 events per patient per year. One patient on V-Go reported a serious adverse event (SAE), hyperglycemia, that was deemed to be possibly related to V-Go. Three patients reported V-Go-related severe adverse events: two patients with skin rashes and one with hyperglycemia. Both the SAE and the severe adverse events resolved without sequelae.

Thirty-three patients (17.5%) discontinued V-Go use due to V-Go-related adverse effects. Within this group, two patients (1.1%) discontinued due to hypoglycemia; both patients had been prescribed MDI at baseline. One patient (0.5%) discontinued due to a skin infection, 11 patients (5.9%) due to skin reactions (such as redness), and 19 patients (10.1%) due to reported hyperglycemia. Discontinuations for adverse events were distributed evenly across the evaluation period.

Changes in weight were assessed for the duration of the study. Mean values of baseline weight are reported in Table2. For the patients using V-Go, the change in body weight was + 1.04kg (P = 0.0504) and + 1.63kg (P = 0.0213) at 6 and 12months, respectively. In patients discontinuing V-Go, the change in body weight was + 0.35kg (P = NS) and 0.96kg (P = NS) at 6 and 12months, respectively.

Funding

This study was sponsored by Valeritas Inc, Bridgewater, NJ, USA. Statistical interpretation, medical writing, and editorial assistance were funded by the sponsor. Open access fees are funded by the sponsor.

Conflict of Interest

All investigators’ institutions received financial support from Valeritas, Inc. to conduct the clinical trial. G.G. reports that he is a speaker for BI-Lilly, Lilly, Novo Nordisk, and Sanofi. He has also received research grant support from Medtronic and Novo Nordisk. C.R. reports no competing financial interests. B.B. has received speaker and consultant fees from AstraZeneca, BI-Lilly, Janssen, Medtronic, Novo Nordisk, and Sanofi; his employer (Atlanta Diabetes Association) has received research and grant support from Abbott, Dexcom, and Medtronic. S.A. and C.N. are employees of and stockholders in Valeritas, Inc. P.S. has received consultant fees and is a stockholder in Valeritas.com. L.S. reports no competing financial interests.

Ethical Approval

The study protocol was reviewed and approved by the New England Institutional Review Board (NEIRB) before the start of the study, and was registered in the ClinicalTrial.gov registry (identifier: NCT01326598). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

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