Trials Sponsors Conditions Drugs Pricing

Conditions

Type 2 Diabetes Type 2 Diabetes Mellitus

Keywords

VGoInsulinType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Non-inferiority Hypothesis.
Per protocol population for assessment of non-inferiority of RHI. Week 12 change from baseline in HbA1c comparison of RHI versus RAI estimated treatment difference.
Baseline and Week 12

Secondary Outcomes (6)

Evaluate the Prevalence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.
Baseline and Week 12
Evaluate the Incidence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.
Baseline and Week 12
Evaluate the Change in Total Daily Doses (Units/kg) of Insulin Between Groups After 12 Weeks of Treatment.
Baseline and Week 12
Evaluate the Change in Total Daily Doses (TDD), Units/Day of Insulin Between Groups After 12 Weeks of Treatment.
Baseline and Week 12
Evaluate the Difference in Direct Pharmacy Insulin Costs to Insurance Payor Using Wholesale Acquisition Costs Between Groups.
Baseline and Week 12
+1 more secondary outcomes

Other Outcomes (1)

Evaluate the Change in Glucose Patterns Between Groups Based on 7-point Glucose Profiles.
Baseline and Week 12

Study Arms (2)

VGo with Regular Human Insulin

EXPERIMENTAL

U-100 short-acting insulin, Regular, human insulin rDNA origin, including Humulin® R, Novolin® R, and ReliOn (Novolin R) delivered by V-Go

Device: VGo

VGo with Rapid Acting Insulin

ACTIVE COMPARATOR

U-100 fast-acting insulin including Humalog® (insulin lispro, rDNA origin) or NovoLog® (insulin aspart, rDNA origin), which have both been tested by Valeritas, Inc. and found to be safe for use in the V-Go or Apidra® (insulin glulisine, rDNA origin) delivered by V-Go

Device: VGo

Interventions

VGoDevice

Eligible subjects will be randomized to either stay on RAI delivered by V-Go or randomized to switch to U-100 RHI delivered by V-Go.

VGo with Rapid Acting InsulinVGo with Regular Human Insulin

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 21 years at time of study enrollment
Diagnosed with T2D for at least 6 months prior to screening

Sponsors & Collaborators

Dallas Diabetes Research
Othercollaborator
Valeritas, Inc.
Industrycollaborator
East Coast Institute for Research

Study Sites (2)

East Coast Institute for Research, LLC

Jacksonville, Florida, 32204, United States

East Coast Institute for Research, LLC

Macon, Georgia, 31210, United States

Related Publications (1)

Mora PF, Sutton DR, Gore A, Baliga B, Goldfaden RF, Nikkel C, Sink Ii J, Adams-Huet B. Efficacy, safety and cost-effectiveness comparison between U-100 human regular insulin and rapid acting insulin when delivered by V-Go wearable insulin delivery device in type 2 diabetes. BMJ Open Diabetes Res Care. 2020 Nov;8(2):e001832. doi: 10.1136/bmjdrc-2020-001832.
PMID: 33214190DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Results Point of Contact

Title: Dr Pablo F Mora
Organization: The University of Texas Southwestern Medical Center

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

136 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: NETWORK
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 17, 2018

First Posted

April 12, 2018

Study Start

April 9, 2018

Actual (reported)

Regular Insulin vs Rapid Insulin Delivered by V-Go

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Other Outcomes (1)

Study Arms (2)

VGo with Regular Human Insulin

VGo with Rapid Acting Insulin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Other Outcomes (1)

Study Arms (2)

VGo with Regular Human Insulin

VGo with Rapid Acting Insulin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations