- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02424500
Multi-Center Study Comparing Efficacy and Safety of Frequently Modified Insulin Therapy
Prospective, Open-Label, Randomized, Controlled, Multi-Center Study Comparing Efficacy and Safety of Frequently Modified Insulin Therapy Using Dosage Recommending Device
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The purpose of this study is to demonstrate that the use of d-Nav (d-Nav group) is superior to titration of insulin dosage relying on data from glucose meters with health care provider support (Control) in the management of insulin treated diabetes, by randomizing 200 insulin treated subjects with type 2 diabetes.
Primary Objective: To demonstrate a greater reduction in HbA1c at 6-months for d-Nav users compared to control patients in the primary cohort.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Minnesota
-
Minneapolis, Minnesota, Verenigde Staten, 55416-2699
- Park Nicollet Institute / International Diabetes Center, Minneapolis, MN
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 21 to 70 years of age
- If female, must be of non-childbearing potential or have a negative urine pregnancy test at screening and using adequate method of contraception throughout conduct of the study
- Clinical diagnosis of Type-2 diabetes for at least 1-year
- HbA1c 7.5% to 11% inclusive
Total daily dose of insulin of 25 units or more (10 units if on Lantus® alone) using one of these insulin regimens:
- Regimen 1 - a single injection of the long-acting insulin analog Lantus® (Glargine) per day (limited to a daily dose that is no more than 0.7 units per kg of body weight);
- Regimen 2 - twice daily biphasic insulin (i.e., Humalog® Mix 75/25, NovoLog® Mix 70/30) or pre-mixed insulin (i.e., Humulin® 70/30, Novolin® 70/30);
- Regimen 3 - a short-acting insulin analog (i.e., Humalog®-Lispro, NovoLog®-Aspart, Apidra®-Glulisine) before each meal and are treated with a single injection of the long-acting insulin analog Lantus® (Glargine) per day and do not utilize an insulin/carbohydrate ratio for calculating their short-acting insulin doses; or
- Regimen 4 - with a short-acting insulin analog (i.e., Humalog®-Lispro, NovoLog®-Aspart, Apidra®-Glulisine) before each meal and a single injection of the long-acting insulin analog Lantus® (Glargine) per day and utilize an insulin/carbohydrate ratio for calculating their short-acting insulin doses.
- On same insulin regimen for the previous 3-months
- May be using other diabetes agents at a stable dose for the last 3-months
- Signed and dated informed consent document, which contains HIPAA waiver information informing about all of the aspects of the clinical study;
Will regularly conduct Self-Monitored Blood Glucose. Prior to randomization must meet the following .
Minimum number of tests required from all subjects:
- Basal insulin subjects at least 4 fasting glucose readings/wk
- Premixed insulin subjects at least 8 readings/wk
- Basal-bolus insulin therapy subjects at least 16 total readings/wk
Willing and able to comply with the scheduled clinical study activities and glucose testing:
- Basal insulin subjects at least 5 fasting glucose readings/wk
- Premixed insulin subjects at least 5 pre-breakfast and 5 pre-evening meal readings/wk
- Basal-bolus insulin therapy subjects at least 20 total readings/wk which include 5 readings before each of the following time points: breakfast, lunch, evening meal and bedtime.
Note: All subjects may be asked to test during the night if clinically indicated.
- Participant must have a primary care provider
Exclusion Criteria:
- History >2 episodes of severe hypoglycemia (see definition below) in the past year, or hypoglycemic unawareness when glucose levels are ≤ 50 mg/dl;
- Significant physical, psychological, or cognitive impairment that would prohibit adherence to the protocol at the discretion of the PI;
- Splitting Lantus and taking Lantus twice a day
- Severe cardiovascular disease including a history of congestive heart failure, unstable angina, myocardial infarction or stroke within the 6-months preceding enrollment;
- Active anemia w/ hematocrit ≤ 25% in women or 30% in men;
- Advanced kidney disease Stage 4 (eGFR < 30 ml/min) and above
- Active cancer or cancer in the past 2-years (except non-melanoma skin cancer)
- History of significant liver disease including cirrhosis or elevated liver enzymes (e.g., AST and ALT greater than 3 times the upper limit of normal values).
- BMI > 45 kg/m2
- Are pregnant, plan to become pregnant during the study period, or are breastfeeding.
- Have a BGMS that cannot be downloaded.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: d-Nav Device
d-Nav Device: daily use to provide insulin dosage updates weekly - or sooner when needed based on analyzes and evaluates the historical blood glucose patterns. Insulin dosage is adjusted as required |
Insulin dosage is adjusted as required
|
Actieve vergelijker: Blood Glucose Monitoring System
Patient's personal Over the Counter Blood Glucose Monitoring System (OTC BGMS) for daily glucose testing to determine insulin dosage needed. Insulin dosage is adjusted as required |
Insulin dosage is adjusted as required
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Reduction in HbA1C
Tijdsspanne: 6 months
|
To demonstrate a greater reduction in HbA1c at 6-months for d-Nav users compared to control patients in the primary cohort.
|
6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Comparison Percent Reduction HbA1c
Tijdsspanne: 6 months
|
To determine the difference between the Control and d-Nav group in the percent of participants who achieve A1c < 7.0%, < 8.0%, and >9.0% at 6 months
|
6 months
|
Number of Glucose Readings <70 mg/dl
Tijdsspanne: 3 and 6 months
|
To determine the difference between the Control and d-Nav group in the number of glucose readings <70 mg/dl (symptomatic or asymptomatic) utilizing the documented downloaded glucose values.
|
3 and 6 months
|
Change in Rate of Hypoglycemia
Tijdsspanne: 6 months
|
To determine change (if any) in rate of hypoglycemia, during the study for d-Nav users in the secondary cohort
|
6 months
|
Comparison Percent Reduction HbA1c w/out Hypoglycemia
Tijdsspanne: 6 months
|
To determine the difference between the Control and d-Nav group in the percent of participants who achieve A1c < 7.0%, < 8.0% without a severe hypoglycemia event at 6 months.
|
6 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Richard M Bergenstal, MD, Executive Director International Diabetes Center
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PD004-1
- 5R42DK085974-03 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Diabetes mellitus, type 2
-
Diabetes Foundation, IndiaNational Diabetes Obesity and Cholesterol FoundationWervingDiabetes mellitus type 2 met complicatiesIndië
-
SanofiVoltooidDiabetes mellitus type 1 - Diabetes mellitus type 2Hongarije, Russische Federatie, Duitsland, Polen, Japan, Verenigde Staten, Finland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...Voltooid
-
PegBio Co., Ltd.WervingDiabetes mellitus type 2 (T2DM)China, Taiwan, Hongkong
-
Daewoong Pharmaceutical Co. LTD.VoltooidT2DM (diabetes mellitus type 2)Korea, republiek van
-
Cadila PharnmaceuticalsNew Millennium Indian Technology Leadership Initiative (NMITLI) program of...VoltooidOngecontroleerde diabetes mellitus type 2Indië
-
Daewoong Pharmaceutical Co. LTD.OnbekendT2DM (diabetes mellitus type 2)Korea, republiek van
-
RWTH Aachen UniversityBoehringer IngelheimVoltooidDiabetes Mellitus Type 2 (T2DM)Duitsland
-
ConjuChemBeëindigdDiabetes mellitus type 2 (T2DM)Verenigde Staten, Canada
-
Merck Sharp & Dohme LLCVoltooidDiabetes mellitus type 2 (T2DM)
Klinische onderzoeken op d-Nav
-
University of Colorado, DenverAanmelden op uitnodigingAstma bij kinderenVerenigde Staten
-
Vortant Technologies, LLCGeschorstBlindheid en slechtziendheidVerenigde Staten
-
Biosense Webster, Inc.VoltooidVentriculaire tachycardie | Paroxysmale boezemfibrilleren | Aanhoudende boezemfibrilleren | Littekengerelateerde atriale tachycardie | Prematuur ventriculair complexKroatië, Italië, Israël
-
Biosense Webster, Inc.VoltooidAritmieënTsjechische Republiek, België
-
University of California, San DiegoNational Institute of Mental Health (NIMH); Kaiser PermanenteAanmelden op uitnodigingAutisme Spectrum Stoornis | Mentale gezondheid | Implementatie Wetenschap | GedragsgezondheidVerenigde Staten
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)VoltooidStoornissen in het gebruik van middelenVerenigde Staten
-
Washington University School of MedicineUniversity of Colorado, Denver; University of California, Berkeley; University... en andere medewerkersActief, niet wervend
-
Scott Martin Miller, MDBiosense Webster, Inc.Beëindigd
-
The Hospital for Sick ChildrenCanadian Institutes of Health Research (CIHR); SickKids FoundationWervingGedragssymptomen | Suïcidale gedachten | Zelfmoord, poging tot | Zelfmoord | Zelfbeschadigend gedrag | Zelfmoord en zelfbeschadiging | ZelfmoordpreventieCanada
-
NORCE Norwegian Research Centre ASNorwegian Labour and Welfare AdministrationVoltooidDepressie | OngerustheidNoorwegen