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Trial: NCT02846233 [RDF]

Label NCT02846233
Slug nct02846233
Trialid NCT02846233
Lookup name NCT02846233
Provenance http://clinicaltrials.gov/show/NCT02846233?displayxml=true
Lastchanged date August 1, 2016
Firstreceived results date
Firstreceived date July 19, 2016
Id info nct id NCT02846233
Overall status Not yet recruiting
Id info secondary id
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 40
Number of arms 2
Is section 801
Is fda regulated No
Brief title Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?
Acronym
Official title Is the Stepping-down Approach a Better Option Than Multiple Daily Injections in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?
Study type Interventional
Id info nct alias
Completion date August 2018
Verification date August 2016
Why stopped
Id info org study id RDMSTEP
Required header url https://clinicaltrials.gov/show/NCT02846233
Study design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Source University of California, San Francisco
Primary completion date February 2018
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on September 06, 2016
Phase N/A
Start date August 2016
Has expanded access No
Biospec descr
Detailed description A prospective, randomized, open-label, controlled, parallel-group trial is planned. This study is an interdepartmental collaborative study among the Department of Internal Medicine, Department of Family & Community Medicine (UCSF Fresno), Sierra Vista Family Medicine Residency Program and Division of Endocrinology. The study will be conducted at the following multiple locations in order to maximize the patient recruitment: 1. Internal medicine clinic at Derian Koligian ambulatory care center (ACC) 2. Family practice medicine clinic at ACC 3. Diabetes clinic at ACC 4. Internal medicine clinic at University Medicine Associates in East medical Plaza 5. Endocrine clinic at University Medicine Associates in East medical Plaza 6. Sierra Vista clinics The patients will be recruited during the first 12 months of the study or until the predetermined sample size is reached, whichever comes first. The patient's primary care provider will be informed of the enrollment in the study if the participant gives the permission to do so. All participants in both group will need to make all 3 visits to UCSF Clinical Research Center over 16- week period. (1) First visit: Once the site co-investigators identify the suitable and interested study patient, a trained research coordinator will contact the patient for the first visit. The patient will be seen at the UCSF Clinical Research Center by the research coordinator and a physician co-investigator. During the first visit, all patients in both group will - be given the information about the study. - sign the consent form. - be randomly assigned to either treatment (i.e. Step Down) or control (MDI) group by using A Randomization Plan from http://www.randomization.com. - have the blood test for A1c, CMP, CBC, fasting lipid and measurements of body weight, height, blood pressure, and heart rate. - complete both the Diabetes Medications Satisfaction (DM-SAT) Questionnaire form and the modified Morisky Medication Adherence Scale. Medication changes at first visit: In treatment group, 1. All prandial insulin injections (Humalog, Novolog, Apidra, Novolin R or Humulin R), usually 3 times daily before meals, will be discontinued. 2. Basal insulin (NPH, Lantus, Levimir, Toujeo or Tresiba), usually once daily at bed time, will be continued at 80 % of the home dose. The dose will be gradually increased until the patient is back on the home dose (the dose that the patient has been taking at home prior to the enrollment) or fasting BG of 80-130mg/dl is achieved by using the self-titration regimen. 3. If the patient is on pre-mixed basal+prandial insulin 2-3 times daily, it will be discontinued and a basal insulin alone, (NPH, Lantus, Levemir, Toujeo or Tresiba), will be given at 40% of total daily dose of pre-mixed insulin. The dose will be gradually increased until fasting BG of 80-130mg/dl is achieved by using the self-titration regimen. 4. Metformin, that most patients are expected to be on, will be continued, but other non-insulin oral medications for diabetes will be discontinued. If the patient is not on metformin, then Metformin ER will be started at 500mg with a meal for 2 weeks as a routine care and then 1000mg daily as a maintenance dose if tolerated. 5. Both SGLT2i and GLP1 RA will be added to metformin and a basal insulin. The patient will be trained on the injection technique of the once-weekly GLP1 RA, potential side effects, risk and benefits of all new medications in detail, hypoglycemia management and the self-titration regimen for the basal insulin. In the control group, there will not be any change in MDI therapy, and the participants will continue to have the usual and standard care through the primary care provider. The participants should not receive SGLT2i and GLP1 RA during the study period. (2) Second visit: At 4 weeks after the patient starts taking new medications, the patients will make the 2nd visit to the UCSF Clinical Research Center. During the 2nd visit, the patient in the treatment group will - be enquired about any side effect of the medications. - be reviewed on insulin dose and the use of self-titration regimen for the basal insulin. - have the blood test for A1c, CMP, CBC, fasting lipid and measurements of body weight, height, blood pressure, and heart rate. - complete both the Diabetes Medications Satisfaction (DM-SAT) Questionnaire form and the modified Morisky Medication Adherence Scale. In the control group, there will not be any change in MDI therapy, and the participants will continue to have the usual and standard care through the primary care provider. The participants should not receive SGLT2i and GLP1 RA during the study period. During the 2nd visit, the patient in the control group will - have the blood test for A1c, CMP, CBC, fasting lipid and measurements of body weight, height, blood pressure, and heart rate. - complete both the Diabetes Medications Satisfaction (DM-SAT) Questionnaire form and the modified Morisky Medication Adherence Scale. (3) Third visit: The patients will make the 3rd or final visit to the UCSF Clinical Research Center at 12 weeks after 2nd visit or 16 weeks from the date of the start of both SGLT2i and a GLP1 RA. During the 3rd visit, the patients in both groups will - have the blood test for A1c, CMP, CBC, fasting lipid and measurements of body weight, height, blood pressure, and heart rate. - complete both the Diabetes Medications Satisfaction (DM-SAT) Questionnaire form and the modified Morisky Medication Adherence Scale. The investigators will try to make a clinic appointment with primary care provider one month prior to the last visit to the research center for those who are in the treatment group if the patient gives the permission to do so. Therefore the primary care provider will be able to order the medications through the patient's health insurance plan if the patient wishes to remain on the study medications beyond the study period. Alternatively, the patients can go back on insulin therapy that was given prior to the study. Monitoring of the treatment group: The patients in both groups will monitor FPGs daily at minimum. The research coordinator will call all participants in both groups at weeks 1, 2, 8, and 12 to review fasting glucose measurements, ask for possible adverse events, incidents of hypoglycemia, and any change in medication. All participants in both groups in both groups will be reviewed again at the UCSF Clinical Research Center at weeks #4 and #16 for both blood tests and physical examinations. Outcome measurements: The primary outcome is the change in A1c at the end of 16 weeks of study period and secondary outcomes are the changes in fasting blood glucose, weight, blood pressure, heart rate, fasting lipids, serum sodium and potassium, serum creatinine, liver enzymes, CBC, medication adherence scores and treatment satisfaction scores . These changes will be compared between the two independent groups, namely the treatment group and the control group, and also within the same group. Blood test and questionnaire: The following blood work will be drawn and analyzed at the community regional medical center at baseline (first visit), at 4 weeks and at the end of the study at 16 weeks: 1. A1c 2. Complete Blood Count (CBC) with differential 3. Complete metabolic panel (CMP) 4. Fasting lipid profile Patient satisfaction with treatment in both groups will be measured by the validated the Diabetes Medications Satisfaction (DM-SAT) Questionnaire form. Patient adherence will be determined by using the modified Morisky Medication Adherence Scale (MMAS-8) that is an eight-item self-report measure of adherence. SAMPLE SIZE AND ANALYSIS PLAN: The investigators will attempt to recruit and consent 20 patients in each arm that was calculated to provide an 80% statistical power at a 0.05 alpha in this continuous endpoint, two independent sample study. The calculation was based on the following: A mean Hemoglobin A1c of 8.5±1% at the initiation of the study period. In the treatment group we anticipate a decline in Hemoglobin A1c of 12-15% by the end of the study period. The standard deviation for the mean A1c was derived from the literature. The data will be analyzed by using SPSS software. Significance testing will be conducted at the two-sided 5% level. Continuous variables will be examined for normality and if assumption is met, differences in mean values will be tested using Student's t test an analysis of variance (ANOVA). If not normally distributed, non-parametric procedures will be used, including Wilcoxan rank Sum test. Categorical data will be analyzed using Fisher's exact test and Chi square analysis. Since before/after comparisons will also be performed on the same study patients we will utilize paired t tests and McNemar's chi-square test.
Condition browse 6e057d790ed61f990a5a45f580391649
Intervention browse 86eed15cff544d6c68ddf65d40e2d616
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact SOE NAING, MD (Contact)
Overall contact backup None
Sponsor group 46e876047261b04c4c3edfb192b7ad79
Oversight info United States: Institutional Review Board (Oversight_info)
Eligibility f9197a0e76f650381bb7c32186fae29b
Keywords None
Conditions Type 2 Diabetes Mellitus
Locations None
Links None
Results references None
Arm groups Control group (Arm Group), Treatment group (Arm Group)
Location countries None
Interventions Metformin (Intervention), basal insulin (Intervention), GLP1 receptor agonist (Intervention), SGLT2 inhibitor (Intervention)
Secondary outcomes 0223a13b7f59ab859fa480f59ba3847f, 1069a288c6f184d481842f9d6149a9d8, 240c5698878c28242eae407157bac145, 26355a91e609b558dac7372c760debf7, 646151757175a5c54f56cb947508cb00, 83540c22933d2a973133ba9897d51465, 9c64fc656305ffcd01f16bf5dd330cbb, 9d21a91bab9c3e921fd9257da2b2137b, ae6edf9f21a66150bcf9585e420e4859, d512a7b83f76118ac98348b1fd6db2c2, e32020f566a3a0743bc9cf6937dacc46, fffe43ac94471152a173c97bc3b2fe54
References None
Primary outcomes 5fab8002f14d137986eecfb985e71486
Removed countries None
Overall officials 191658013399bd0d13c9ede2de882421