Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?
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|ClinicalTrials.gov Identifier: NCT02846233|
Recruitment Status : Completed
First Posted : July 27, 2016
Results First Posted : November 10, 2020
Last Update Posted : November 10, 2020
In traditional step-up approach, the patients with poorly-controlled type 2 diabetes are instructed to take up to 4 insulin injections daily or multiple daily injections (MDI) as the most advanced therapy. However, a significant number of these patients continue to have poor diabetes control. The most common reason is the noncompliance with multiple injections and the patient's reluctance to accept insulin-induced weight gain. More recently, the algorithm in diabetes management has significantly changed to accommodate the newer generation of medications. Addition of the diabetes medications, that can induce weight loss such as oral Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors and once-weekly glucagon-like peptide (GLP)-1 receptor agonists (GLP1 RA) injection, to a basal insulin is now recommended before the patient is advanced to MDI. This approach works very well in most patients since weight loss gives the patients an extra motivation to take medication regularly. Similarly, the patient does not require to take an insulin injection before each meal throughout the day in this approach.
Unfortunately, there are still a large number of patients with poor glycemic control who are still on MDI. Some of them were initiated on MDI before the availability of newer generations of medications. Some were started simply because the physician was not aware of or not the familiar with the new recommendations. Regardless of the reason, these patients are likely to remain on MDI despite chronic poor glycemic control since the physicians are understandably reluctant to step down the most advanced insulin therapy. In addition, there has been no data on the benefits and safety of the stepping-down approach from the most advanced insulin therapy to the more patient-friendly approach that is the combined use of oral SGLT2i and once-weekly GLP1 RA injection.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: GLP1 receptor agonist Drug: basal insulin Drug: SGLT2 inhibitor Drug: Metformin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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?|
|Actual Study Start Date :||August 2016|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
Active Comparator: Treatment group
Interventions: All prandial insulin injections, usually 3 times daily before meals, will be discontinued. Basal insulin, usually once daily at bed time, will be continued at 80 % of the home dose. Albiglutide OR Dulaglutide AND Empagliflozin will be added to metformin and a basal insulin.
Drug: GLP1 receptor agonist
"Albiglutide or Dulaglutide" will be added to a basal insulin.
Other Name: Albiglutide (Tanzeum) or , Dulaglutide (Trulicity)
Drug: basal insulin
The participant will continue with the basal insulin.
Other Name: Lantus, Toujeo, NPH, levemir
Drug: SGLT2 inhibitor
"Empagliflozin" will be added to a basal insulin.
Other Name: Empagliflozin (Jardiance)
The participant will continue with metformin.
No Intervention: Control group
Interventions: There will not be any change in insulin therapy, and they will continue to have the usual and standard care through the primary care provider. They should not receive SGLT2i and GLP1 RA during the study period.
- Change in A1c at the End of Study Period [ Time Frame: 16 weeks (from baseline to end of study at 16 weeks) ]change in A1c (%) from baseline to end of study at 16 weeks
- Changes in Weight [ Time Frame: 16 weeks (from baseline to end of study at 16 weeks) ]change (in pounds) from baseline to the end of study at 16 weeks
- Changes in Blood Pressure [ Time Frame: 16 weeks (from baseline to end of study at 16 weeks) ]change (mmHg) of systolic BP from baseline to the end of study at 16 weeks
- Changes in Heart Rate [ Time Frame: 16 weeks ]change (beats/min) from baseline to the end of study at 16 weeks
- Changes in LDL [ Time Frame: 16 weeks (from baseline to end of study at 16 weeks) ]change (mg/dL) from baseline to the end of study at 16 weeks
- Changes in Total Cholesterol [ Time Frame: 16 weeks (from baseline to end of study at 16 weeks) ]change (mg/dL) from baseline to the end of study at 16 weeks
- Changes in Serum Creatinine [ Time Frame: 16 weeks (from baseline to end of study at 16 weeks) ]change (mg/dL) from baseline to the end of study at 16 weeks
- Changes in Treatment Satisfaction Scores (DM-SAT Total Score) [ Time Frame: 16 weeks (from baseline to end of study at 16 weeks) ]Patient satisfaction with treatment in both groups will be measured by the validated the Diabetes Medications Satisfaction Tool (DM-SAT). Response options range from 0="not at all satisfied" to 10="extremely satisfied" and a total score is calculated ranging from 0 to 100, with higher scores indicating more diabetes medication satisfaction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846233
|United States, California|
|Fresno, California, United States, 93701|
|Principal Investigator:||SOE NAING, MD||UCSF - Fresno|