Primary outcomeMean· 16 weeks (from baseline to end of study at 16 weeks)
Change in A1c at the End of Study Period
| Group | Value (% change of A1c) |
|---|---|
| Treatment Group | -2.38 |
| Control Group | -0.83 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataStepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?
NCTNCT02846233 (opens ClinicalTrials.gov in a new tab)Other idRDMSTEP
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 22 participants (actual)
- Sponsor
- University of California, San Francisco · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Aug 2016
- Primary completion
- Dec 2018
- Completion
- Dec 2018
- First posted
- 27 Jul 2016 (estimated)
- Last update posted
- 10 Nov 2020
- Conditions
- Type 2 Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2016201720182019
- N/A
Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?
NCT02846233Aug 2016 to Dec 2018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- GLP1 receptor agonistDrug
- basal insulinDrug
- SGLT2 inhibitorDrug
- MetforminDrug
Arms2
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.
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in A1c at the End of Study Period
Time frame · 16 weeks (from baseline to end of study at 16 weeks)
Registry description
change in A1c (%) from baseline to end of study at 16 weeks
Secondary outcomes(7)
Changes in Weight
Time frame · 16 weeks (from baseline to end of study at 16 weeks)
Registry description
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)
Registry description
change (mmHg) of systolic BP from baseline to the end of study at 16 weeks
Changes in Heart Rate
Time frame · 16 weeks
Registry description
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)
Registry description
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)
Registry description
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)
Registry description
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)
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· 16 weeks (from baseline to end of study at 16 weeks)
Changes in Weight
| Group | Value (pounds) |
|---|---|
| Treatment Group | -16.38 |
| Control Group | -0.1 |
Secondary outcomeMean· 16 weeks (from baseline to end of study at 16 weeks)
Changes in Blood Pressure
| Group | Value (mmHg) |
|---|---|
| Treatment Group | -16 |
| Control Group | 15 |
Secondary outcomeMean· 16 weeks
Changes in Heart Rate
| Group | Value (beats per min) |
|---|---|
| Treatment Group | 4.3 |
| Control Group | 5.13 |
Secondary outcomeMean· 16 weeks (from baseline to end of study at 16 weeks)
Changes in LDL
| Group | Value (mg/dL) |
|---|---|
| Treatment Group | -15.7 |
| Control Group | 21 |
Secondary outcomeMean· 16 weeks (from baseline to end of study at 16 weeks)
Changes in Total Cholesterol
| Group | Value (mg/dL) |
|---|---|
| Treatment Group | -18.5 |
| Control Group | 18.38 |
Secondary outcomeMean· 16 weeks (from baseline to end of study at 16 weeks)
Changes in Serum Creatinine
| Group | Value (mg/dL) |
|---|---|
| Treatment Group | 0.04 |
| Control Group | 0.04 |
Secondary outcomeMean· 16 weeks (from baseline to end of study at 16 weeks)
Changes in Treatment Satisfaction Scores (DM-SAT Total Score)
| Group | Value (score on a scale) |
|---|---|
| Treatment Group | 45.3 |
| Control Group | 4.63 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Treatment GroupInterventions: 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. GLP1 receptor agonist: "Albiglutide or Dulaglutide" will be added to a basal insulin. basal insulin: The participant will continue with the basal insulin. SGLT2 inhibitor: "Empagliflozin" will be added to a basal insulin. Metformin: The participant will continue with metformin. | 0 / 12 | 0 / 12 | 10 / 12 |
| Control GroupInterventions: 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. | 0 / 10 | 0 / 10 | 3 / 10 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 21 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
The following patients with diabetes mellitus type 2 who can give written consent will be eligible for enrollment. They must meet all criteria.
1. \> 21 years of age
2. Body mass index (BMI) ≥30 kg/m2
3. On insulin at least 2 times daily comprising both a basal and a prandial insulin or a pre-mix insulin with or without other non-insulin medications for a least past 3 months
4. A1c \>8%
5. eGFR \>45%
Exclusion Criteria:
The patients with any of the following criteria will be excluded.
1. Any patient who does not meet the above inclusion criteria.
2. Pregnancy
3. Patients who are on a SGLT2i and a GLP1 RA injection at the time of enrollment.
4. diabetes mellitus type 1
5. C-peptide below normal range if measured in the past.
6. patients with a history of diabetes ketoacidosis
7. A history of recent and frequent (≥ 2 times within past 3 months) urinary tract infection or genito-urinary candidiasis requiring antibiotic and/or anti-fungal therapies.
8. a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
9. eGFR \<45%
10. patients with a history of acute pancreatitis
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