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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
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)

Drug: Metformin
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Changes in Heart Rate [ Time Frame: 16 weeks ]
    change (beats/min) from baseline to the end of study at 16 weeks

  4. 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

  5. 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

  6. 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

  7. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, California
UCSF Fresno
Fresno, California, United States, 93701
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: SOE NAING, MD UCSF - Fresno
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02846233    
Other Study ID Numbers: RDMSTEP
First Posted: July 27, 2016    Key Record Dates
Results First Posted: November 10, 2020
Last Update Posted: November 10, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Empagliflozin
Dulaglutide
Sodium-Glucose Transporter 2 Inhibitors
rGLP-1 protein
Hypoglycemic Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists