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NCT02846233 · ClinicalTrials.gov registry record · NA

Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?

A NA study of Type 2 Diabetes Mellitus, sponsored by University of California, San Francisco.

Completed
Registry status
NA
Development phase
22
Enrollment target
1
Study location

NCT02846233 is a NA study of Type 2 Diabetes Mellitus that has completed, run by University of California, San Francisco. The registered enrollment target is 22 participants, below the 2,748-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02846233, a NA study of Type 2 Diabetes Mellitus, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
NA
Development phase
22 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DRUG Metformin
  • DRUG SGLT2 inhibitor
  • DRUG GLP1 receptor agonist
  • DRUG basal insulin

Study Locations (1)

California

  • UCSF Fresno - Fresno

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2016-08
Est. Completion 2018-12
Phase NA

What the Registry Record Tells You About NCT02846233

The ClinicalTrials.gov registry entry for NCT02846233 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,748-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 4 interventions - of which Metformin is the first listed.

NCT02846233 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT02846233 about?

NCT02846233 is a clinical study titled "Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?". 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 mo...

What is the current status of trial NCT02846233?

This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2016-08. Estimated completion is 2018-12.

What conditions does trial NCT02846233 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.

What interventions are being tested in trial NCT02846233?

The interventions under investigation include: Metformin (DRUG), SGLT2 inhibitor (DRUG), GLP1 receptor agonist (DRUG), basal insulin (DRUG).

Who is sponsoring clinical trial NCT02846233?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02846233 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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