← Trials/Trial dossier/NCT02846233
Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?
Is the Stepping-down Approach a Better Option Than Multiple Daily Injections in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?
Lead sponsor
Assets
Albiglutide / Dulaglutide / GLP-1 / incretin class catch-all
Listed sites
1
Recruiting sites
—
Enrollment
22
actual
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criteria
•BMI ≥30•HbA1c ≥8%•eGFR ≥45
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (16)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsChanges in Weight
Time frame:16 weeks (from baseline to end of study at 16 weeks)
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), pounds | 95% CI |
|---|---|---|
| Treatment Group | -16.38 | -25.63 – -7.13 |
| Control Group | -0.1 | -1.34 – 1.14 |
Changes in Weight
Time frame:16 weeks (from baseline to end of study at 16 weeks)
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
2 endpointsChange in A1c at the End of Study Period
Time frame:16 weeks (from baseline to end of study at 16 weeks)
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), % change of A1c | 95% CI |
|---|---|---|
| Treatment Group | -2.38 | -2.93 – -1.83 |
| Control Group | -0.83 | -2.05 – 0.40 |
Change in A1c at the End of Study Period
Time frame:16 weeks (from baseline to end of study at 16 weeks)
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Renal / kidney
2 endpointsChanges in Serum Creatinine
Time frame:16 weeks (from baseline to end of study at 16 weeks)
change from baseline, improvement
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Treatment Group | 0.04 | -0.08 – 0.16 |
| Control Group | 0.04 | -0.04 – 0.11 |
Changes in Serum Creatinine
Time frame:16 weeks (from baseline to end of study at 16 weeks)
change from baseline, improvement
Cardiometabolic biomarkers
8 endpointsChanges in Blood Pressure
Time frame:16 weeks (from baseline to end of study at 16 weeks)
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Posted result
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| Treatment Group | -16 | -33.37 – 1.37 |
| Control Group | 15 | 2.56 – 27.44 |
Changes in Heart Rate
Time frame:16 weeks
Heart rate, change
change from baseline, improvement
Posted result
| Group | Value (mean), beats per min | 95% CI |
|---|---|---|
| Treatment Group | 4.3 | -1.05 – 9.65 |
| Control Group | 5.13 | -3.93 – 14.18 |
Changes in LDL
Time frame:16 weeks (from baseline to end of study at 16 weeks)
LDL-C, change
change from baseline, improvement
LOINC 13457-7
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Treatment Group | -15.7 | -30.29 – -1.11 |
| Control Group | 21 | -9.9 – 51.9 |
Changes in Total Cholesterol
Time frame:16 weeks (from baseline to end of study at 16 weeks)
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Treatment Group | -18.5 | -35.79 – -1.21 |
| Control Group | 18.38 | -22.38 – 59.13 |
Changes in Blood Pressure
Time frame:16 weeks (from baseline to end of study at 16 weeks)
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Changes in Heart Rate
Time frame:16 weeks
Heart rate, change
change from baseline, improvement
Changes in LDL
Time frame:16 weeks (from baseline to end of study at 16 weeks)
LDL-C, change
change from baseline, improvement
LOINC 13457-7
Changes in Total Cholesterol
Time frame:16 weeks (from baseline to end of study at 16 weeks)
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Patient-reported / QoL
2 endpointsChanges in Treatment Satisfaction Scores (DM-SAT Total Score)
Time frame:16 weeks (from baseline to end of study at 16 weeks)
change from baseline, improvement
Posted result
| Group | Value (mean), score on a scale | 95% CI |
|---|---|---|
| Treatment Group | 45.3 | 28.19 – 62.41 |
| Control Group | 4.63 | -0.83 – 10.08 |
Changes in Treatment Satisfaction Scores (DM-SAT Total Score)
Time frame:16 weeks (from baseline to end of study at 16 weeks)
change from baseline, improvement
Publications (3)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2016 Jan (month)PMID26731084doi:10.4158/EP151126.CSvia CT.gov background
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.