Study of Effectiveness of Liraglutide Added to High Dose Insulin in Type II Diabetics
Liraglutide and Insulin-001 A Randomized Prospective Trial of Liraglutide Added to High-Dose Insulin Therapy vs. High-Dose Insulin Therapy Alone in Insulin-Resistant Patients With Type 2 Diabetes
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
-
Actual enrollment
37
Study population
Type 2 diabetes
Eligibility highlights
•HbA1c 6.5-10%
Primary endpoint
•HbA1c, change
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. Male and female patients with Type 2 diabetes with HbA1c from 6.5 to 10% treated with intensive insulin therapy (MDI or CSII, including U-500 insulin-treated patients) using > 100 units of insulin, with or without a stable dose of oral insulin sensitizing medications, for at least three months.
2. Aged 18 to 80 years.
3. Females of child-bearing potential must be using adequate form of contraception.
4. Patient willing to monitor BG four times daily, use CGM, and comply with study-related protocol.
Exclusion criteria
1. Type 1 diabetes.
2. Use of any GLP-1 receptor agonist within previous three months.
3. Use of DPP-4 inhibitors or oral insulin secretagogues within the previous three months.
4. Use of glucocorticoids (except inhaled).
5. Use of any experimental drug within previous three months.
6. Known or suspected allergy to liraglutide, Novolog or Levemir.
7. Personal or family history of medullary carcinoma of the thyroid or MEN-2.
8. Concomitant chronic renal disease with creatinine > 1.5%.
9. Concomitant chronic hepatic, gastrointestinal or other illness (including pancreatitis or active cardiovascular disease except stable exertional angina).
10. Inability or unwillingness to monitor BG, use CGM, or comply with study protocol.
11. Women of child-bearing potential unwilling to use adequate contraception, intending to become pregnant or breast-feeding.
Endpoints (5)
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
1 endpointWeight
Time frame:baseline, 3, 6, 9, and 12 months
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
3 endpointsChange from baseline in HbA1c at six months
Time frame:baseline and six months
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Total Daily Insulin Dose (TDID)
Time frame:3, 6, 9, and 12 months
descriptive
GlycoMark
Time frame:baseline, 3, 6, 9, and 12 months
change from baseline, improvement
Safety / tolerability / PK
1 endpointHypoglycemia
Time frame:6 months and 12 months
Documented hypoglycemia
event count, event
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 6, 2026 snapshot.