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Delfa

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CompletedPhase 4

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

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

NCT IDNCT01654120
Org study IDhigh dose and lira 001

Timeline

Milestones

Study first posted2012-07-31estimated
Last update posted2021-02-25actual
Study start2011-12 (month precision)
Primary completion2013-11actual (month precision)
Study completion2013-11actual (month precision)

Assets

Investigational agents

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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

Glycemic / diabetes
3
Weight & body composition
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Weight

Time frame:baseline, 3, 6, 9, and 12 months

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Change from baseline in HbA1c at six months

Time frame:baseline and six months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Total Daily Insulin Dose (TDID)

Time frame:3, 6, 9, and 12 months

descriptive

Secondary/protocol endpoint

GlycoMark

Time frame:baseline, 3, 6, 9, and 12 months

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Hypoglycemia

Time frame:6 months and 12 months

Documented hypoglycemia

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.