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CompletedPhase 4

Study on Lixisenatide and Counterregulation to Hypoglycemia

Effect of Lixisenatide on Glucagon Secretion During Hypoglycemia in Patients With Insulin-treated Type 2 Diabetes

Lead sponsor

Lund University

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

18

actual

Study population

Type 2 diabetes

Key I/E criterion

HbA1c ≤10%

Primary endpoint

Glucagon response to hypoglycemia

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

NCT IDNCT02020629
Org study ID16
Secondary ID2012-004959-36

Timeline

Milestones

Study first posted2013-12-25estimated
Last update posted2015-12-15estimated
Study start2013-12 (month precision)
Primary completion2014-08actual (month precision)
Study completion2015-08actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male, non-fertile female or female of childbearing potential using a medically approved birth control method aged >18 years.

2. Adult patients with type 2 diabetes treated with basal insulin (NPH insulin, insulin detemir, insulin glargine or insulin degludec) (stable insulin dose (±10%) during the last three months) with concomitant at >3 months stable dose (>1500 mg daily) of metformin.

3. HbA1c <10% (DCCT standard; < 83 mmol(mol) at visit 1.

Exclusion criteria

1. Treatment with antihyperglycemic agents apart from basal insulin and metformin, i.e., bolus insulin or other antihyperglycemic oral agents apart from metformin

2. Type 1 diabetes (including LADA)

3. Pregnant or lactating female. Women of childbearing potential with no effective contraceptive method. Acceptable contraceptive include contraceptive sponge; hormonal contraception pills, patches, vaginal rings, injectable contraceptives; and intrauterine devices. Women of childbearing potential (pre-menopausal, not surgically sterile women for at least 3 months prior to the time of screening) must have a confirmed negative serum pregnancy test at screening visit. They must use an effective contraceptive method throughout the study, and agree to repeat pregnancy tests at designated visits. The applied methods of contraception have to meet the criteria for a highly effective method of birth control according to the "Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95)"

4. A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.

5. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1

6. Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes or hypoglycemia unawareness

7. Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.

8. Treatment with growth hormone and oral or parenteral corticosteroid (> 7 consecutive days of treatment) within 8 weeks prior to visit 1 and thereafter during the whole study period.

9. Use of other investigational drugs within 30 days prior to visit 1.

10. Laboratory findings at the time of screening, including amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN) and P-calcitonin ≥20 pg/ml (5.9 pmol/L).

11. Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes).

12. History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery

13. Allergic reaction to any GLP-1 receptor agonist or to metacresol

14. Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting,

15. Cardiovascular, hepatic, neurological, or endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult.

Endpoints (4)

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
2
Other (unclassified)
2

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Glucagon response to hypoglycemia

Time frame:30 min

descriptive

Other/protocol endpoint

HbA1c

Time frame:6 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Cortisol response to hypoglycemia

Time frame:30 min

descriptive

Secondary/protocol endpoint/low confidence

Catecholamines

Time frame:30 min

concentration, descriptive

Publications (1)

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.