Study on Lixisenatide and Counterregulation to Hypoglycemia
Verified December 2013 by Lund University
Information provided by (Responsible Party):
Bo Ahren, Lund University
First received: December 16, 2013
Last updated: December 19, 2013
Last verified: December 2013
In hypoglycemia, there is a counterregulation to restore glucose levels. An important part of this counterregulation is the release of the hormone glucagon. Since the GLP-1 receptor agonist lixisenatide has been shown to be associated with a low risk of hypoglycemia, this study examines whether lixisenatide affects the glucagon response to hypoglycemia.
Type 2 Diabetes
||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
||Effect of Lixisenatide on Glucagon Secretion During Hypoglycemia in Patients With Insulin-treated Type 2 Diabetes
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
Lixisenatide 20µg daily
Lixisenatide is given for 6 weeks whereafter a hypoglycemia clamp is undertaken
Other Name: Lyxumia
The study is a single-center, randomized, placebo-controlled study with a cross-over design and examines the glucagon response during a hyperinsulinemic hypoglycemic phase after a 6-week treatment with lixisenatide (or placebo) as add-on to basal insulin and metformin. The hypothesis of the study is that the glucagon counterregulation to hypoglycemia in patients treated with lixisenatide and basal insulin is not lower than in patients treated with basal insulin.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male, non-fertile female or female of childbearing potential using a medically approved birth control method aged >18 years.
- 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.
- HbA1c <10% (DCCT standard; < 83 mmol(mol) at visit 1.
- Treatment with antihyperglycemic agents apart from basal insulin and metformin, i.e., bolus insulin or other antihyperglycemic oral agents apart from metformin
- Type 1 diabetes (including LADA)
- 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)"
- A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
- Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
- Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes or hypoglycemia unawareness
- 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.
- 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.
- Use of other investigational drugs within 30 days prior to visit 1.
- 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).
- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes).
- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery
- Allergic reaction to any GLP-1 receptor agonist or to metacresol
- Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting,
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02020629
||Bo Ahrén, MD, PhD
No publications provided
||Bo Ahren, Professor, Lund University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 16, 2013
||December 19, 2013
||Sweden: Medical Products Agency
Keywords provided by Lund University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 14, 2014
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases