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Study on Lixisenatide and Counterregulation to Hypoglycemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02020629
First Posted: December 25, 2013
Last Update Posted: December 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bo Ahren, Lund University
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes Drug: Lixisenatide Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Lixisenatide on Glucagon Secretion During Hypoglycemia in Patients With Insulin-treated Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Bo Ahren, Lund University:

Primary Outcome Measures:
  • Glucagon response to hypoglycemia [ Time Frame: 30 min ]
    Hypoglycemia is induced by clamp during 30 min; glucagon levels are measured during this time frame


Secondary Outcome Measures:
  • Cortisol response to hypoglycemia [ Time Frame: 30 min ]
    Hypoglycemia is induced by a clamp during 30 min. Cortisol is measured during this time frame.

  • Catecholamines [ Time Frame: 30 min ]
    Hypoglycemia is induced by a clamp during 30 min. Catecholamines are measured during this time frame.


Other Outcome Measures:
  • HbA1c [ Time Frame: 6 weeks ]
    Change in HbA1c during six weeks treatment


Enrollment: 18
Study Start Date: December 2013
Study Completion Date: August 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lixisenatide
Lixisenatide 20µg daily
Drug: Lixisenatide
Lixisenatide is given for 6 weeks whereafter a hypoglycemia clamp is undertaken
Other Name: Lyxumia

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020629


Locations
Sweden
Clinical Research Department
Malmö, Sweden, 20502
Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Bo Ahrén, MD, PhD Lund University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bo Ahren, Professor, Lund University
ClinicalTrials.gov Identifier: NCT02020629     History of Changes
Other Study ID Numbers: 16
2012-004959-36 ( EudraCT Number )
First Submitted: December 16, 2013
First Posted: December 25, 2013
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by Bo Ahren, Lund University:
Glucagon
Hypoglycemia
Counterregulation

Additional relevant MeSH terms:
Hypoglycemia
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon
Lixisenatide
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hypoglycemic Agents