- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02020629
Study on Lixisenatide and Counterregulation to Hypoglycemia
December 12, 2015 updated by: Bo Ahren, Lund University
Effect of Lixisenatide on Glucagon Secretion During Hypoglycemia in Patients With Insulin-treated Type 2 Diabetes
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Malmö, Sweden, 20502
- Clinical Research Department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Lixisenatide
Lixisenatide 20µg daily
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Lixisenatide is given for 6 weeks whereafter a hypoglycemia clamp is undertaken
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucagon response to hypoglycemia
Time Frame: 30 min
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Hypoglycemia is induced by clamp during 30 min; glucagon levels are measured during this time frame
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30 min
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortisol response to hypoglycemia
Time Frame: 30 min
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Hypoglycemia is induced by a clamp during 30 min.
Cortisol is measured during this time frame.
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30 min
|
Catecholamines
Time Frame: 30 min
|
Hypoglycemia is induced by a clamp during 30 min.
Catecholamines are measured during this time frame.
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30 min
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: 6 weeks
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Change in HbA1c during six weeks treatment
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6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (ACTUAL)
August 1, 2014
Study Completion (ACTUAL)
August 1, 2015
Study Registration Dates
First Submitted
December 16, 2013
First Submitted That Met QC Criteria
December 19, 2013
First Posted (ESTIMATE)
December 25, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
December 15, 2015
Last Update Submitted That Met QC Criteria
December 12, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16
- 2012-004959-36 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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