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Type 2 DiabetesPhase 4NCT02020629

Study on Lixisenatide and Counterregulation to Hypoglycemia

A Phase 4 study testing Lixisenatide in people with Type 2 Diabetes, run by Lund University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Lixisenatide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteSweden
Study dates
Dec 2013to Aug 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Clinical Research Department

    Malmö, 20502

Other trials in Sweden

About this study

Official title: 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.

Read the 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.

Conditions
Type 2 Diabetes
Being tested
Lixisenatide
Keywords
Glucagon, Hypoglycemia, Counterregulation
Medical subject headings
Diabetes Mellitus, Type 2, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LixisenatideDrug

    Also called Lyxumia

    Lixisenatide is given for 6 weeks whereafter a hypoglycemia clamp is undertaken

Study groups in NCT02020629
Study groupRoleWhat they receive
LixisenatideExperimentalLixisenatide 20µg daily
Receives: Drug: Lixisenatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glucagon response to hypoglycemia

    Hypoglycemia is induced by clamp during 30 min; glucagon levels are measured during this time frame

    Measured: 30 min

Secondary outcomes (2)

  1. Cortisol response to hypoglycemia

    Hypoglycemia is induced by a clamp during 30 min. Cortisol is measured during this time frame.

    Measured: 30 min

  2. Catecholamines

    Hypoglycemia is induced by a clamp during 30 min. Catecholamines are measured during this time frame.

    Measured: 30 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionAug 2014
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02020629
Sponsor's protocol ID
16
Other IDs
2012-004959-36
Status last verified
Dec 2015
First submitted
16 Dec 2013
Last updated
15 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Farngren J, Persson M, Ahren B. Effect of the GLP-1 Receptor Agonist Lixisenatide on Counterregulatory Responses to Hypoglycemia in Subjects With Insulin-Treated Type 2 Diabetes. Diabetes Care. 2016 Feb;39(2):242-9. doi: 10.2337/dc15-1274. Epub 2015 Nov 4.

    PubMed 26537183

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lixisenatide in people with Type 2 Diabetes, run by Lund University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glucagon response to hypoglycemia (time frame: 30 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02020629, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015.

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