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Diabetes Mellitus, Type 2Phase 4NCT02765204

A Single-dose Cross-over Study to Assess Direct and Indirect Effects of Dapagliflozin on Pancreatic Alpha and Beta Cells in Patients With Type 2 Diabetes

A Phase 4 study testing Dapagliflozin, Saxagliptin and Glucose in people with Diabetes Mellitus, Type 2, run by Uppsala 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
Search all trials

Trial summary

The purpose of this study is to evaluate if Dapagliflozin has direct effect on alpha cell glucagon release. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Dapagliflozin, Saxagliptin and Glucose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSweden
Study dates
Mar 2016to Dec 2016
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females aged 18 - 75.
  • Female subjects must meet all of the following criteria:
  • Not breastfeeding
  • Negative pregnancy test result (human chorionic gonadotropin, beta subunit [hCG]) at Visit 0 (screening) (not applicable to hysterectomized females).
  • If of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year), must practice and be willing to continue to practice one of the following highly effective birth control methods during the entire duration of the study:
  • Diaphragm or partner use of condom in combination with combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
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  • Oral
  • Intravaginal
  • Transdermal ii. Diaphragm or partner use of condom in combination with progestogen-only hormonal contraception associated with inhibition of ovulation:
  • Oral
  • Injectable
  • Implantable iii. Placement of an intrauterine device iv. Placement of an intrauterine hormone-releasing system v. Bilateral tubal occlusion vi. Vasectomised partner (provided that the partner is the sole sexual partner of the female subject and that the vasectomised partner has received medical assessment of the surgical success) vii. Sexual abstinence (defined as refraining from heterosexual intercourse) d) Must practice appropriate birth control as stated above for 10 weeks after the last dose of study medication
  • BMI 20 - 35.
  • Clinical T2D diagnosis at least 6 months prior to enrolment.
  • Metformin treatment, with stable dose for at least 1 month.
  • HbA1c 55 - 86 mmol/mol (7,2-10 % DCCT).

Who cannot join

  • History or sign of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
  • Clinical diagnosis of Type 1 diabetes mellitus and/or history of diabetic ketoacidosis or positive Glutamic Acid Decarboxylase Autoantibodies test (GAD antibodies test).
  • Patients treated with antipsychotics, systemic glucocorticoids, neuropsychiatric stimulants, antidepressants with sympathetic activity, beta blockers or other pharmaceuticals rendering patient unfit for study participation as judged by the investigator.
  • Patients treated with antidiabetic medications other than Metformin.
  • Patients with any other endocrine disease except substituted hypothyroidism.
  • Significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN.
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  • Patients with impaired liver or kidney function (eGFR < 60).
  • Known or suspected history of significant drug abuse.
  • History of alcohol abuse or excessive intake of alcohol as judged by investigator.
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator.
  • Plasma donation within one month of screening or any blood donation or significant blood loss (> 400 ml) during the 3 months prior to screening.
  • Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study and /or for the patients safety.
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  • Judgment by the investigator that the subject should not participate in the study if considers subject unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Dept of Medical Sciences Uppsala University Hospital

    Uppsala, 75185

Other trials in Sweden

About this study

The purpose of this study is to evaluate if Dapagliflozin has direct effect on alpha cell glucagon release.

Being tested
Dapagliflozin, Saxagliptin, Glucose
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

Study groups in NCT02765204
Study groupRoleWhat they receive
DS-D-DGExperimentalThe arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
Receives: Drug: Dapagliflozin; Drug: Saxagliptin; Drug: Glucose
DS-DG-DExperimentalThe arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
Receives: Drug: Dapagliflozin; Drug: Saxagliptin; Drug: Glucose
D-DG-DSExperimentalThe arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
Receives: Drug: Dapagliflozin; Drug: Saxagliptin; Drug: Glucose
D-DS-DGExperimentalThe arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
Receives: Drug: Dapagliflozin; Drug: Saxagliptin; Drug: Glucose
DG-D-DSExperimentalThe arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
Receives: Drug: Dapagliflozin; Drug: Saxagliptin; Drug: Glucose
DG-DS-DExperimentalThe arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
Receives: Drug: Dapagliflozin; Drug: Saxagliptin; Drug: Glucose

What is being measured

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

  1. Change in plasma glucagon levels from baseline to 0.5 hour after single-dose administration of drug.

    Washout period of 2-6 weeks between the interventions

    Measured: At start and 0.5 hour after the start of each intervention

  2. Change in plasma glucagon levels from baseline to 1 hour after single-dose administration of drug.

    Measured: At start and 1 hour after the start of each intervention

  3. Change in plasma glucagon levels from baseline to 2 hours after single-dose administration of drug.

    Measured: At start and 2 hours after the start of each intervention

  4. Change in plasma glucagon levels from baseline to 3 hours after single-dose administration of drug.

    Measured: At start and 3 hours after the start of each intervention

  5. Change in plasma glucagon levels from baseline to 5 hours after single-dose administration of drug.

    Measured: At start and 5 hours after the start of each intervention

  6. Change in plasma glucagon levels from baseline to 5.5 hours after single-dose administration of drug.

    Measured: At start and 5.5 hours after the start of each intervention

  7. Change in plasma glucagon levels from baseline to 6 hours after single-dose administration of drug.

    Measured: At start and 6 hours after the start of each intervention

  8. Change in plasma glucagon levels from baseline to 7 hours after single-dose administration of drug.

    Measured: At start and 7 hours after the start of each intervention

Timeline

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

  1. First posted6 May 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02765204
Sponsor's protocol ID
ESR-15-11421
Other IDs
2015-005549-30, 2015
Status last verified
Dec 2016
First submitted
14 Apr 2016
Last updated
12 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • Lundkvist P, Pereira MJ, Kamble PG, Katsogiannos P, Langkilde AM, Esterline R, Johnsson E, Eriksson JW. Glucagon Levels During Short-Term SGLT2 Inhibition Are Largely Regulated by Glucose Changes in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2019 Jan 1;104(1):193-201. doi: 10.1210/jc.2018-00969.

    PubMed 30137410

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozin, Saxagliptin and Glucose in people with Diabetes Mellitus, Type 2, run by Uppsala 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 16 inclusion and 14 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 12 Dec 2016. 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?

Change in plasma glucagon levels from baseline to 0.5 hour after single-dose administration of drug. (time frame: At start and 0.5 hour after the start of each intervention). The study lists 8 primary outcomes in all. 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 NCT02765204, 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 12 Dec 2016.

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Clinical Trial NCT02765204 | AzTrials