CompletedNCT02765204Updated Dec 12, 2016

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 interventional study of Dapagliflozin and Saxagliptin in Diabetes Mellitus, Type 2, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-12-12.

Sponsored by Uppsala University · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 15
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

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

Conditions studied

Diabetes Mellitus, Type 2

Browse trials for

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 15 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Males and females aged 18 - 75.
Female subjects must meet all of the following criteria:
1. Not breastfeeding
2. Negative pregnancy test result (human chorionic gonadotropin, beta subunit [hCG]) at Visit 0 (screening) (not applicable to hysterectomized females).
3. 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:
i. Diaphragm or partner use of condom in combination with combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- 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).

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 15 participants (actual)

Study arms

Experimental
DS-D-DG
The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
Drug: Dapagliflozin · Drug: Saxagliptin · Drug: Glucose
Experimental
DS-DG-D
The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
Drug: Dapagliflozin · Drug: Saxagliptin · Drug: Glucose
Experimental
D-DG-DS
The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
Drug: Dapagliflozin · Drug: Saxagliptin · Drug: Glucose
Experimental
D-DS-DG
The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
Drug: Dapagliflozin · Drug: Saxagliptin · Drug: Glucose
Experimental
DG-D-DS
The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
Drug: Dapagliflozin · Drug: Saxagliptin · Drug: Glucose
Experimental
DG-DS-D
The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
Drug: Dapagliflozin · Drug: Saxagliptin · Drug: Glucose

Interventions

DrugDapagliflozin
DrugSaxagliptin
DrugGlucose

What researchers measure

Primary outcomes

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
Time frame: At start and 0.5 hour after the start of each intervention
Change in plasma glucagon levels from baseline to 1 hour after single-dose administration of drug.
Time frame: At start and 1 hour after the start of each intervention
Change in plasma glucagon levels from baseline to 2 hours after single-dose administration of drug.
Time frame: At start and 2 hours after the start of each intervention
Change in plasma glucagon levels from baseline to 3 hours after single-dose administration of drug.
Time frame: At start and 3 hours after the start of each intervention
Change in plasma glucagon levels from baseline to 5 hours after single-dose administration of drug.
Time frame: At start and 5 hours after the start of each intervention
Change in plasma glucagon levels from baseline to 5.5 hours after single-dose administration of drug.
Time frame: At start and 5.5 hours after the start of each intervention
Change in plasma glucagon levels from baseline to 6 hours after single-dose administration of drug.
Time frame: At start and 6 hours after the start of each intervention
Change in plasma glucagon levels from baseline to 7 hours after single-dose administration of drug.
Time frame: At start and 7 hours after the start of each intervention

Study locations

1 site

Dept of Medical Sciences Uppsala University Hospital
Uppsala, 75185, Sweden

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02765204
Lead sponsor: Uppsala University
Collaborators: AstraZeneca
Responsible party: Sponsor
First posted: May 6, 2016
Start date: Mar 2016
Primary completion: Dec 2016
Completion: Dec 2016
Last update: Dec 12, 2016

Study contacts

Jan W Eriksson, MD PhD

principal investigator · Uppsala University

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus→

Other studies from this sponsor

Uppsala University

Start the discussion