- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02765204
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
December 9, 2016 updated by: Uppsala University
The purpose of this study is to evaluate if Dapagliflozin has direct effect on alpha cell glucagon release.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
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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Uppsala, Sweden, 75185
- Dept of Medical Sciences Uppsala University Hospital
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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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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:
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:
- 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 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: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
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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).
|
|
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).
|
|
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).
|
|
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).
|
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Washout period of 2-6 weeks between the interventions
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At start and 0.5 hour after the start of each intervention
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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
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At start and 1 hour after the start of each intervention
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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
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At start and 2 hours after the start of each intervention
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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
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At start and 3 hours after the start of each intervention
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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
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At start and 5 hours after the start of each intervention
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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
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At start and 5.5 hours after the start of each intervention
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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
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At start and 6 hours after the start of each intervention
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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
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At start and 7 hours after the start of each intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jan W Eriksson, MD PhD, Uppsala University
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
March 1, 2016
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
April 14, 2016
First Submitted That Met QC Criteria
May 4, 2016
First Posted (Estimate)
May 6, 2016
Study Record Updates
Last Update Posted (Estimate)
December 12, 2016
Last Update Submitted That Met QC Criteria
December 9, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Sodium-Glucose Transporter 2 Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Dapagliflozin
- Saxagliptin
Other Study ID Numbers
- ESR-15-11421
- 2015-005549-30 (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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