Fasting GlucosePhase 4DapaT1DMNCT02211742
Dapagliflozin in Type 1 Diabetes
A Phase 4 study testing Dapagliflozin in people with Fasting Glucose and Glucose Excursion, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Dapagliflozin is a highly selective, reversible and potent inhibitor of the sodium-glucose-linked Transporter 2 (SGLT2), which was successfully investigated for its use as a treatment option in type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Fasting Glucose, Glucose Excursion, Glycemic Control
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2014to 8 Feb 2017
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 diabetes mellitus (duration of disease at least 5 years)
- C-peptide concentration < 0.2µg/l
- male sex
- aged 18 to 60 years
- Body Mass Index 20 - 25 kg/m2
- no measurable, clinically relevant ketonuria
Who cannot join
- insufficient venous status on both forearms
- renal and/or hepatic insufficiency (including microalbuminuria and/or albumin/creatinin-ratio)
- history of cancer
- intake of medication and/or substances capable to influence insulin sensitivity within the last 3 months prior to study inclusion
- alcohol- and/or drug abuse, nicotine consumption > 5 cigarettes / 24h
- brittle-diabetes
- history of severe hypoglycemia, defined as the need for foreign assistance independent of actual blood glucose concentration measured
- history or evidence of any other clinically significant disorder, condition or disease other than those outlined above that, in the opinion of the investigator may compromise the ability of the participant to give written informed consent, would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Innsbruck, Department of Internal Medicine I
Innsbruck, Tyrol, 6020
About this study
Official title: Short-term Effects of Dapagliflozin on Fasting and Postprandial Glucose Homeostasis in Male Type 1 Diabetes Patients.
Dapagliflozin is a highly selective, reversible and potent inhibitor of the sodium-glucose-linked Transporter 2 (SGLT2), which was successfully investigated for its use as a treatment option in type 2 diabetes mellitus. The effect of dapagliflozin is an increased glucosuria, and it was shown that mean blood glucose concentrations and postprandial glucose excursion in special were significantly reduced in type 2 diabetic patients. Due to its mechanism-of action it seems likely that also type 1 diabetic patients will benefit from dapagliflozin. The present study is focused on the effects of dapagliflozin on fasting glucose homeostasis and postprandial glucose excursion in male type 1diabetic patients. Participants will subsequently receive 10 milligrams of dapagliflozin and placebo for 3 days (equals 2 x 30mg per cross-over period) in a double-blind, randomised, cross-over design. The effects will be measured via euglycemic hyperinsulinemic clamp studies (fasting glucose homeostasis) and euglycemic oral glucose tolerance clamp tests (postprandial glucose excursions).
- Conditions
- Fasting Glucose, Glucose Excursion, Glycemic Control
- Being tested
- Dapagliflozin
- Keywords
- dapagliflozin, fasting glucose, postprandial glucose excursion, euglycemic hyperinsulinemic clamp, euglycemic oral glucose tolerance test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
euglycemic hyperinsulinemic clamp tests and euglycemic oral glucose tolerance clamp tests after the short-term (i.e.: 3 days, equals 10mg / 24h) intake of dapagliflozin
| Study group | Role | What they receive |
|---|---|---|
| dapagliflozin | Active comparator | 10mg dapagliflozin per 24h for 3 days per cross-over phase (equals 2 x 30mg) Receives: Drug: Dapagliflozin |
| placebo sugar pills | Placebo comparator | placebo tablet, 1 per 24h for 3 days in total per cross-over phase (equals 2 x 3 tablets) Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting glucose homeostasis
During hyperinsulinemic, euglycemic clamp studies, fasting glucose homeostasis will be determined for both, dapagliflozin and placebo.
Measured: study visit, immediatly
postprandial glucose homeostasis
During euglycemic oral glucose tolerance clamp tests, postprandial glucose excursion will be determined and compared between dapagliflozin and placebo.
Measured: study visit, immediatly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion29 Jul 2016
- Study completion8 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fasting GlucoseStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz, University of Bern
- Responsible party
- Principal investigator, Markus Laimer, Medical University Innsbruck
- Investigators
- Markus Laimer, PD MD, Principal investigator, Medical University Innsbruck, Department of Internal Medicine I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211742
- Sponsor's protocol ID
- CUI_001
- Acronym
- DapaT1DM
- Status last verified
- Mar 2023
- First submitted
- 6 Aug 2014
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
DeFronzo RA, Hompesch M, Kasichayanula S, Liu X, Hong Y, Pfister M, Morrow LA, Leslie BR, Boulton DW, Ching A, LaCreta FP, Griffen SC. Characterization of renal glucose reabsorption in response to dapagliflozin in healthy subjects and subjects with type 2 diabetes. Diabetes Care. 2013 Oct;36(10):3169-76. doi: 10.2337/dc13-0387. Epub 2013 Jun 4.
PubMed 23735727Abdul-Ghani MA, DeFronzo RA. Dapagliflozin for the treatment of type 2 diabetes. Expert Opin Pharmacother. 2013 Aug;14(12):1695-703. doi: 10.1517/14656566.2013.812632. Epub 2013 Jun 26.
PubMed 23800130Mather A, Pollock C. Glucose handling by the kidney. Kidney Int Suppl. 2011 Mar;(120):S1-6. doi: 10.1038/ki.2010.509.
PubMed 21358696Plosker GL. Dapagliflozin: a review of its use in type 2 diabetes mellitus. Drugs. 2012 Dec 3;72(17):2289-312. doi: 10.2165/11209910-000000000-00000.
PubMed 23170914
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Dapagliflozin on Fasting and Postprandial Glucose Homeostasis in Male Type 1 Diabetes Patients.
- ClinicalTrials.gov ID
- NCT02211742
- Acronym / sponsor ID
- DapaT1DM / CUI_001
- Conditions
- Fasting Glucose, Glucose Excursion, Glycemic Control
- Keywords
- dapagliflozin, fasting glucose, postprandial glucose excursion, euglycemic hyperinsulinemic clamp, euglycemic oral glucose tolerance test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- Medical University of Graz, University of Bern
- Study start
- Aug 2014 (actual)
- Primary completion
- 29 Jul 2016 (actual)
- Study completion
- 8 Feb 2017 (actual)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dapagliflozin is a highly selective, reversible and potent inhibitor of the sodium-glucose-linked Transporter 2 (SGLT2), which was successfully investigated for its use as a treatment option in type 2 diabetes mellitus. The effect of dapagliflozin is an increased glucosuria, and it was shown that mean blood glucose concentrations and postprandial glucose excursion in special were significantly reduced in type 2 diabetic patients. Due to its mechanism-of action it seems likely that also type 1 diabetic patients will benefit from dapagliflozin. The present study is focused on the effects of dapagliflozin on fasting glucose homeostasis and postprandial glucose excursion in male type 1diabetic patients. Participants will subsequently receive 10 milligrams of dapagliflozin and placebo for 3 days (equals 2 x 30mg per cross-over period) in a double-blind, randomised, cross-over design. The effects will be measured via euglycemic hyperinsulinemic clamp studies (fasting glucose homeostasis) and euglycemic oral glucose tolerance clamp tests (postprandial glucose excursions).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dapagliflozin | Active comparator | Drug: Dapagliflozin10mg dapagliflozin per 24h for 3 days per cross-over phase (equals 2 x 30mg) |
| placebo sugar pills | Placebo comparator | Drug: Dapagliflozinplacebo tablet, 1 per 24h for 3 days in total per cross-over phase (equals 2 x 3 tablets) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Type 1 diabetes mellitus (duration of disease at least 5 years)
- C-peptide concentration < 0.2µg/l
- male sex
- aged 18 to 60 years
- Body Mass Index 20 - 25 kg/m2
Key exclusion criteria (8 listed)
- insufficient venous status on both forearms
- renal and/or hepatic insufficiency (including microalbuminuria and/or albumin/creatinin-ratio)
- history of cancer
- intake of medication and/or substances capable to influence insulin sensitivity within the last 3 months prior to study inclusion
- alcohol- and/or drug abuse, nicotine consumption > 5 cigarettes / 24h
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozineuglycemic hyperinsulinemic clamp tests and euglycemic oral glucose tolerance clamp tests after the short-term (i.e.: 3 days, equals 10mg / 24h) intake of dapagliflozin | Drug | dapagliflozin, placebo sugar pills |
Primary outcome
fasting glucose homeostasis
Time frame: study visit, immediatly
During hyperinsulinemic, euglycemic clamp studies, fasting glucose homeostasis will be determined for both, dapagliflozin and placebo.
postprandial glucose homeostasis
Time frame: study visit, immediatly
During euglycemic oral glucose tolerance clamp tests, postprandial glucose excursion will be determined and compared between dapagliflozin and placebo.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 23735727DeFronzo RA, Hompesch M, Kasichayanula S, Liu X, Hong Y, Pfister M, Morrow LA, Leslie BR, Boulton DW, Ching A, LaCreta FP, Griffen SC. Characterization of renal glucose reabsorption in response to dapagliflozin in healthy subjects and subjects with type 2 diabetes. Diabetes Care. 2013 Oct;36(10):3169-76. doi: 10.2337/dc13-0387. Epub 2013 Jun 4.
- Background: PubMed 23800130Abdul-Ghani MA, DeFronzo RA. Dapagliflozin for the treatment of type 2 diabetes. Expert Opin Pharmacother. 2013 Aug;14(12):1695-703. doi: 10.1517/14656566.2013.812632. Epub 2013 Jun 26.
- Background: PubMed 21358696Mather A, Pollock C. Glucose handling by the kidney. Kidney Int Suppl. 2011 Mar;(120):S1-6. doi: 10.1038/ki.2010.509.
- Background: PubMed 23170914Plosker GL. Dapagliflozin: a review of its use in type 2 diabetes mellitus. Drugs. 2012 Dec 3;72(17):2289-312. doi: 10.2165/11209910-000000000-00000.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Laimer, PD MD principal investigator
Medical University Innsbruck, Department of Internal Medicine I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin in people with Fasting Glucose and Glucose Excursion, run by Medical University Innsbruck at 1 site in Austria.
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 6 inclusion and 8 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 16 Mar 2023. 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 Austria. 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. Some participants in this study may receive a placebo. 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?
fasting glucose homeostasis (time frame: study visit, immediatly). The study lists 2 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 NCT02211742, which also lists 4 linked publications.
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 16 Mar 2023.