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Dapagliflozin in Type 1 Diabetes (DapaT1DM)

Primary Purpose

Fasting Glucose, Glucose Excursion, Glycemic Control

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Dapagliflozin
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fasting Glucose focused on measuring dapagliflozin, fasting glucose, postprandial glucose excursion, euglycemic hyperinsulinemic clamp, euglycemic oral glucose tolerance test

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Medical University Innsbruck, Department of Internal Medicine I

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

dapagliflozin

placebo sugar pills

Arm Description

10mg dapagliflozin per 24h for 3 days per cross-over phase (equals 2 x 30mg)

placebo tablet, 1 per 24h for 3 days in total per cross-over phase (equals 2 x 3 tablets)

Outcomes

Primary Outcome Measures

fasting glucose homeostasis
During hyperinsulinemic, euglycemic clamp studies, fasting glucose homeostasis will be determined for both, dapagliflozin and placebo.
postprandial glucose homeostasis
During euglycemic oral glucose tolerance clamp tests, postprandial glucose excursion will be determined and compared between dapagliflozin and placebo.

Secondary Outcome Measures

Full Information

First Posted
August 6, 2014
Last Updated
March 14, 2023
Sponsor
Medical University Innsbruck
Collaborators
Medical University of Graz, University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT02211742
Brief Title
Dapagliflozin in Type 1 Diabetes
Acronym
DapaT1DM
Official Title
Short-term Effects of Dapagliflozin on Fasting and Postprandial Glucose Homeostasis in Male Type 1 Diabetes Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
July 29, 2016 (Actual)
Study Completion Date
February 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University Innsbruck
Collaborators
Medical University of Graz, University of Bern

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasting Glucose, Glucose Excursion, Glycemic Control
Keywords
dapagliflozin, fasting glucose, postprandial glucose excursion, euglycemic hyperinsulinemic clamp, euglycemic oral glucose tolerance test

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dapagliflozin
Arm Type
Active Comparator
Arm Description
10mg dapagliflozin per 24h for 3 days per cross-over phase (equals 2 x 30mg)
Arm Title
placebo sugar pills
Arm Type
Placebo Comparator
Arm Description
placebo tablet, 1 per 24h for 3 days in total per cross-over phase (equals 2 x 3 tablets)
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
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
Primary Outcome Measure Information:
Title
fasting glucose homeostasis
Description
During hyperinsulinemic, euglycemic clamp studies, fasting glucose homeostasis will be determined for both, dapagliflozin and placebo.
Time Frame
study visit, immediatly
Title
postprandial glucose homeostasis
Description
During euglycemic oral glucose tolerance clamp tests, postprandial glucose excursion will be determined and compared between dapagliflozin and placebo.
Time Frame
study visit, immediatly

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Laimer, PD MD
Organizational Affiliation
Medical University Innsbruck, Department of Internal Medicine I
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Innsbruck, Department of Internal Medicine I
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
23735727
Citation
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.
Results Reference
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PubMed Identifier
23800130
Citation
Abdul-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.
Results Reference
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PubMed Identifier
21358696
Citation
Mather A, Pollock C. Glucose handling by the kidney. Kidney Int Suppl. 2011 Mar;(120):S1-6. doi: 10.1038/ki.2010.509.
Results Reference
background
PubMed Identifier
23170914
Citation
Plosker 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.
Results Reference
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Learn more about this trial

Dapagliflozin in Type 1 Diabetes

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