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Dapagliflozin in Type 1 Diabetes (DapaT1DM)

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ClinicalTrials.gov Identifier: NCT02211742
Recruitment Status : Unknown
Verified April 2015 by Markus Laimer, Medical University Innsbruck.
Recruitment status was:  Recruiting
First Posted : August 7, 2014
Last Update Posted : April 8, 2015
Sponsor:
Collaborators:
Medical University of Graz
University of Bern
Information provided by (Responsible Party):
Markus Laimer, Medical University Innsbruck

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).

Condition or disease Intervention/treatment Phase
Fasting Glucose Glucose Excursion Glycemic Control Drug: Dapagliflozin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-term Effects of Dapagliflozin on Fasting and Postprandial Glucose Homeostasis in Male Type 1 Diabetes Patients.
Study Start Date : August 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: dapagliflozin
10mg dapagliflozin per 24h for 3 days per cross-over phase (equals 2 x 30mg)
Drug: Dapagliflozin
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

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



Primary Outcome Measures :
  1. fasting glucose homeostasis [ Time Frame: study visit, immediatly ]
    During hyperinsulinemic, euglycemic clamp studies, fasting glucose homeostasis will be determined for both, dapagliflozin and placebo.

  2. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02211742


Contacts
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Contact: Markus Laimer, PD MD 0043(0)512504 ext 81411 Markus.Laimer@uki.at
Contact: Christoph Ebenbichler, Prof MD 0043(0)512504 ext 81394 Christoph.Ebenbichler@i-med.ac.at

Locations
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Austria
Medical University Innsbruck, Department of Internal Medicine I Recruiting
Innsbruck, Tirol, Austria, 6020
Contact: Markus Laimer, PD MD    0043(0)512504 ext 81411    Markus.Laimer@uki.at   
Contact: Christoph Ebenbichler, Prof MD    0043(0)512504 ext 81394    Christoh.Ebenbichler@i-med.ac.at   
Principal Investigator: Markus Laimer, PD MD         
Sub-Investigator: Christoph Ebenbichler, Prof MD         
Sub-Investigator: Andreas Melmer, MD PhD         
Sub-Investigator: Pavle Adamovski, MD         
Sponsors and Collaborators
Medical University Innsbruck
Medical University of Graz
University of Bern
Investigators
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Principal Investigator: Markus Laimer, PD MD Medical University Innsbruck, Department of Internal Medicine I

Publications:
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Responsible Party: Markus Laimer, PD MD, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT02211742     History of Changes
Other Study ID Numbers: CUI_001
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015
Keywords provided by Markus Laimer, Medical University Innsbruck:
dapagliflozin
fasting glucose
postprandial glucose excursion
euglycemic hyperinsulinemic clamp
euglycemic oral glucose tolerance test
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs