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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

Tracking Information
First Submitted Date  ICMJE August 6, 2014
First Posted Date  ICMJE August 7, 2014
Last Update Posted Date April 8, 2015
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02211742 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dapagliflozin in Type 1 Diabetes
Official Title  ICMJE Short-term Effects of Dapagliflozin on Fasting and Postprandial Glucose Homeostasis in Male Type 1 Diabetes Patients.
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Fasting Glucose
  • Glucose Excursion
  • Glycemic Control
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: dapagliflozin
    10mg dapagliflozin per 24h for 3 days per cross-over phase (equals 2 x 30mg)
    Intervention: Drug: 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 6, 2014)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2015
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02211742
Other Study ID Numbers  ICMJE CUI_001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Markus Laimer, Medical University Innsbruck
Study Sponsor  ICMJE Medical University Innsbruck
Collaborators  ICMJE
  • Medical University of Graz
  • University of Bern
Investigators  ICMJE
Principal Investigator: Markus Laimer, PD MD Medical University Innsbruck, Department of Internal Medicine I
PRS Account Medical University Innsbruck
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP