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Dapagliflozin in Type 1 Diabetes

Information source: Medical University Innsbruck
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fasting Glucose; Glucose Excursion; Glycemic Control

Intervention: Dapagliflozin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Medical University Innsbruck

Official(s) and/or principal investigator(s):
Markus Laimer, PD MD, Principal Investigator, Affiliation: Medical University Innsbruck, Department of Internal Medicine I

Overall contact:
Markus Laimer, PD MD, Phone: 0043(0)512504, Ext: 81411, Email: Markus.Laimer@uki.at

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).

Clinical Details

Official title: Short-term Effects of Dapagliflozin on Fasting and Postprandial Glucose Homeostasis in Male Type 1 Diabetes Patients.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

fasting glucose homeostasis

postprandial glucose homeostasis

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Male.

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.

Locations and Contacts

Markus Laimer, PD MD, Phone: 0043(0)512504, Ext: 81411, Email: Markus.Laimer@uki.at

Medical University Innsbruck, Department of Internal Medicine I, Innsbruck, Tirol 6020, Austria; Recruiting
Markus Laimer, PD MD, Phone: 0043(0)512504, Ext: 81411, Email: Markus.Laimer@uki.at
Christoph Ebenbichler, Prof MD, Phone: 0043(0)512504, Ext: 81394, Email: Christoh.Ebenbichler@i-med.ac.at
Markus Laimer, PD MD, Principal Investigator
Christoph Ebenbichler, Prof MD, Sub-Investigator
Andreas Melmer, MD PhD, Sub-Investigator
Pavle Adamovski, MD, Sub-Investigator
Additional Information

Related 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.

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. Review.

Mather A, Pollock C. Glucose handling by the kidney. Kidney Int Suppl. 2011 Mar;(120):S1-6. doi: 10.1038/ki.2010.509. Review.

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. Review.

Starting date: August 2014
Last updated: April 7, 2015

Page last updated: August 23, 2015

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